Example 001 76 Merged

Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 04:50:22 GMT)
CTRI Number CTRI/2010/091/002816 [Registered on: 18/10/2010] -

Last Modified On 06/01/2015
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Drug
Study Design Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain
Scientific Title of A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter C
Study Study of Eslicarbazepine Acetate in Diabetic Neuropathic Pain
Secondary IDs if Any Secondary ID
BIA-2093-307 (Version 1.0, Final 26 Apr 2010)
NCT01129960
Details of Principal Details of Principal Inv

Investigator or overall Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Address
Phone
Fax
Email
Details Contact Details Contact Person (Sc

Person (Scientific Name Arun Sundriyal
Query)
Designation Associate Director Clinical Managemen
Affiliation PPD Pharmaceutical Development (I) P
Address PPD Pharmaceutical Development Indi
Centre, First India Place, 2nd floor, Blo
Mehrauli Gurgaon Road Gurgaon
Gurgaon
HARYANA
122002
India
Phone 911244028861
Fax 911244028874
Email Arun.Sundriyal@ppdi.com
Details Contact Details Contact Person (P

Person (Public Query) Name Arun Sundriyal
Designation Associate Director Clinical Managemen
Affiliation
Centre, First India Place, 2nd floor, Blo
Mehrauli Gurgaon Road Gurgaon
Gurgaon
HARYANA
122002
India
Phone 911244028861
Fax 911244028874
Source of Monetary or Source of Monetary or Ma

Material Support > Bial - Portela C S.A. À Avenida da Siderurgia Nacional, Apartado 19, 4745-457 S. Mam
Coronado, Portugal
Primary Sponsor Primary Sponsor D

Name Bial Portela C SA
Address Bial - Portela C S.A. À Avenida da Side
4745-457 S. Mamede do Coronado, Po
Type of Sponsor Pharmaceutical industry-Global
Details of Secondary Name

Sponsor PPD Pharmaceutical Development India Pvt Ltd
Countries of List of Countries

Recruitment Argentina
Austria
Chile
Germany
India
Israel
Mexico
Russian Federation
South Africa
Spain
United Kingdom
Name of Principal Name of Site
Investigator
Sites of Study Name of Principal Name of Site
Investigator
Dr. Deepak Dewan Ajanta Hospital & IVF
Centre
Dr. Paramesh Bangalore Clinisearch

Shamanna
Dr. M M Mehndiratta G. B. Pant Hospital, #

502, Academic Block,
Department of
Neurology
Dr. Krishnan Vijayan Kovai Medical Center

and Hospital Ltd.
Dr. Sandeep Kumar M.V. Hospital and

Gupta Research Centre
Dr. Bhawna Sharma Sawai Man Singh

Medical College
Hospital
Dr. Suresh Kumar Vijaya Health Centre
Details of Ethics Name of Committee Approval Status

Committee
Bangalore Central Approved
Ethics Committee
Bio-Ethics Forum of Approved
Lucknow
Ethics committee - SMS Approved
Medical College and
Hospital
Ethics Committee, Approved
Kovai Medical Center
and Hospital
Institutional Ethics Approved
Committee, M V
Hospital and Research
Centre

Committee, Maulana
Azad Medical College
The Ethics Committee, Approved
Vijay Health Centre
Regulatory Clearance Status

Status from DCGI Approved/Obtained
Health Condition / Health Type

Problems Studied Patients
Intervention / Type Name
Comparator Agent Intervention Eslicarbazepine acetate (BIA
2-093)
Intervention Eslicarbazepine acetate (BIA
2-093)
Intervention Eslicarbazepine acetate (BIA
2-093)
Comparator Agent Placebo
Inclusion Criteria Inclusion Crite

Age From 18.00 Year(s)
Age To 65.00 Year(s)
Gender Both
Details 1. Male and female outpatients aged 18
subjects are of nonchildbearing potenti
sterilization (hysterectomy or bilateral o
or at least 2 years postmenopausal (sp
least 24 months before Visit 1), or if of
subjects agree to use a medically acce
of contraception. 2. Diagno
diabetes mellitus. 3. Pain d
polyneuropathy caused by Type 1 or Ty
 4. Have stable glycemic control, a
investigator, and have glycosylated hem
equal than 11 percent before randomiz
score between 4.0 and 9.0, inclusive, o
intensity assessment and Visit 3 (ie, 5 o
days, or 7 of 10 days). 6. C
completion. 7. If not used to
permitted to take nonsteroidal anti infla
serotonin reuptake inhibitors if they wer
month prior to Screening and are fores
throughout the study. 8. Com
give own informed consent. 
childbearing potential, who are not curr
have a negative serum pregnancy test
Exclusion Criteria Exclusion Crite

Details 1. Historical exposure to drugs known t
Significant skin lesions (active infection
vascular disease with a history of ampu
toes. 4. Known intolerance to ESL or to
derivatives (eg, carbamazepine or oxca
severe allergic reactions with multiple m
previously participated in a clinical stud
psychiatric disorders. 7. Serious or uns
compromise participation cause hospita
Second or third degree atrioventricular
pacemaker or any clinically significant a
electrocardiogram as determined by the
taking the following drug classes and in
benzodiazepines (except short half life
muscle relaxants, orally administered s
centrally acting analgesics (dextrometh
topical lidocaine, anticonvulsants, tricyc
serotonin norepinephrine reuptake inhib
minimum washout period of at least 5 t
be tapered appropriately using product
10. Relevant clinical laboratory abnorm
opinion, can compromise the subject's
abuse or dependence (drug categories
the past year, excluding nicotine and ca
the previous 30 days, received treatme
received regulatory approval for any ind
entry. 13.History of recurrent epileptic s
seizures. 14.History of severe gastropa
surgery. 15.Neurolytic treatment for DN
steroid use within 30 days of Visit 1. 17
years. 18. History of chronic hepatitis B
or human immunodeficiency virus infec
above the age of 65 years are not bein
India, as per Regulatory approval grant
General of India (DCGI).
Method of Generating Computer generated randomization

Random Sequence
Method of Centralized
Centralized
Concealment
Blinding/Masking Participant, Investigator and Outcome Assessor Blinded
Primary Outcome Outcome
To assess the efficacy of ESL as therapy in

subjects with Diabetic Neuropathic Pain.
The primary efficacy variable will be based on
the response to a 11 point NRPS relating to pain
intensity. This will be used to generate the
primary efficacy variable of change from
Baseline to endpoint in mean pain.
Secondary Outcome Outcome

Worst daily pain and worst night pain (change
from Baseline to endpoint in worst daily pain and
night pain is defined in the same way as the
primary efficacy endpoint).
Weekly mean pain intensity (calculated from the

11-point NRPS)
Responder rates (reduction of at least 30% or at
least 50% compared with baseline based on the
11-point NRPS average pain score)
Time to response (time in days to the first of 2
consecutive days after randomization with
average pain score at least 2 points below
baseline mean pain, based on the 11-point
NRPS average pain score)
Patient and clinical global impression of change

(subjects rate their change in the overall status
answering the question on the scale)
Short Form McGill Pain Questionnaire (subjects
complete this questionnaire as a qualitative
assessment of their pain and their affective
response to pain).
Allodynia Visual Analog Scale (subjects rate the

allodynia severity after mechanic allodynia
evoked pain).
Chronic Pain Sleep Inventory (subjects complete
this inventory to assess the impact of their pain
on sleep).
Rescue medication use (number of days from
first intake of double-blind study drug to first
intake of rescue medication and the mean
amount of paracetamol per study day will be
derived)
Target Sample Size Total Sample Size=468

Sample Size from India=80
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated
Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated
Phase of Trial Phase 3

Date of First 19/11/2010
Enrollment (India)
Enrollment (Global)
Estimated Duration of Years=2
Trial Months=0
Days=0
Recruitment Status of Other (Terminated)

Trial (Global)
Trial (India)
Publication Details NA
Brief Summary The present study will investigate the effect of 3 ESL doses (800, 1200, or 1600 mg OD) i
with DNP compared with placebo. There will be a 19-week double-blind study phase com
3-week titration phase, followed by a 12-week treatment maintenance phase, and a 4-wee
follow-up phase comprising a 3-week tapering phase. A titration phase is included as this
expected to decrease the AE incidence during the treatment maintenance phase. After the
double-blind phase, subjects will have the option to enter a subsequent 36-week OL phas
treatment (32-week OL ESL treatment at flexible doses between 800 mg and 1600 mg ES
followed by a 4-week tapering phase). Apart from India, other country participating in the s
UK, Argentina, Austria, Chile, Germany, Israel, Mexico, Russia, South Africa, and Spain. T
number of subjects planned to be recruited from India is 80 and first subject enrollment is
01 Nov 2010. The study is open for subject recruitment in India. The study was premature
terminated.

Post Graduate Thesis
Type of Trial
Type of Study
Study Design Single Arm Study
Public Title of Study A Clinical Trial to evaluate the safety and efficacy of zonisamide an antiepileptic drug in tr
patients with seizures (Fits). This is a postmarketing study to further confirm the safety an
in large number of patients in the approved types of seizures.
Scientific Title of Evaluation of Safety and Efficacy of Zonisamide in Adult Patients with Partial, Generalized
Study Combined Seizures: An Open Labeled, Non-comparative, Observational Study Acronym:
Zonisamide

EIL/ZONE/CT01/010

Investigator or overall Name Dr. A.V. Srinivasan
Trial Coordinator
Designation
Affiliation
Address Trinity Acute Care Hospital Mylapore
Chennai
TAMIL NADU
600017
India
Phone +919940066963
Fax
Email avsekhar1950@gmail.com

Person (Scientific Name Dr Amitabh Dash
Query)
Designation Regional Medical Advisor
Affiliation Regional Medical Advisor
Address Eisai Pharmaceuticals India Private Lim
Marwah Centre, Krishanlal Marwah Ma
Pharmaceuticals India Private Limited,
Centre, Krishanlal Marwah Marg, Andh
Mumbai
MAHARASHTRA
400072
India
Phone 02261311311
Fax 02228579720
Email a-dash@eisai.co.in

Person (Public Query) Name Dr Amitabh Dash
Name Dr Amitabh Dash
Designation Regional Medical Advisor
Affiliation Regional Medical Advisor
Address Eisai Pharmaceuticals India Private Lim
Pharmaceuticals India Private Limited,
Centre, Krishanlal Marwah Marg, Andh
Mumbai
MAHARASHTRA
400072
India
Phone 02261311311
Fax 02228579720
Email a-dash@eisai.co.in

Material Support > This study is funded by the Eisai Pharmaceuticals India Private Limited with registered o
1st Floor, B-Wing, Marwah Centre, Krishanlal Marwah Marg, Andheri East, Mumbai - 400

Name Eisai Pharmaceuticals India Private Lim
400072
Address
Type of Sponsor

Sponsor NONE
Recruitment India
Investigator
Dr. Sunit Kumar Shah Advanced Neurology &
Superspeciality Hospital
Dr. Arulselvan Apollo Hospitals

Dr. Adabala Kiran Ayush Neuro Clinic
Dr. Neeraj Bjutani Bhutani Neuro Care
Dr. Manjunath CBI Road
Dr. Shivkumar Cerebrovascular &

Vasculitis Research
Foundation
Dr. Ashutosh Shetty Criticare Multispeciality

Hospital and Research
Centre
Dr. Raja Ram Agarwal Fortis Escorts Hospital
PDF of Trial
CTRI Website
Dr. Dinesh Nayak Global Hospital & Perumbakkam,-600100

Health City Chennai
TAMIL NADU
Dr. Murali K. Menon Krishna Clinic Ashwadhy, Ambika Niv

as,Tripunithura-682301
Not Applicable
N/A
Dr. Vidya Lisie Hospital ,-682018

Not Applicable
N/A
Dr. Bobby Varkey Lourdes Hospital ,-682012

Not Applicable
N/A
Dr. Mahesh Mahesh Child Care and T-Nagar,-600017
Neurocare Chennai
TAMIL NADU
Dr. Renu Achtani Mata Chanan Devi Janakpuri,-110070

Hospital New Delhi
DELHI
Dr. B. Jyothi Medplus Clinic Vijay Nagar
Colony,-500057
Hyderabad
ANDHRA PRADESH
Dr. Vivek Kumar Metrohospital & Heart X-1, Sector 12,-201301

Institute Not Applicable
N/A
Dr. Asad Abbas Nurocare & Research ,-226003

Centre Lucknow
UTTAR PRADESH
Dr. Sreedhar Sai Krishna Kachiguda,-500027

Superspeciality Neuro Hyderabad
Hospital ANDHRA PRADESH
Dr. Veeresh Bajpai Sai Neurology Clinic ,-226022

Lucknow
UTTAR PRADESH
Dr. Jitender Singh Sanjivani Hospital Near Vastrapur

lake,Vastrapur-3800015
Ahmadabad
GUJARAT
Dr. Suresh Gupta Santokba Durlabji Bhavani Singh

Memorial Hospital cum Marg,-304015
Medical Research Jaipur
Institute RAJASTHAN
Dr. Sangeeta Ravat Seth GSMC & KEM Parel,-400012

Hospital Mumbai
MAHARASHTRA
Dr. R.V. Narayana Seven Hills Hospital Waltair Main
Road,-530002
Visakhapatnam
ANDHRA PRADESH
Dr. Ruchir Divatia Shrey Hospital

Dr. Ruchir Divatia Shrey Hospital
Dr. Velmurugendran Sri Ramchandra

University
Dr. C. H. Gopal Swetha Clinic
Dr. A.V. Srinivasan Trinity Acute Care

Hospital
Dr. N. Pushpa Raju Varun Neuro Clinic
Dr. G. Satyanarayana Vijaya Healthcare

Hospital
Dr. V.N. Mathur Vivekananda Hospital

Committee
Cerebral Independent Approved
Review Board
Review Board, 301/A,
Lenaine Road, Abids,
Hyderabad - 500001

Hyderabad - 500001

Hyderabad - 500001

Hyderabad - 500001

Hyderabad - 500001
Hyderabad - 500001

PDF of Trial
CTRI Website
Hyderabad - 500001
Cerebral Independent Approved No Date Specified
Hyderabad - 500001

Hyderabad - 500001

Hyderabad - 500001

Hyderabad - 500001

Hyderabad - 500001

Hyderabad - 500001

Hyderabad - 500001

Hyderabad - 500001
Hyderabad - 500001

Hyderabad - 500001

Hyderabad - 500001

Hyderabad - 500001

Hyderabad - 500001

Hyderabad - 500001

Hyderabad - 500001
Cerebrovascular & Approved

Vasculitis Research
Foundation Ethics
Committee,
Rajarathinam Street,
Kilpauk, Chennai -
600010
Ethics Committee for Submittted/Under

Research on Human Review
Subjects, Seth GSMC &
KEM Hospital, Acharya
Dhonde Marg, 2nd
Floor, R.No. 223, Old
Building, Parel, Mumbai
- 400012
Ethics Committee, Submittted/Under
Apollo Hospitals, Apollo Review
Hospitals Enterprises
Limited, 21-Greams
Lane, Greams Road,
Chennai - 600006
Institutional Ethics Submittted/Under

Committee, Global Review
Hospital & Health City,
439, Cheran Nagar,
Perumbakkam,
Chennai - 600100

Committee, Sri
Ramchandra Medical
Centre, Sri
Ramchandra University,
A-2, Neurology, Porur,
Chennai - 600116
Metro Hospital & Heart Submittted/Under

Institute Ethics Review
Committtee, X-1, Sector
12, Noida - 201301
Sanjivani Hospital Submittted/Under

Ethics Committee, Review
Sanjivani Hopsital, Near
Vastrapur Lake,
Vastrapur, Ahmedabad
- 380015

Problems Studied

Comparator Agent Intervention zonisamide 100mg tablets
Comparator Agent Not applicable

Age From
Age To
Gender
Details 1.Male or female subjects, 18 to 75 yea
or untreated subjects suffering from an
seizures: a.Partial Seizures: Simple Pa
Partial Seizures & Secondarily gen
b.Generalized Seizures: Tonic-clonic se
Atypical absence seizures c.Combined
having had a computed tomography (C
imaging (MRI) done within the last upto
progressive cause of epilepsy. 4.Fema
bearing potential (2 years postmenopau
or tubal ligation, complete hysterectom
subjects with childbearing potential mu
confirmed by a negative pregnancy tes
must not be lactating and must be usin
of contraception, for the duration of the
following discontinuation of the study d
the medications as directed, maintain a
events and willing to come for the follow
7.Willing to comply with the protocol req
to give the written informed consent.

Details 1.Subjects with history of non-epileptic
pseudo-seizures). 2.Subjects who have
relating to drugs, alcohol, acute medica
or subjects with situation related seizur
progressive encephalopathy or findings
CNS disease or lesion (e.g. infection, d
4.Subjects with a history of any signific
disease which in the opinion of the inve
conduct of this study or the assessmen
study drug. 5.Subjects already receivin
6.Subjects who have received an inves
in the past three months before screen
with known hypersensitivity to zonisam
8.Subjects with known abnormal renal
>1.5 mg/dL) or abnormal hepatic functi
aminotransferase [AST] and alanine am
times the upper normal limit). 9.Subject
illness or mood disorder requiring elect
within previous 6 months which is cons
of suicide attempt; alcohol or drug abus
taking carbonic anhydrase inhibitors (a
currently taking Mono-Amine Oxidase I
12.Subjects having a history of pancrea
hypercalciuria, clinically significant labo
suggestive of metabolic imbalance.
Method of Generating Other

Random Sequence
Method of Not Applicable
Concealment
Blinding/Masking Open Label
Safety of zonisamide based on adverse event
reportedand Patients Global Assessment of

Tolerability to Therapy (PGATT) on a 4-point
scale Reduction in Seizure Frequency compared
to baseline over 24 weeks treatment period

Assessment of Responder Rates and Seizure
Freedom with zonisamide

Final Enrollment numbers achieved (Total)=
Final Enrollment numbers achieved (India)=

Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Trial Months=0
Days=0
Recruitment Status of Not Applicable

Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details
Brief Summary This is an open labeled non-comparative, multicentric observational post marketing surve
study to comparing the safety and efficacy of zonisamide as adjunctive therapy or monoth
patients with partial, generalized or combined seizures, in a initiating dose of 100mg/day t
a maximum of 600mg per day based on the seizure control and tolerability over a 24 week
treatment period. This study will include a total of 900 patients with partial, generalized or
seizures across 30 centres in the country. The patients will be enrolled based on the inclu
exclusion criteria and will be evaluated for safety and efficacy at every 4 weekly interval fo
weeks. There will be total 7 study visits and the patients will be evaluated for clinically rep
adverse events, safety on Patients Global Assessment of Tolerability to Therapy (PGATT
4-point scale and for efficacy by evaluation of reduction in seizure frequency as the prima
objective of the study. For secondary objectives the patients data will be evaluated to dete
responder rates (> or = to 50% reduction in seizure frequency from baseline) and seizure
over the 24 weeks study period.

Last Modified On
Type of Trial
Type of Study
Study Design Randomized, Parallel Group, Active Controlled Trial
Public Title of Study A Study on Comparative Efficacy of Amitriptyline versus Propranolol in the Prophylaxis of
Migraine
Scientific Title of A Study on Comparative Efficacy of Amitriptyline versus Propranolol in the Prophylaxis of
Study Migraine
NIL

Investigator or overall Name Tina Thomas
Trial Coordinator
Designation
Affiliation
Address M Pharm student college of pharmaeut
College, Trivandrum
Not Applicable
N/A
695011
India
Phone 09961749486
Fax
Email tinathomas2287@gmail.com

Person (Scientific Name Dr. Thomas Iype
Query)
Designation
Affiliation
Address Professor and Head of Department of N
Trivandrum
Not Applicable
N/A
695011
India
Phone 09446230317
Fax
Email beenaiype@gmail.com

Person (Public Query) Name Dr. Thomas Iype
Designation
Affiliation
Address Professor and Head of Department of N
Trivandrum
Not Applicable
N/A
695011
India
Phone 09446230317
Fax
Email beenaiype@gmail.com

Material Support > nil

Primary Sponsor D
Name nil
Address
Type of Sponsor

Sponsor nil

Recruitment India
Investigator
Dr.Thomas Iype department of
neurology, medical
college, trivandum

Committee
Human Ethics Submittted/Under
Committee, medical Review
college, trivandrum

Status from DCGI Not Applicable
Problems Studied

Comparator Agent Intervention amitriptyline
Comparator Agent propranolol

Age From
Age To
Gender
Details patients diagnosed with chronic migrain
age > 10 years

Details patients with asthma, depression, anxie
retardation patients using anti convulsa
drugs, MAO inhibitors
Method of Generating Random Number Table

Random Sequence
Method of Case Record Numbers
Concealment
change in migraine score (M score)before and
after therapy

changes in disability associated with migraine
and migraine associated symptoms before and
after therapy changes in anxiety and depression
before and after therapy

Sample Size from India=
Phase of Trial N/A

Enrollment (India)
Enrollment (Global)
Trial Months=6
Days=0
Recruitment Status of Not Yet Recruiting

Trial (Global)
Recruitment Status of
Trial (India)
Publication Details
Brief Summary This study is a randomized controlled trial comparing the efficacy of Amitriptyline and Prop
the treatment of Chronic migraine. Each treatment arm requires 45 patients. Primary outc
measured by comparing the baseline migraine score ( M score ) and score after 33 month
therapy.M score reflects the frequency,severity and duration of headaches. The centre is
department of neurology, medical collge, trivandrum, kerala, India.The secondary outcom
thechanges in disability associated with migraine and migraine associated symptoms befo
after therapy .

Last Modified On
Type of Trial
Type of Study
Study Design Other
Public Title of Study Role of new diagnostic test i.e. Interferon Gamma Release Assay (IGRA)in diagnosis and
of tuberculous meningitis patients
Scientific Title of MTB complex Interferon Gamma Release Assay (IGRA) in blood and CSF of Tuberculous
Study meningitis patients
NIL

Investigator or overall Name Vidhate Mukund Ramrao
Trial Coordinator
Trial Coordinator
Designation
Affiliation
Address Dept of neurology, CSMMU, chowk De
chowk
Lucknow
UTTAR PRADESH
226003
India
Phone 02532531658
Fax 05222258805
Email drmukundvidhate@yahoo.co.in

Person (Scientific Name Vidhate Mukund Ramrao
Query)
Designation
Affiliation Senior resident
chowk
Lucknow
UTTAR PRADESH
226003
India
Phone 02532531658
Fax 05222258805

Person (Public Query) Name Vidhate Mukund Ramrao
Designation
Affiliation
chowk
Lucknow
UTTAR PRADESH
226003
India
Phone 02532531658
Fax 05222258805

Source of Monetary or Ma
Material Support > NIL

Name NIL
Address
Type of Sponsor

Sponsor NIL

Recruitment India
Investigator
Dept of neurology,
CSMMU, chowk

Committee
Committee of CSMMU,
Lucknow

Problems Studied

Comparator Agent Intervention NIL
Comparator Agent NIL

Age From
Age To
Gender
Details 1. Fever, headache, meningismus, othe
presentations of meningitis of more tha
cerebrospinal fluid (CSF) features inclu
than 20 cells, lymphocytes greater than
100mg% and glucose level less than 60
blood glucose level. Presumptive diagn
based on the clinical criteria with typica
one of the following supporting criteria:
based on chest X-ray that confirmed pu
pattern in upper lobes with or without c
Hydrocephalous from brain computeriz
Response to anti-tuberculous treatmen

Details 1. The patients who already received m
antituberculous drugs and steroids. 2. T
consent.
Method of Generating Not Applicable
Random Sequence
Concealment
Blinding/Masking Not Applicable
Death or severe disability assessed by modified
Rankin scale

NIL

Phase of Trial N/A

Enrollment (India)
Enrollment (Global)
Trial Months=6
Days=0

Trial (Global)
Trial (India)
Publication Details
Brief Summary Background: Interferon Gamma Release Assay (IGRA) is the newer diagnostic tool for rap
diagnosis of tuberculosis, but its role in tuberculous meningitis (TBM) is not well establishe
present study, we evaluated the sensitivity and specificity of IGRA in blood and CSF of TB
patients and also studied its role in prognosis. We also compared IGRA results with the re
Tuberculin Skin Test (TST) and CSF mycobacterial polymerase chain reaction (PCR). Me
this case control study, we performed IGRA by QuantiFERON-TB Gold In-Tube test (QFT
blood and CSF of 36 TBM cases and 16 control subjects. Also, the blood and CSF interfe
gamma levels were repeated at 6 months of treatment in 6 TBM cases. The diagnostic an
prognostic value of IGRA for TBM was assessed. Results: Sixteen patients (44.4%) in TB
group (N=36) and 6 patients (37.5%) in control group (N=16) tested positive by whole bloo
QFT-G-IT at baseline. The difference was statistically insignificant (p=0.64). The CSF QFT
was not useful in diagnosis as 54/58 (93.1%) results were indeterminate due to poor mitog
response. We found good agreement between blood IGRA response and TST results (77
κ=0.56±0.13; p=0.001). Thirteen patients (36.11%) in TBM group had positive CSF
Mycobacterium tuberculosis. ROC curve plotted between blood interferon gamma levels a
PCR results fell below standard curve [area under curve = 0.306 (95% CI: 0.228-0.384); p
Baseline blood interferon gamma levels didn?t predict outcome at 6 months. The mean bl
interferon gamma level increased insignificantly from 1.83±4.01 IU/mL at baseline to 3.18±
IU/mL at 6 months (p=0.24). The IGRA responses at 6 months were highly inconsistent.
Conclusions: The whole blood IGRA had low sensitivity (44.4%) and specificity (62.5%) in
diagnosing TBM and also it didn?t predict the outcome. CSF IGRA was not useful either in
Background: Interferon Gamma Release Assay (IGRA) is the newer diagnostic tool for rap
diagnosis of tuberculosis, but its role in tuberculous meningitis (TBM) is not well establishe
present study, we evaluated the sensitivity and specificity of IGRA in blood and CSF of TB
patients and also studied its role in prognosis. We also compared IGRA results with the re
Tuberculin Skin Test (TST) and CSF mycobacterial polymerase chain reaction (PCR). Me
this case control study, we performed IGRA by QuantiFERON-TB Gold In-Tube test (QFT
blood and CSF of 36 TBM cases and 16 control subjects. Also, the blood and CSF interfe
gamma levels were repeated at 6 months of treatment in 6 TBM cases. The diagnostic an
prognostic value of IGRA for TBM was assessed. Results: Sixteen patients (44.4%) in TB
group (N=36) and 6 patients (37.5%) in control group (N=16) tested positive by whole bloo
QFT-G-IT at baseline. The difference was statistically insignificant (p=0.64). The CSF QFT
was not useful in diagnosis as 54/58 (93.1%) results were indeterminate due to poor mitog
response. We found good agreement between blood IGRA response and TST results (77
κ=0.56±0.13; p=0.001). Thirteen patients (36.11%) in TBM group had positive CSF
Mycobacterium tuberculosis. ROC curve plotted between blood interferon gamma levels a
PCR results fell below standard curve [area under curve = 0.306 (95% CI: 0.228-0.384); p
Baseline blood interferon gamma levels didn?t predict outcome at 6 months. The mean bl
interferon gamma level increased insignificantly from 1.83±4.01 IU/mL at baseline to 3.18±
IU/mL at 6 months (p=0.24). The IGRA responses at 6 months were highly inconsistent.
Conclusions: The whole blood IGRA had low sensitivity (44.4%) and specificity (62.5%) in
diagnosing TBM and also it didn?t predict the outcome. CSF IGRA was not useful either in
diagnosis or prognosis, due to indeterminate results. Robustness of blood IGRA response
observed at 6 months. The observations need confirmation from studies in large number o
patients, especially from high tuberculosis prevalence countries.
CTRI Number CTRI/2012/12/003175 [Registered on: 04/12/2012] - Trial Registered Retrospectively

Type of Study Behavioral
Study Design Other
Public Title of Study Efficacy of counseling in non -epileptic seizures
Scientific Title of Psychological counseling in Non -Epileptic Seizures
Study
NIL

Investigator or overall Name Dr Manjari Tripathi
Trial Coordinator
Trial Coordinator
Designation Additional professor
Affiliation Dept. of Neurology
Address Room-705, 7th floor ,Dept. of Neurolog
New Delhi
DELHI
110029
India
Phone 01126594494
Fax 01126588248
Email manjari.tripathi@gmail.com

Person (Scientific Name sangita sharma
Query)
Designation Senior Research Fellow
Affiliation
New Delhi
DELHI
110029
India
Phone 01126594494
Fax 01126588248
Email sangita1811@gmail.com

Person (Public Query) Name sangita sharma
Designation Senior Research Fellow
Affiliation
New Delhi
DELHI
110029
India
Phone 01126594494
Fax 01126588248
Email sangita1811@gmail.com

Material Support > NON-FUNDED
Name AIIMS
Address all India Institute of Medical Sciences-N
Type of Sponsor Research institution and hospital

Sponsor NIL
Recruitment India
Investigator
Dr Manjari Tripathi AIIMS

Committee
Institute Ethics Approved
Committee,All India
Institute of Medical
Sciences New Delhi


Comparator Agent Comparator Agent counselling
Comparator Agent Cognitive Behavior Therapy

Intervention CBT & Counselling

Gender Both
Details 1) All non-epileptic Patients. 
children above 10 years. 

Details 1) Person with Epilepsy
2) Persons with epilepsy with NES
2) Persons with any other disease
3) Children below 10 years.

Random Sequence
Method of Sequentially numbered, sealed, opaque envelopes
Concealment
Blinding/Masking Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Provision of both counselling and CBT will prove
better in eclectic management and speedy
recovery process of the patient in comparison to
either one treatment procedure used in isolation.

Quality of life Profile of patients with PNES
Presence of any other Psychiatric co morbidity

Phase of Trial N/A

Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Recruitment Status of Open to Recruitment
Trial (India)
Publication Details
Brief Summary Psychogenic non-epileptic seizures (PNES), also known as non-epileptic atta
PDF of Trial
CTRI Website
disorders (NEAD), are events with psychological origin that superficially resembles
an epileptic seizure, but without the characteristic electrical discharges associated
with epilepsy. Patients with PNES tend to display significantly distorted somatic beliefs and develop
dysfunctional, repetitive illness behaviour patterns with associated depressive affect, higher
incidence of dissociative symptoms and general pathological symptoms as compared to patients
with epilepsy. A review of work done in recent past highlights that treatment trials for psychogenic
non-epileptic seizures (PNES) are few, despite the high prevalence and disabling nature of the
disorder ( La France, 2009). Hence, a Randomized controlled trial is planned to assess the efficacy
of a Cognitive behavior Therapy and Counselling as a combined approach for the management of
patients with psychogenic non epileptic seizures as compared to application of CBT or Counselling
as an individual treatment approach. The primary objective of our study is to assess the
effectiveness of a combined treatment model (both CBT and Counselling intervention) in reduction
of PNES. The secondary objective of our study is to assess the effectiveness of Individual
treatment model of CBT and Counselling in reduction of PNES and to draw a comparison between
combined treatment model and individual treatment model. A sample of 200 PNES patients,
diagnosed on the bases of EEG findings, both males and females, belonging to age range of 10-65
years will be recruited. Person with epilepsy, person with epilepsy with co-morbid NES, or Person
with other neurological or psychological co-morbidity will be excluded from the study. MINI Interview
schedule and WHO Quality of life BREF Scale will be used to assess the psychological conditions
of the patients, both at pre and post intervention stages. The recruited sample group will be
randomly assigned to three sub-groups, Group A: CBT and Counselling Intervention, Group B: CBT
intervention and Group C: Counselling Intervention. 12 weekly session of CBT and 4 weekly
sessions of counselling will be given. A comparative analysis hence will be drawn between the three
subgroups to identify the most effective treatment approach in management of PNES patients.

Last Modified On
Type of Trial
Type of Study
Study Design Other
Public Title of Study Ocurrence of hydrocephalus in tuberculous meningitis and its effect on the survival and re
Scientific Title of Hydrocephalus in Tuberculous meningitis:Incidence,predictive factors and its impact on th
Study prognosis
NIL

Investigator or overall Name tushar raut MD
Trial Coordinator
Designation
Affiliation
Address dept of neurology C.S.M.M.U(chchatrap
university, Lucknow
Lucknow
UTTAR PRADESH
220663
India
Phone 07398910149
Fax -
Email tushar.27r@gmail.com

Person (Scientific Name tushar raut MD
Query)
Designation
Affiliation
university, Lucknow
Lucknow
UTTAR PRADESH
220663
India
Phone 07398910149
Fax -

Person (Public Query) Name tushar raut MD
Designation
Affiliation
university, Lucknow
Lucknow
UTTAR PRADESH
220663
India
Phone 07398910149
Fax -

Material Support > C.S.M.M.U, Chchatrapati shahu maharaj medical university,lucknow..
Name Nil
Address
Type of Sponsor

Sponsor Nil
nil

Recruitment India
Investigator
prof.R.K.Garg (DM chchatrapati shahu
Neurology) maharaj medical
university and upgraded
king george medical
college(KGMC)
Lucknow.

Committee
Institutional ethics com Approved
mittee,C.S.M.M.U,luckn
ow

Problems Studied

Comparator Agent Intervention nil
Intervention nil
Comparator Agent nil

Age From
Age To
Gender
Details Patients will be included in the study- A
Shankar et al Fever , headache, signs
clinical presentations of meningitis laste
Typical cerebrospinal fluid (CSF) featur
more than 20 cells, lymphocytes greate
than 100mg% and glucose level less th
blood glucose level. Sterile bacterial an

Details 1. Patients who have already taken AT
Patients with cryptococcal meningitis 3
meningitis detected during the course o
not available or problematic follow up is

Random Sequence
Concealment
Glasgow coma scale,disability as per modified
barthal's index,MRC staging of TBM.

nil

Phase of Trial N/A

Enrollment (India)
Enrollment (Global)
Months=0
Days=0
Years=2
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details
Brief Summary Suspected cases of TBM in neurology department of CSMMU History and clinical examin
routine analysis and culture for MTB MRI Brain for evaluation of hydrocephalus Patient as
with Barthel Index and MRC staging for TBM patients on enrollment Follow up MRI and pa
assesment to reasses improvement, severity and disability

Last Modified On
Type of Trial
Type of Study
Study Design Other
Public Title of Study A clinical trial to study the level of inflammatory mediators like cytokinines and metalloprot
cerebro spinal fluid of patients with subacute sclerosing panencephalitis.
Scientific Title of Cerebrospinal Fluid Proinflammatory Cytokines and Matrix Metalloproteinases in Patients
Subacute Sclerosing Panencephalitis.
Cerebrospinal Fluid Proinflammatory Cytokines and Matrix Metalloproteinases in Patients
Study Subacute Sclerosing Panencephalitis.
NIL

Investigator or overall Name DR NAVIN KUMAR TIWARI
Trial Coordinator
Designation
Affiliation
Address senior resident, departement of neurolo
medical university LUCKNOW
Lucknow
UTTAR PRADESH
226003
India
Phone 07662225043
Fax -
Email navintiwari14@gmail.com

Person (Scientific Name PROFF. R K GARG
Query)
Designation
Affiliation
Address HOD, DEPARTEMENT OF NEUROLO
medical university,KGMC
Lucknow
UTTAR PRADESH
226003
India
Phone 05222258852
Fax
Email garg50@yahoo.com

Person (Public Query) Name PROFF. R K GARG
Designation
Affiliation
Address HOD, DEPARTEMENT OF NEUROLO
medical university,KGMC
Lucknow
UTTAR PRADESH
226003
India
Phone 05222258852
Fax

Material Support > DEPARTEMENT OF NEUROLOGY,CHATRAPATISAHU JI MAHARAJ MEDICAL
UNIVERSITY,LUCKNOW

Name DEPARTEMENT OF NEUROLOGY,CH
MAHARAJ MEDICAL UNIVERSITY, LU
Address
Type of Sponsor

Sponsor nil

Recruitment India
Investigator
PROFF. R K GARG DEPARTEMENT OF N
EUROLOGY,CHATRA
PATI SAHUJI
MAHARAJ MEDICAL
UNIVERSITY

Committee
INSTITUTIONAL Approved
ETHICS COMMITTEE,
OFFICE OF
RESEARCH CELL,
CSMMU ,LUCKNOW
UTTAR PRADESH
226003

Problems Studied

Comparator Agent Intervention lumbar puncture to obtain csf
sample 1 ml. of patients of
subacute sclerosing
panencephalitis
Comparator Agent csf of control patients 1 ml
.patients who are undergoing
spinal anesthesia

Age From
Age To
Gender
Details all patients of subacute sclerosing pane
jabbour criterion
Details patients of tubercular meningitis,AIDS,f

meningitis ,viral encephalitis and other

Random Sequence
Concealment
LEVELS OF PROINFLAMMATORY MARKERS
IN CSF OF PATIENTS WITH SUBACUTE
SCLEROSING PANENCEPHALITIS

nil

Phase of Trial N/A

Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details
Brief Summary a case control study of inflammatory mediators in patients of sub acute sclerosing panenc

Type of Study Drug
Public Title of Study 13-WEEK STUDY FOR EVALUATION OF EFFICACY AND SAFETY OF IN-AQUL-002 TA
COMPARED TO OXCARBAZEPINE SUSTAINED-RELEASE TABLET AS ADJUNCTIVE
TREATEMENT IN ADULT PATIENTS WITH REFRACTORY PARTIAL-ONSET SEIZURE
Scientific Title of AN OPEN LABEL, RANDOMIZED, PARALLEL GROUP, PROSPECTIVE, MULTICENTRE

Study CLINICAL TRIAL FOR EVALUATION OF EFFICACY AND SAFETY OF IN-AQUL-002 IN
COMPARISON WITH OXCARBAZEPINE SUSTAINED-RELEASE AS ADJUNCTIVE
TREATEMENT IN ADULT PATIENTS WITH REFRACTORY PARTIAL-ONSET SEIZURE

CT/IN-AQUL-002/EPI/III/10

Details of Principal Inv
Investigator or overall Name Dr Rajendra C Rane
Trial Coordinator
Designation Sr Vice President
Affiliation Intas Pharma
Address Intas Pharmaceuticals Ltd Chinubhai C
Ahmadabad GUJARAT 380009 India In
Chinubhai Center Ashram Road Ahmad
India
Ahmadabad
GUJARAT
380009
India
Phone 26576655
Fax 26576616
Email rane@intaspharma.com

Person (Scientific Name Dr Kanhei Charan Sahoo
Query)
Designation Medical adviser
Affiliation Medical Advisor
India
Ahmadabad
GUJARAT
380009
India
Phone 66523302
Fax 26576616
Email Kanheicharan_sahoo@intaspharma.co

Person (Public Query) Name Dr Dimple Shah
Designation Medical adviser
Affiliation Intas Pharma

India
Ahmadabad
GUJARAT
380009
India
India
Ahmadabad
GUJARAT
380009
India
Phone 66523298
Fax 26576616
Email dimple_shah@intaspharma.com

Material Support > Intas Pharmaceuticals Limited, Ahmedabad
Name Intas Pharmaceuticals Limited
Ahmadabad GUJARAT 380009 India
Type of Sponsor Pharmaceutical industry-Indian

Sponsor Nil
Recruitment India
Investigator
Dr. M A Majid Apex Superspecialty
Hospital
Dr. Pradyumna Oak Ashirvad clinic
Dr Abhay Bhagwat CHL Apollo Hospital
Dr. Mayank Patel Dr. Mayank Patel?s

Clinic
Dr. Nitin Sampat Dr. Nitin Sampat?s
clinic
Dr. Shalin Shah Dr. Shalin Shah?s clinic
Dr. Rajaram Agarwal Fortis Escorts Hospital
Dr. Prafulla Shembelkar Gatewell Hospital
Dr. Monika Malokar Malokar Hospital
Dr. N Sase Miraj Wanless Hospital
Dr. Manoj Rajani Nupur Clinic

Dr. Nirmal Surya Surya Neuro Centre

Committee
Convenient Hospitals
Limited - Dr. Abhay
Bhagwat

Fortis Escorts Hospital-
Dr. Rajaram Agrawal
Wanless Hospital- Dr. N
Sase
Manav -Independent Approved
Ethics Committee- Dr.
M A Majid
Manoj Rajani

Mayank Patel
Monika Malokar
Nirmal Surya
Nitin Sampat
Pradyumna Oak
Shalin Shah

Comparator Agent Intervention IN-AQUL-002
Comparator Agent Oxcarbazepine

sustained-release

Gender Both
Details 1. Patients of either sex, 18 to 65 years
undergoing treatment with one to three
for simple or complex partial seizures w
generalization & having history of at lea
in the previous 4 weeks before screenin
with childbearing potential, non-pregna
negative serum pregnancy test at scree
contraceptive throughout the study trea
willing to provide written informed cons
comply with the study requirements suc
seizure diary and self administration of
the study treatment period

Details Patients with 1. Only simple partial seiz
symptoms, 2. Primarily generalized epi
progressive neurological disorder, 4. St
seizures within 3 months before screen
psychogenic origin within the last two y
schizophrenia or suicide attempts 7. An
medical disorder 8. Ongoing use of disa
oxcarbamazepine, feblamate, diuretics
desmopressin, 9. Cardiac arrhythmia in
blockade 10. Clinical laboratory abnorm
2.5 times upper normal limit; or sodium
blood cell count < 3,000 cells/mm3; hem
ng/100ml & T3 < 2.4 pg/ml; or serum cr
1.5mg/100ml). 11. History of drug or alc
previous 2 years 12. Known hypersens
oxcarbazepine formulations 13. Particip
drug trial within 3 months preceding stu
inappropriate for enrollment by investig
reasons.

Random Sequence
Concealment
Change in the seizure frequency rate

1. Responder Rate
2. Change in number of seizure free days


Enrollment (India)
Enrollment (Global)
Months=10
Days=0
Years=0
Trial Months=10
Days=0

Trial (Global)
Trial (India)
Publication Details Nil

Brief Summary The aim of this study is to compare the efficacy and safety of IN-AQUL-002 with oxcarbaz
sustained-release as adjunctive treatment in adult patients with refractory partial onset se
expected that IN-AQUL-002 oral tablets will be more effective in controlling seizure freque
safe in comparison to oxcarbazepine sustained-release tablets as adjunctive treatment of
patients with refractory partial onset seizures. The trial will be conducted in Indian patients
within India only. Anticipated date for first patient enrolment in the study is 27th December

Post Graduate Thesis Yes
Type of Trial Observational
Type of Study Follow Up Study
Study Design Other
Public Title of Study Inflammatory markers in tuberculous meningitis
Scientific Title of Cerebrospinal fluid proinflammatory cytokines and matrix metalloproteinases in HIV serop
Study and seronegative patients of tuberculous meningitis
NIL

Investigator or overall Name Dheeraj Rai
Trial Coordinator
Designation MBBS, MD
Affiliation senior resident
Address Department of Neurology Chhatrapati S
University
Lucknow
UTTAR PRADESH
226003
India
Phone 05222733707
Fax
Email dr.dheeraj.rai@gmail.com

Person (Scientific Name Prof R K Garg DM
Query)
Designation DM Neurology
Affiliation professor of neurology, CSMMU
University,
Lucknow
UTTAR PRADESH
226003
India
Phone 05222733707
Fax

Person (Public Query) Name Prof R K Garg DM
Name Prof R K Garg DM
Designation
Affiliation
University,
Lucknow
UTTAR PRADESH
226003
India
Phone 05222733707
Fax

Material Support > Nil
Name Nil
Address Not Applicable
Type of Sponsor Other [NIL]

Sponsor NIL
Recruitment India
Investigator
Dheeraj rai Chhatrapati Shahuji
Maharaj Medical
University,

Committee
Committee, CSMMU,
Uttar Pradesh

Not Applicable
Gender Both
Details 1. Patients fulfilling diagnostic criteria o
based on Thwaites et al 17criteria 
positive for HIV 1 or 2 for HIV positive g
years 

Details 1. Patients not fulfilling above criteria 2
meningitis 3. Patients/ attendants refus

Random Sequence
Concealment
1. complete response
2. partial response
3. poor response
4. death

NIL

Phase of Trial N/A

Enrollment (India)
Enrollment (Global)
Months=0
Days=0
Years=2
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details NIL
Brief Summary The inflammatory response and production of cytokines (TNF- IL-1, IL-2, IL-6, IFN- in
cerebrospinal fluid of patients with tuberculous meningitis are well documented. The cytok
necrosis factor alpha (TNF- is critical in the neuropathogenesis of M. tuberculosis. Althoug
plays a definitive role in granuloma formation and containment of mycobacterial infections
CNS production of TNF-in experimental bacterial meningitis leads to altered blood-brain b
(BBB) permeability and cerebrospinal fluid (CSF) leukocytosis 10,11 and has been implica
fostering the progression of TBM in a murine model. There is evidence of significant blood
barrier (BBB) breakdown in patients with TBM. The mechanisms are probably multifactori
although the matrix metalloproteinases (MMPs) have been recently implicated. This thesis
primarily to estimate concentration of proinflammatory cytokines (TNF- IL-1, IL-10 and IFN
matrix metalloproteinase(MMP-2 and MMP- 9) in cerebrospinal fluid of patients with tuber
meningitis in HIV positive and HIV negative patients and its clinical correlation with diseas
and outcome.
CTRI/2010/091/006121 [Registered on: 17/01/2011] -

Last Modified On
Type of Trial
Type of Study
Public Title of Study Music listening by mothers during pregnancy affects Newborn Behaviour
Scientific Title of Maternal music exposure during pregnancy influences Neonatal Behaviour
Study
NIL

Investigator or overall Name Ravindra Arya
Trial Coordinator
Designation
Affiliation
Address SRA Pediatric Neurology, Dept of Pedi
New Delhi
DELHI
110 029
India
Phone
Fax
Email ravindra.arya4@gmail.com

Person (Scientific Name Maya Chansoria
Query)
Designation
Affiliation Prof. & HOD Pediatrics, NSCB Medical
Address Dept of Pediatrics NSCB Medical colleg
Jabalpur
MADHYA PRADESH
482003
India
Phone 07612422117
Fax
Email maya.chansoria@yahoo.com

Person (Public Query) Name Maya Chansoria
Designation
Affiliation
Address Dept of Pediatrics NSCB Medical colleg
Jabalpur
MADHYA PRADESH
482003
India
Phone 07612422117
Fax
Email maya.chansoria@yahoo.com
Material Support > Department of Pediatrics, NSCB Medical College, Jabalpur, MP
Name Department of Pediatrics, NSCB Medic
Address
Type of Sponsor

Sponsor NIL
None

Recruitment India
Investigator
Dr. Maya Chansoria Department of
Pediatrics, NSCB
Medical College,
Jabalpur, MP

Committee
NSCB Medical College,
Jabalpur, MP

Problems Studied

Comparator Agent Intervention Music
Comparator Agent Standard care

Age From
Age To
Gender
Details * Primigravida mothers * 19 to 29 years
* Less than 20 weeks of gestation

Details * Mothers with significant co-existing m
profound hearing loss
Method of Generating Random Number Table

Random Sequence
Concealment
performance on Brazelton Neonatal Behavioral
Assessment Scale (BNBAS)

Nil

Phase of Trial Phase 3/ Phase 4

Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details
Brief Summary Objective: Auditory stimulation during pregnancy has been found to influence foetal behav
a potential of being carried forward to neonatal period. This study evaluated the effect of a
music exposure to primigravida healthy mothers on the behaviour of their term appropriate
newborns assessed using Brazelton Neonatal Behavioral Assessment Scale (BNBAS). M
This was a single centre, randomized, open-label controlled trial. Primigravida mothers ag
years, free of chronic medical diseases or significant deafness, with singleton pregnancy,
gestation of 20 weeks or less were randomized to listen to a pre-recorded music cassette
approximately 1 hour/day in addition to standard ante-natal care (intervention arm) or stan
only (control arm). Peri-natal factors with adverse effect on neonatal behaviour were deem
protocol violations. Outcome measure included scores on 7 clusters of BNBAS. Primary a
was per protocol.
Objective: Auditory stimulation during pregnancy has been found to influence foetal behav
a potential of being carried forward to neonatal period. This study evaluated the effect of a
music exposure to primigravida healthy mothers on the behaviour of their term appropriate
newborns assessed using Brazelton Neonatal Behavioral Assessment Scale (BNBAS). M
This was a single centre, randomized, open-label controlled trial. Primigravida mothers ag
years, free of chronic medical diseases or significant deafness, with singleton pregnancy,
gestation of 20 weeks or less were randomized to listen to a pre-recorded music cassette
approximately 1 hour/day in addition to standard ante-natal care (intervention arm) or stan
only (control arm). Peri-natal factors with adverse effect on neonatal behaviour were deem
protocol violations. Outcome measure included scores on 7 clusters of BNBAS. Primary a
was per protocol.

Interventional
Type of Study Drug
Public Title of Study This study is designed to assess the safety and efficacy of an anti-epileptic drug, Brivarac
offering relief to adult patients suffering from a particular type of epilepsy or fits (partial on
seizures)
Scientific Title of A Randomized, Double-Blind, Placebo Controlled, Multicenter, Parallel Group Study To E
Study the Efficacy and Safety of Brivaracetam in Subjects (16 To 80 Years Old) With Partial Ons
Seizures

N01358
NCT01261325

Trial Coordinator
Designation
Affiliation
Address
Phone
Fax
Email

Person (Scientific Name Dr Aparna Parikh
Query)
Designation Executive Director & Country Consultan
Affiliation Pharmaceutical Research Associates I
Address The Qube, A-602 & A-603, C.T.S.No.14
Andheri (East), Mumba1 Mumbai (Subu
A-603, C.T.S.No.1498 A/2 M.V. Road,
Mumba1 Mumbai (Suburban)
Mumbai (Suburban)
MAHARASHTRA
400 059
India
Phone 91-2271234107
Fax 91-2271234198
Email ParikhAparna@prahs.com

Person (Public Query) Name Jigar Lakhani
Designation Clinical Team Manager
Affiliation PRA International
Address The Qube, A-602 & A-603, C.T.S.No.14
Andheri (East), Mumba1 Mumbai (Subu
A-603, C.T.S.No.1498 A/2 M.V. Road,
Mumba1 Mumbai (Suburban)
Mumbai
MAHARASHTRA
400059
India
Phone 91-2271234129
Fax 91-2271234198
Email LakhaniJigar@prahs.com

Material Support > UCB Pharma Alfred-Nobel-Stra 10, 40789 Monheim, Germany,

Name SCHWARZ BIOSCIENCES INCA Mem
Companies
Address Alfred-Nobel-Stra 10, 40789 Monheim,

Sponsor PRA International

Recruitment Austria
Belgium
Brazil
Canada
China
Czech Republic
India
Italy
Mexico
Netherlands
Poland
Republic of Korea
Russian Federation
Spain
Sweden
Taiwan
Ukraine
United States of America

Investigator
Dr Salvadeeswaran Apollo Specialty
Meenakshi Sudaram Hospital,
Dr Roop kumar Department of

Gursahani Neurology,
Dr Sangeeta Ravat Department of

Neurology, Seth GS
Medical College and
KEM Hospital,
Dr. Rangashetty Gokula Metropolis

Srinivasa Clinical Research
Center,
Dr Sita Jayalaskhmi Krishna Institute of

Medical Sciences Ltd,
Dr Rahul Bhimrao Neurocare

Baviskra

Name of Committee Approval Status
Committee
Apollo Hospitals Approved
Clinical Research and Approved
Ethics Committee
Ethical review Approved
Board-M.S. Ramaiah
Medical College &
teaching Hospital
Ethics Committee For Approved

Research On Human
Subjects- KEM
Committee
Committee-KIIMS


Comparator Agent Intervention Brivaracetam (BRV).
Inclusion Criteria
Inclusion Crite
Gender Both
Details To be eligible to participate in this study
must be met: 1. An Institutional Re
(IRB)/Independent Ethics Committee (I
informed consent form is signed and da
parent(s) or legal representative. The c
assent form, where required, will be sig
minors. 2. Subject/legal represent
and capable of adhering to the protoco
complete diaries), visit schedule, or me
the judgment of the Investigator. 3
from 16 to 80 years, both inclusive. Sub
only be included where legally permitte
4. Subjects with a body weight &#8805
subjects without childbearing potential
postmenopausal for at least 2 years, bi
ligation, complete hysterectomy) are el
childbearing potential are eligible if they
contraceptive method. Oral or depot co
least 30μg ethinylestradiol per int
ethinylestradiol per intake if associated
inducer (eg carbamazepine, phenobarb
oxcarbazepine, St. John?s Wort, rifamp
relationship with vasectomized partner,
contraception are acceptable methods.
the consequences and potential risks o
sexual activity, be educated about and
contraceptive methods, and undertake
any potential change in status.Abstinen
acceptable method ofcontraception if th
that the subject agrees to be compliant
focal epilepsy/epileptic syndrome accor
League Against Epilepsy (ILAE) classif
an EEG reading compatible with the cli
epilepsy within the last 5 years. 8.
MRI/computed tomography (CT) scan p
years. 9. Subjects having at least
seizures (according to the 1981 IL
8-week Baseline Period with at least 2
each 4-week interval of the Baseline Pe
having at least 2 partial onset seizures
generalized per month during the
11. Subjects being uncontrolled while tr
concomitant AED(s). Vagal Nerve
and will be counted as a concomitant A
concomitant AED(s) and VNS being sta
the subject from at least 1 month
phenytoin, and primidone) before
stable during the Baseline and Treatme
Benzodiazepine taken more than once
will be considered as a concomita

Details Subject previously randomized within th
study with BRV as a dosing arm.
Seizure type IA (1981 ILAE classificatio
type.
PDF of Trial
CTRI Website URL - http://ctri.nic.in
Subject has participated in another study of an investigational

medication (or a medical device) within the last 30 days or is
currently participating in another study of an investigational
medication (or a medical device).
Subject is currently treated with LEV.
Subject has taken LEV within 90 days prior to V1.
Subject has any medical or psychiatric condition that, in the opinion
of the Investigator, could jeopardize or would compromise the
subject?s ability to participate in this study.
Subject has a known hypersensitivity to any components of the
investigational medicinal product or comparative drugs as stated in
this protocol.
Subject not able to read and understand the informed consent form,
assent form, or seizure diary card instructions.
Subject has obvious cognitive impairment or mental retardation as
per Investigator assessment.
Subjects whose seizures could not be reliably counted on a regular
basis due to their fast and repetitive occurrence (clusters or flurries).
Subject has history or presence of status epilepticus during the year
preceding V1 or during Baseline.
Subject has history or presence of known psychogenic nonepileptic
seizures.
Subject on felbamate with less than 18 months exposure before V1.
Subject currently on vigabatrin. Subject with history of vigabatrin use
but either no visual fields examination report available including
standard static (Humphrey or Octopus) or kinetic perimetry
(Goldman) or results of these examinations are abnormal.
Subject taking any drug with possible central nervous system (CNS)
effects except if stable from at least 1 month before V1 and expected
to be kept stable during the Treatment Period.
Subject taking any drug that may significantly influence the
metabolism of BRV cytochrome P450 (potent inducers) except if the
dose has been kept stable at least 1 month before V1, and is
expected to be kept stable during the Treatment Period.
Subject has history of cerebrovascular accident, including transient
ischemic attack, in the last 6 months.
Subject is suffering from severe cardiovascular disease or peripheral
vascular disease
Subject has presence of any sign (clinical or imaging techniques)
suggesting rapidly progressing (ie, not expected to stay stable during
study participation) brain disorder or brain tumor. Stable
arteriovenous malformations, meningiomas, or other benign tumors
may be acceptable.
Subject has any clinical conditions (eg, bone marrow depression,
chronic hepatic disease, and/or severe renal impairment) which
impair reliable participation in the study or necessitate the use of
medication not allowed by protocol.
Subject has presence of a terminal illness.
Subject has presence of a serious infection.
Subject has history of severe adverse hematologic reaction to any
drug.
Subject is suffering from severe disturbance of hemostasis.
Subject has impaired hepatic function: ALT/SGPT (alanine
aminotransferase/serum glutamic pyruvate transaminase),
AST/SGOT (aspartate aminotransferase/serum glutamic oxaloacetic
transaminase), alkaline phosphatase of more than 2 times the upper
limit of the reference range.
Gamma-glutamyltransferase (GGT) values of more than 3 times the
upper limit of the reference range. A result of GGT exceeding 3 times
the upper limit can only be accepted if attributable to hepatic enzyme
induction caused by concomitant antiepileptic treatment and other
page 5 / 7
hepatic enzymes are below 2 times the

range.
Subject has clinically significant deviati
values for laboratory parameters: creat
30mL/min, platelets 100,000/?L, or neu
Subject has clinically significant ECG a
Investigator.
Subject has history of suicide attempt p
Subject has ongoing psychiatric diseas
disorder.
Subject has known allergic reaction or
derivatives and/or investigational produ
Subject has known multiple drug allerg
Subject is pregnant or lactating woman
Subject has known alcohol or drug add
2 years.
Investigators, co-Investigators, their sp
study collaborators. If the Investigator h
concerning the eligibility, he/she should
Physician or representative for clarifica
Method of Generating Stratified block randomization

Random Sequence
Method of On-site computer system
Concealment
Blinding/Masking Participant and Outcome Assessor Blinded
To evaluate the efficacy of BRV at varies doses
compared to placebo as adjunctive treatment in
adult focal epilepsy subjects with partial onset
seizures not fully controlled despite current
treatment with 1 or 2 concomitant AEDs

Percent reduction in partial onset seizure (Type
I) frequency from the Baseline to the Treatment
Period
Categorized percent reduction form Baseline in
seizure frequency for partial onset seizure (Type
I) over the Treatment Period
Seizure freedom rate (all seizure types) during
the 12-week Treatment Period
Time to the first Type I seizure during the
Treatment Period
Time to the fifth Type I seizure during the
Treatment Period
Time to the tenth Type I seizure during the
Treatment Period


Enrollment (India)
Enrollment (Global)
Trial Months=2
Days=24
Trial (Global)
Trial (India)
Publication Details
Brief Summary This adequate and well-controlled study will be performed to provide additional data confir
efficacy and safety of Brivaracetam as an Anti Epileptic Drug and to support a marketing
authorization application/new drug application for Brivaracetam in the indication of adjunc
treatment in adults 16 years) with refractory Partial Onset Seizures whether or not second
generalized. N01358 will assess Brivaracetam doses of 100 and 200mg/day. Consistent w
previous fixed dose Phase III studies N01253 and N01252, N01358 will include an 8-week
Period and a 12-week Treatment Period. The primary efficacy variable of N01358 will be P
Onset Seizures (Type I) frequency per 28 days over the Treatment Period. In India, we ar
targetting to enroll 210 patients .
Subject Recruitment is completed.
This adequate and well-controlled study will be performed to provide additional data confir
efficacy and safety of Brivaracetam as an Anti Epileptic Drug and to support a marketing
authorization application/new drug application for Brivaracetam in the indication of adjunc
treatment in adults 16 years) with refractory Partial Onset Seizures whether or not second
generalized. N01358 will assess Brivaracetam doses of 100 and 200mg/day. Consistent w
previous fixed dose Phase III studies N01253 and N01252, N01358 will include an 8-week
Period and a 12-week Treatment Period. The primary efficacy variable of N01358 will be P
Onset Seizures (Type I) frequency per 28 days over the Treatment Period. In India, we ar
targetting to enroll 210 patients .
Subject Recruitment is completed.
CTRI Number CTRI/2011/07/001898 [Registered on: 19/07/2011] - Trial Registered Prospectively

Type of Study Drug
Study Design Non-randomized, Multiple Arm Trial
Public Title of Study A study to determine that long term safety and efficacy of an anti-epileptic drug Brivaracet
used in combination with other agents in adult patients with epilepsy or fits (partial onset s
Scientific Title of An Open label, Multicentre, Follow up study to evaluate the long term safety and efficacy
Study Brivaracetam used as adjunctive treatment in subject aged 16 years or older with Epilepsy
N01379
NCT01339559, Protocol Amendment 3 dated 15
May 2015

Trial Coordinator
Designation
Affiliation
Address
Phone
Fax
Email

Person (Scientific Name Dr Aparna Parikh
Query)
Designation Executive Director & Country Consultan
Address The Qube, A-603, C.T.S.No.1498 A/2 M
(East), Mumbai Mumbai (Suburban) Th
C.T.S.No.1498 A/2 M.V. Road, Marol, A
Mumbai (Suburban)
Mumbai
MAHARASHTRA
400053
India
Phone 91-2271234107
Fax 91-2271234198
Email ParikhAparna@prahs.com

Person (Public Query) Name Jigar Lakhani
Designation Clinical Team Manager
Address The Qube, A-603, C.T.S.No.1498 A/2 M
(East), Mumbai Mumbai (Suburban) Th
C.T.S.No.1498 A/2 M.V. Road, Marol, A
Mumbai (Suburban)
Mumbai (Suburban)
MAHARASHTRA
400 059
India
Phone 91-2271234129
Fax 91-2271234198
Email LakhaniJigar@prahs.com

Material Support > UCB BIOSCIENCES, INC., 8010 Arco Corporate Drive, Suite 100 Raleigh, NC 27617 U
STATES

Name SCHWARZ BIOSCIENCES INC A Mem
Companies
Address 8010ArcoCorp.Drive, Suite 100,Raleigh

Sponsor PRA International

Recruitment Austria
Belgium
China
Czech Republic
Germany
Hungary
Israel
Italy
Netherlands
Romania
Singapore
Spain
Taiwan
United Kingdom

Investigator
Dr Salvadeeswaran Apollo Speciality
Meenakshi Sudaram Hospitals
Dr Sita Jayalaskhmi Krishna Institute of

Medical Sciences Ltd,
Dr. Rangashetty M.S.Ramaiah Memorial

Srinivasa Hospital
Dr Rahul Baviskar Neurocare
Dr. Roop kumar PD Hinduja National

Gursahani Hospital and Medical
Research Centre
Dr. Sangeetha Ravat Seth G. S. Medical
College, K.E.M.
Hospital

Committee
Apollo hospitals Approved
Clinical Research and Approved
Ethics committee
Ethical Review Board Approved
Ethics committee for Approved
Research on Human
subjects
Committee- KIIMS
Shatabdi Hospital Approved
Ethics Committee


Problems Studied Healthy Human Volunteers
Comparator Agent Intervention Brivaracetam

Gender Both
Details Subject completed the Treatment Perio
for whom the Investigator believes a re
long term administration of BRV may b

Details Subject has developed hypersensitivity
investigational medicinal product (IMP)
stated in this protocol during the course
Severe medical, neurological, or psych
values which may have an impact on th
Poor compliance with the visit schedule
previous BRV study
Any medical condition which, in the Inv
exclusion

Random Sequence
Concealment
The primary efficacy variable is the POS (type I)
seizure frequency standardized to a 28-day
duration.

The secondary objective is to evaluate the
maintenance of efficacy of
BRV over time.


Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details NA
Brief Summary UCB is developing BRV(Brivaracetam) as an adjunctive antiepileptic treatment in subjects
and older suffering from focal epilepsy. N01379 will give subjects who have completed N0
opportunity to access BRV (Brivaracetam) under the present protocol. N01358 is an adeq
well-controlled study to provide additional data confirming the efficacy and safety of BRV
(Brivaracetam) as an AED (Anti Epiletic Drug) in adults (more than or equal to16 years) w
refractory POS whether or not secondarily generalized. N01379 will explore the long-term
and efficacy of BRV (Brivaracetam) in subjects with POS (Partial Onset Seizures) whethe
secondarily generalized while providing access to BRV (Brivaracetam) for subjects who m
from open-label treatment with BRV (Brivaracetam) .
Study is globally in recruitment. In India recruitment has started.

Last Modified On
Type of Trial
Type of Study
Study Design Other
Public Title of Study effect of swelling around the bleed in brain on the outcome in patients with hemorrhagic s
Scientific Title of perihematomal edema as predictor of outcome in intracerebral hemorrhage
Study
NIL

Investigator or overall Name Mani Gupta
Trial Coordinator
Designation
Affiliation
Address Senior resident, Dept of neurology King
Lucknow
UTTAR PRADESH
226003
India
Phone 09997618747
Fax -
Email mani04in2003@yahoo.co.in

Person (Scientific Name Mani Gupta
Query)
Designation
Affiliation nil
Lucknow
UTTAR PRADESH
226003
India
Phone 09997618747
Fax -

Person (Public Query) Name Mani Gupta
Designation
Affiliation
Lucknow
UTTAR PRADESH
226003
India
Phone 09997618747
Fax -

Material Support > nil
Name nil
Address
Type of Sponsor

Sponsor nil
Recruitment India
Investigator
prof.Rajesh Verma DM chchatrapati shahuji
neurology maharaj medical
university

Committee
Institutional ethics Approved
committee

Problems Studied

Comparator Agent Intervention nil

Age From
Age To
Gender
Details  Patients with SICH pres
the onset of the acute symptoms would
Age > 18 years

Details ? Intraventricular extension ? Infratento
anticoagulation ? bleeding disorders ?
intracranial neoplasm ? presence of AV
at admission ? Presence of end organ
failure and others)

Random Sequence
Concealment
Disability as per NIHS score, Barthal index and

MRS and mortality
Disability as per NIHS score, Barthal index and
MRS and mortality

nil

Phase of Trial N/A

Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details
Brief Summary INTRODUCTION Stroke is defined as a focal neurologic deficit of vascular cause extendin
24 hours or is interrupted by death. The hemorrhagicstorke constitute 10-15% of all stroke
these are spontaneous intracerebralhemorrhage( SICH ). SICH are known for a very deva
outcome, 30 day mortality as high as 50%..Studies have shown that activation of multiple
pathophysiologic processes are involved in the genesis of the perihematomaledema. The
evidence that local coagulation activation produces thrombin which leads to blood brain b
disruption and neuronal cell damage.The importance of local coagulation activation is und
the finding that D-dimer is elevated (without any systemic coagulation activation ) in patien
SICH compared to normal individual. This process is particularly important in the first 24 h
the hemoglobin is released from the RBCs in the hematoma clot the ferric iron produces o
injury contributing to perihematomaledema. A positive correlation has been suggested be
raised serum ferritin levels and peak perihematomaledema at day 3 or day 4 by Manu Me
al. Furthermore the use of desferroxamine has been found to modify the perihematomaled
growth. Other factors contributing to edema formation include local cytokine activation, hig
glutamate levels, hyperglycemia and body temperature. Our study is aimed at defining the
perihematomaledema as a predictor of 30 day mortality and 12 week outcome in SICH, an
study the correlation between the D-dimer level, glycosylated hemoglobin and serum ferri
with perihematomal volume.

Type of Study Drug
Public Title of Study A clinical trial to study the effects of two drugs, ozarelix and goserelin in men with prostate
Scientific Title of An International, Multi-Center, Open Label, Randomized Study Assessing the Safety and
Study a Monthly Dosing Regimen of Ozarelix versus Goserelin Depot (Zoladex) in Men with Pro
Cancer

NCT01252693
SPI-153-10-1

Investigator or overall Name Dr Sunita Rajadhyaksha
Trial Coordinator
Designation
Affiliation
Address OncoRx Pharma Pvt Ltd, 85 Mittal Cha
Nariman Point , Mumbai 400021
Mumbai
MAHARASHTRA
400021
India
Phone 02232092464
Fax 02222022380
Email sunita.rajadhyaksha@oncorxindia.com

Person (Scientific Name Dr Sunita Rajadhyaksha
Query)
Designation
Affiliation Medical Director
Mumbai
MAHARASHTRA
400021
India
Phone 02232092464
Fax 02222022380

Person (Public Query) Name Dr Sunita Rajadhyaksha
Designation
Affiliation
Mumbai
MAHARASHTRA
400021
India
Phone 02232092464
Fax 02222022380

Material Support > NIL
Primary Sponsor D
Name Spectrum PharmaceuticalsInc
Address 157 Technology Drive, Irvine CA 92618
(949)788-6700Facsimile:(949)788-6700

Sponsor OncoRx Pharma Pvt Ltd

Recruitment India

Investigator
Dr Sanjay Garg khushi maternity and
surgical centre
Dr Shivadeo S Bapat Ratna Memorial

Hospital
Dr Ajit Saxena Ajit Surgical and

Maternity Centre
Dr Apul Goel Chhatrapati Shahuji

Maharaj Medical
University
Dr Chandra Shekhar Choithram Hospital &

Thatte Research Centre
Dr Kim Mammen Christian Medical

College and Hospital
Dr Kapil Pankajbhai Excel Hospital, An

Thakkar Advanced Urology and
Laparoscopy Centre
Dr Anil Mohanlal Excel Urology Centre

PDF of Trial
CTRI Website
Bradoo Cinema,Dr. C. G. Road,

Chembur, Mumbai -
400074
Mumbai (Suburban)
MAHARASHTRA
Dr Madan Mohan Fortis Escorts Hospital Jawahar Lal Nehru
Bansal Marg, Malviya Nagar,
Jaipur - 302017
Jaipur
RAJASTHAN
Dr Raghunath S K HCG Bangalore No 8, HCG Towers, P.

Institute Of Oncology Kalinga Rao Road,
Sampangi Rama
Nagar, Bangalore -
560027
Bangalore
KARNATAKA
Dr Hemang Baxi HCG Medi-Surge 1,Nr. Mithakhali Six

Hospitals Roads, Ellisbridge,
Ahmedabad - 380006
Ahmadabad
GUJARAT
Dr Suresh H Advani Jaslok Hospital & Department of Medical

Research Centre Oncology,15, Dr G.
Deshmukh
Marg,Mumbai 400062
Mumbai
MAHARASHTRA
Dr Mahesh Desai Muljibhai Patel Dr. Virendra Desai

Urological Hospital Road, Nadiad-387001
Ahmadabad
GUJARAT
Dr Rajendra Kashinath Noble Hospital 153, Magarpatta City R

Shimpi oad,Hadapsar,Pune-41
1 028
Pune
MAHARASHTRA
Dr Shrenik Shah Rushabh Uro Hospital 2nd floor, Heritage

Plaza, Opp. Gurukul
Tower, Drive in Road,
Ahmedabad - 380052
Ahmadabad
GUJARAT
Dr Janak Desai Samved Hospital Urology Department,
On Stadium Circle to
Commerce College Six
Roads, Navrangpura,
Ahmedabad - 380009
Ahmadabad
GUJARAT
Dr Hemant Rangnath TNMC & BYL Nair Department of

Pathak Hospital Urology,Second
Floor,College Building,
Mumbai Central -
400008
Mumbai (Suburban)
MAHARASHTRA
Dr Divakar Dalela Uro-Health Research Center2/503, Vikas
Center
Dr N K Mohanty Vardhaman Mahavir

Medical College And
Safdarjung Hospital
Dr Kalyan Kumar Woodland Medical

Sarkar Centre Limited

Committee
Clinical Ethics Forum Approved
for Ajit surgical and
maternity centre
for Excel Hospital, An
Advanced Laparoscopy
and Urology Centre

for Excel Urological
Centre
for Khushi Maternity
and surgical hospital
for Rushabh Uro
Hospital
Ethical Committee Approved
Safdarjung Hospital
Ethics Committee of Approved
B.Y.L. Nair Charitable
Hospital And T.N.
Medical College
Ethics Committee Approved

Samved Hospital
HCG - Central Ethics Approved
Committee
HCG Medi-Surge Ethics Approved
Committee
Independant Ethics Approved
Committee for
Uro-Health Research
Centre
Institution Ethics Approved

committe, Fortis Escort
Hospital
committee, Chhatrapati
Shahuji Maharaj
Medical University

committee, Choithram
Hospital and reseacrh

centre
Institutional ethics Approved
committee, CMC and
Hospital, Ludhiana
committee, Muljibhai
Patel society for
research in
Nephro-urology
Committee, Noble
Hospital
committee, Woodlands
Medical centre
Jaslok Hospital and Approved
research centre Ethics
committee
Maharashtra Medical Approved
Research Society


Comparator Agent Intervention ozarelix
Comparator Agent Goserelin

Gender Male
Details Patients, aged 18 years or older, with h
cancer of any stages, for whom endocr

Details Any hormone therapy prior to study ent

Random Sequence
Concealment
Percentage of patients with testosterone less
than or equal to 0.5ng/mL in each group

1)Testosterone surge
2)Percentage of patients with less than or equal
to 0.5 ng/ml
3) median time to reach 50% suppression of
baseline PSA level
4) Safety

Final Enrollment numbers achieved (Total)=49
Final Enrollment numbers achieved (India)=102

Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details Information regarding use or publication of study-related information will be provided to th
Investigator in the Clinical Trial Agreement.
Brief Summary Study is conducted in USA and India. The aim of this study is to assess the safety and eff
monthly regimen of ozarelix administered SC versus Goserelin depot administered SC in
Prostate Cancer. This is an international, multi-center, randomized, open label 84 days stu
who are at least 18 years of age or older, with histologically proven prostate cancer of all s
whom endocrine treatment is indicated will be eligible for study entry. Prospective study s
will undergo screening procedures. Approximately 214 eligible patients will enter the study
will be randomized in a 1:1 ratio to one of two treatment arms (Ozarelix or Goserelin). Elig
patients randomized to the ozarelix group will receive two SC injections of ozarelix 65 mg
abdomen on Day 1 (LLQ and RLQ), followed by a SC injection of 65 mg of Ozarelix (abdo
on day 8 and will receive 2 additional SC injections of Ozarelix on days 28 and 56 (alterna
injection sites). Eligible patients randomized to Goserelin will receive one 3.6 mg SC injec
abdomen (LLQ or RLQ), followed by a 3.6 mg SC injection on Days 28 and 56 (alternating
sites). From India we are recruiting 100 patients , and date of enrollment is 25 Jan 2011 (
anticipated date of enrollment)
Study is conducted in USA and India. The aim of this study is to assess the safety and eff
monthly regimen of ozarelix administered SC versus Goserelin depot administered SC in
Prostate Cancer. This is an international, multi-center, randomized, open label 84 days stu
who are at least 18 years of age or older, with histologically proven prostate cancer of all s
whom endocrine treatment is indicated will be eligible for study entry. Prospective study s
will undergo screening procedures. Approximately 214 eligible patients will enter the study
will be randomized in a 1:1 ratio to one of two treatment arms (Ozarelix or Goserelin). Elig
patients randomized to the ozarelix group will receive two SC injections of ozarelix 65 mg
abdomen on Day 1 (LLQ and RLQ), followed by a SC injection of 65 mg of Ozarelix (abdo
on day 8 and will receive 2 additional SC injections of Ozarelix on days 28 and 56 (alterna
injection sites). Eligible patients randomized to Goserelin will receive one 3.6 mg SC injec
abdomen (LLQ or RLQ), followed by a 3.6 mg SC injection on Days 28 and 56 (alternating
sites). From India we are recruiting 100 patients , and date of enrollment is 25 Jan 2011 (
anticipated date of enrollment)

Last Modified On
Type of Trial
Type of Study
Public Title of Study A study of the range of clinical menifestations and future outcome of acute noncompressiv
myelopathy patients.
Scientific Title of Study of clinical spectrum and outcome of acute noncompressive myelopathies.
Study
NIL

Investigator or overall Name HERAMBA NARAYAN PRAHARAJ
Trial Coordinator
Designation
Affiliation
Address 2/72,BAHAR,SAHARA STATE,JANKIP
RESIDENT,DEPTT OF NEUROLOGY,
Lucknow
UTTAR PRADESH
226020
India
Phone 05223043821
Fax
Email babipraharaj@gmail.com

Person (Scientific Name PROF R.K.GARG
Query)
Designation
Affiliation
Address DM,NEUROLOGY, H.O.D.,DEPTT OF
CHHATRAPATI SAHUJI MAHARAJ ME
,LUCKNOW
Lucknow
UTTAR PRADESH
226003
India
Phone 05222258852
Fax

Person (Public Query) Name PROF R.K.GARG
Designation
Affiliation
Address DM,NEUROLOGY, H.O.D.,DEPTT OF
CSMMU,LUCKNOW
Lucknow
UTTAR PRADESH
226003
India
Phone 05222258852
Fax

Material Support > CHHATRAPATI SAHUJI MAHARAJ MEDICAL UNIVERSITY,LUCKNOW,U.P.,INDIA
Primary Sponsor D
Name NIL
Address
Type of Sponsor

Sponsor nil
Recruitment India
Investigator
PROF R K GARG CSMMU,LUCKNOW,U.
P.,INDIA

Committee
INSTITUTIONAL Approved
ETHICS COMMITTEE

Problems Studied


Age From
Age To
Gender
Details (1) Patients developing acute onset mo
sphincteric disturbance with/without a d
Neurological deficit maximal within 72 h
no progression over 3 weeks. (3) Abse
structural abnormality on MRI.

Details (1)Presence of other known neurologic
radiological signs of involvement of bra
spinal cord. (4)H/O radiation to the spin

Random Sequence
Concealment
MODIFIED RANKIN SCALE AND MODIFIED
BARTHEL ACTIVITY INDEX

contracture,pressure sore,bladder dysfunction

Phase of Trial N/A

Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details
Brief Summary THIS IS A STUDY OF CLINICAL SPECTRUM AND OUTCOME OF ACUTE NONCOMPR
MYELOPATHY PATIENTS.PTS WILL BE ENROLLED AND RECRUITED AS PER
CRITERIAS.INVESTIGATIONS WILL BE DONE TO EXCLUDE COMPRESSIVE ETIOLO
TO ASCERTAIN THE CAUSE.OUTCOME WIL BE MEASURED BY DISABILITY
INDICES(MODIFIED RANKIN SCALE AND MODIFIED BARTHEL ACTIVITY INDEX) ON
ADMISSION AND FOLLOW UP.

Type of Study Drug
Public Title of Study Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Can
Previously Treated With a Docetaxel-containing Regimen
Scientific Title of Multicentre, single-arm, open label, clinical trial intended to provide early access to cabaz
Study patients with metastatic hormone refractory prostate cancer previously treated with a
docetaxel-containing regimen and to document safety of cabazitaxel in these patients
Secondary ID
CABAZ_C_05331
NCT01254279

Investigator or overall Name Dr Ashok Vaid
Trial Coordinator
Designation Oncologist
Affiliation Medanta Cancer Institute,
Address Dept of Medical and Hemato Oncology
Medanta Cancer Institute, Medanta The
Gurgaon- 122001, Haryana, India
Gurgaon
HARYANA
122001
India
Phone 9810212235
Fax
Email Ashok.Vaid@Medanta.org

Person (Scientific Name Dr Deepa Chodankar
Query)
Designation Medical Advisor Clinical Research
Affiliation Sanofi-Aventis
Address 54/A Aventis House, Sir Mathuradas Va
Mumbai
MAHARASHTRA
400093
India
Phone 9096867313
Fax
Email deepa.chodankar@sanofi-aventis.com

Person (Public Query) Name Dr Deepa Chodankar
Designation
Affiliation
Address 54/A Aventis House, Sir Mathuradas Va
Mumbai
Mumbai
MAHARASHTRA
403521
India
Phone 9096867313
Fax
Email deepa.chodankar@sanofi-aventis.com

Material Support > Sanofi-Synthelabo (India) Limited 54/A, Sir Mathuradas Vasanji Road, Andheri (E), Mum
400093

Name SanofiSynthelabo India Limited
Address 54/A Mathuradas Vasanji Road, Andhe

Sponsor
Australia
Austria
Belgium
Canada
Croatia
Czech Republic
Finland
France
Hungary
India
Iran (Islamic Republic of)
Israel
Italy
Luxembourg
Malaysia
Mexico
Philippines
Poland
Portugal
Russian Federation
Singapore
Slovakia
South Africa
Spain
Sweden
Taiwan
United Kingdom

Investigator
Name of Principal Name of Site
Investigator
Dr Francis V James Regional Cancer
Centre, Department of
Radiotherapy and
Oncology
Dr Ramesh B V Apollo Speciality

Nimmagadda Hospital, Department of
Oncology
Dr Ashok Vaid Medanta Cancer

Institute, Dept of
Medical and Hemato
Oncology, Medanta The
Medicity,
Dr Sudhir Rawal Rajiv Gandhi Cancer

Institute & Research
Center, Department of
Urology
Dr N K Mohanty Safdarjang Hospital,

Department of Urology
Dr Tongaonkar Tata Memorial Hospital,

Urology Department

Committee
Name of Committee Approval Status
Dr Tongaonkar -Human Approved

Ethics Committee, Tata
Mamorial Hospital
Dr. Ashok Approved
Vaid-Medanta
Independent Ethics
Committee
Dr. Francis V. Approved

James-Human Ethics
Committee of Regional
Cancer Centre
Dr. N. K. Approved
Mohanty-Ethics
Committee Safdarjung
Hospital
Dr. Ramesh B V Approved

Nimmagadda-Apollo
Hosptitals Enterprise
Limited.
Dr. Sudhir Approved

Rawal-Institutional
Review Board


Patients

Comparator Agent Intervention Cabazitaxel 25 mg/m

Gender Male
Details "Main inclusion criteria: - Age &#8
Metastatic Hormone Refractory Prostat
with a docetaxel-containing regimen - Ea
Group (ECOG) Performance Status (PS
≥3 months - Adequate bon
function: Neutrophils 1500 /mm3; Hemo
x109/L; Bilirubin ULN; SGOT (AST) 1.5
Creatinine 1.5xULN - Signed writt
prior to enrollment " 

Details "Main exclusion criteria:
- Prior radiotherapy to ? 40% of bone m
- Prior radionuclide therapy (samarium-
- Prior surgery, radiation, chemotherap
within 4 weeks prior to enrollment
- Active grade ?2 peripheral neuropathy
- Active grade ?2 stomatitis
- Active infection requiring systemic ant
medication
- Active cancer (other than mHRPC) inc
which the patient has been disease-fre
superficial non-melanoma skin cancer)
- Known brain or leptomeningeal involv
- History of severe hypersensitivity reac
80 containing drugs
to prednisone or prednisolone
- Uncontrolled severe illness or medica
uncontrolled diabetes mellitus)
- Concurrent or planned treatment with
of cytochrome P450 3A4/5 (a one week
necessary for patients who are already
- Participation in a clinical trial with any
- Patient with reproductive potential not

effective method of contraception
"

Random Sequence
Not Applicable
Concealment
To provide early access to cabazitaxel in
patients with metastatic hormone refractory
prostate cancer previously treated with a
docetaxel-containing regimen

To document safety of cabazitaxel in these
patients

Phase of Trial Phase 3/ Phase 4

Enrollment (India)
Enrollment (Global)
Trial Months=6
Days=0
Recruitment Status of Closed to Recruitment of Participants

Trial (Global)
Trial (India)
Publication Details Not yet available
Brief Summary This trial is a multicenter trial. The global First patient in was on 20th December 2010 and
First patient IN in India is 17th June 2011. Trial will be conducted in 28 Countries ARGEN
AUSTRIA, AUSTRALIA, BELGIUM,CANADA, CROATIA, CZECH REPUBLIC, FINLAND,
HUNGARY, INDIA, IRAN, ISRAEL, ITALY, Luxembourg, MALAYSIA, MEXICO, PHILIPPI
POLAND, Portugal, RUSSIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWED
TAIWAN, UK . The Indian target - 13 patients. Indian status - Planned date of first enrolme
June 2011

Type of Study Drug
Public Title of Study Clinical trial of tablet containg two medicines - Dapoxetine and Sildenafil - for the treatmen
co-existing Erectile Dysfunction and Premature Ejaculation.
Scientific Title of Clinical study to evaluate efficacy and safety of Fixed Dose Combination of Dapoxetine
Study Hydrochloride and Sildenafil Citrate Tablet in treatment of co-existing Erectile Dysfunction
Premature Ejaculation.

EPL/2010/DAP-SIL/01; Version 01 dated
20.08.2010

Investigator or overall Name Dr Anand V Tendulkar
Trial Coordinator
Designation Manager - Medical
Affiliation Emcure Pharmaceuticals Ltd,
Address Survey No. 255/2, Phase I, Rajiv Gand
Pune
Pune
MAHARASHTRA
411057
India
Phone 020-39821000
Fax 020-39821019
Email Anand.Tendulkar@emcure.co.in

Person (Scientific Name Dr Anand V Tendulkar
Query)
Pune
Pune
MAHARASHTRA
411057
India
Phone 020-39821000
Fax 020-39821019

Person (Public Query) Name Dr Anand V Tendulkar
Pune
Pune
MAHARASHTRA
411057
India
Phone 020-39821000
Fax 020-39821019

Material Support > Emcure Pharmceuticals Ltd, Pune
Name Emcure Pharmceuticals Ltd Pune
Address Survey No. 255/2, Rajiv Gandhi IT Park
Hinjwadi,Pune-411 057

Sponsor NONE
Recruitment India

Investigator
Dr Rohan Kusumgar Aashray Clinic
MDPsy
Dr Hemang Desai MD Dr. Hemang Desais

DPM Clinic
Dr Vinesh D Prime Hospital

Chandramaniya MBBS
DPM MD
Dr Mrugesh Vaishnav Samvedana Hospital

MDPsy
Dr Ketan Parmar MD Swaminarayan Clinic &

DPM FIPS Nursing Home

Committee
Ethiclin Independent Approved
Ethics Committee for
Dr. Hemang Desai
IBIOME IEC for Dr. Approved
Mrugesh Vaishnav
IEC COMSARTs for Dr. Approved
Ketan Parmar
IEC COMSARTs for Dr. Approved
Vinesh Chandramaniya
Indepndent Ethics Approved
Committee for Dr.
Rohan Kusumgar


Comparator Agent Intervention Fixed dose combination of
Dapoxetine Hydrochloride 30
mg and Sildenafil Citrate 50 mg
Tablet
Comparator Agent Placebo tablet similar to TEST

tablet

Gender Male
Details 1.Male subjects between 18 to 64 year
with stable, monogamous, heterosexua
months and expected/planned to maint
duration of study. 3.Subjects mee
erectile dysfunction (as per the internat
(IIEF) score lesser than or equal to 25;
54: 346-351). 4.Subjects meeting
premature ejaculation (PE score greate
specified in article published in Europea
565-573. 5.Subject and his partne
intercourse 2 times/ week. 6.Sub
informed consent and willing to comply
Exclusion Crite
Details 1.Previous events or other conditions a
ejaculation/erectile dysfunction includin
trauma or pelvic surgery.
2.Subjects with genital anatomical defo
limited to penile deformities.
3.Subjects with erectile dysfunction or p
medication withdrawal.
4.Sexual dysfunction in female partner,
with decreased interest in intercourse o
dysfunction.
5.Subjects with major psychiatric illness
attempts.
6.Subjects with history of epilepsy
7.Subjects with history of stroke, myoca
unstable angina, life-threatening arrhyth
past 6 months.
8.Subjects for whom sexual activity is in
underling disease status.
9.Subject is a known case of autonomic
pigmentosa, bleeding disorders, sickle
ulcer disease.
10.Subjects with significant and uncont
hematological/metabolic/ endocrinologi
eurological/psychiatric/liver/kidney dise
11.Subjects with resting hypotension (B
BP 170/110)
12.Subjects with history of hypersensiti
phosphodiesterase inhibitors and const
13.Subjects with cardiac arrhythmia or
abnormality on ECG.
14.Subjects with previous history of bon
15.Subjects taking concurrent drug the
of discontinuing treatment with : Monoa
(MAOIs), Thioridazine, Selective seroto
selective-norepinephrine reuptake inhib
medicinal/herbal products, tricyclic anti
antipsychotics
16.Subjects taking concurrent treatmen
vosodilators, ketoconazole, itraconazol
telithromycin, nefazadone, nelfinavir, at
erythromycin, clarithromycin, fluconazo
fosamprenavir, aprepitant, verapamil, d
antiplatelet, anticoagulants, dapoxetine
any other recreational drug.
17.Use of other form of therapy (Pharm
erectile dysfunction/ premature ejacula
18.Subjects who will receive some othe
besides that in the protocol that could a
pharmacodynamic profile of the study d
19.Subjects with alcohol or drug abuse
20.Any condition that, in the opinion of
justify the patients inclusion in the study

Random Sequence
Concealment
Blinding/Masking Participant and Investigator Blinded
Responder rate

1) Patient reported outcome measures for
premature ejaculation profile
2) Clinical Global impression for change in
premature ejaculation
3) Improvement in premature ejaculation (PE)
score
4) Improvement in International Index of Erectile
Function (IIEF)
5) Improvement in Sexual Health Inventory for
Male (SHIM)
6) Improvement in qualitative scale for subjective
assessment of Erectile Response published
7) Clinical Global impression for change in
erectile dysfunction
8) Percent of the subjects experiencing any drug

related adverse event as evaluated and recorded
by the investigator
9) Subject’s global assessment about the
tolerability of the drug
10)Physician’s global assessment about the
tolerability of the drug
11) Lab reports & ECG to evaluate any deviation
from normal values


Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details
Brief Summary This multicentric, double-blind, randomized, clinical trial is planned to evaluate efficacy an
Fixed Dose Combination of Dapoxetine Hydrochloride and Sildenafil Citrate Tablet in trea
co-existing Erectile Dysfunction and Premature Ejaculation. Subjects satisfing inclusion an
exclusion criteria will be randomized to 3:1 ratio to study and reference group respectively
laboratory investigations and ECG will be done. Subjects will be evaluated for primary and
seconady efficacy variables at basline, after 2 weeks and after 4 weeks of therapy. Labora
investigations and ECG will be done after 4 weeks of therapy.
This multicentric, double-blind, randomized, clinical trial is planned to evaluate efficacy an
Fixed Dose Combination of Dapoxetine Hydrochloride and Sildenafil Citrate Tablet in trea
co-existing Erectile Dysfunction and Premature Ejaculation. Subjects satisfing inclusion an
exclusion criteria will be randomized to 3:1 ratio to study and reference group respectively
laboratory investigations and ECG will be done. Subjects will be evaluated for primary and
seconady efficacy variables at basline, after 2 weeks and after 4 weeks of therapy. Labora
investigations and ECG will be done after 4 weeks of therapy.

Type of Study Drug
Public Title of Study A Clinical Trial to evaluate the safety and Tolerability of Treatment in Adolscent patients w
Schizophrenia.
Scientific Title of A Long-term, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Fle
Study Oral Aripiprazole (OPC- 14597) as Maintenance Treatment in Adolescent Patients with
Schizophrenia or Child and Adolescent Patients with Bipolar I Disorder, Manic or Mixed E
with or without Psychotic Features

31-09-267 Amendment 3 dated 28 Mar 2011
NCT01122927
Details of Principal Inv
Trial Coordinator
Designation
Affiliation
Address
Phone
Fax
Email

Person (Scientific Name Mr Ulhas Shinde
Query)
Designation Senior Manager, Clinical Operations
Affiliation Covance India Pharmaceutical Service
Address Covance India Pharmaceutical Service
15th Floor, Dev Corpora, Pokhran Roa
Highway, Opposite Cadburys,Thane, M
400601
Mumbai
MAHARASHTRA
400601
India
Phone 91-22-42284822
Fax 91-22-42284952
Email ulhas.shinde@covance.com

Person (Public Query) Name Mr Ulhas Shinde
Designation Senior Manager-Clinical Operations Ind
Affiliation Covance India Pharmaceutical Pvt. Ltd
Address Unit No. 1017, Trade Centre Bandra-Ku
Mumbai
MAHARASHTRA
400051
India
Phone 91-22-40700462
Fax 91-22-40700665
Email ulhas.shinde@covance.com

Material Support > Otsuka Pharmaceutical Development & Commercialization, Inc. 2440 Research Bouleva
Rockville, Maryland 20850 United States

Name Otsuka Pharmaceutical Development a
Address 2440 Research Boulevard Rockville Ma

Sponsor Covance India Pharmaceutical Services Pvt Ltd

Recruitment Australia
Bulgaria
China
Germany
India
Philippines
Thailand
United Kingdom

Investigator
Dr Smiriti Chhabra A.J.Institute of Medical
Sciences
Dr Ramanand Brain Mind Behaviour

Satapathy Neurosciences
Research Institute
Dr Sandeep Shah Brij Psychiatry Hospital
Dr Sunil Mittal Cosmos Hospital &

PDF of Trial
CTRI Website
Research Centre Centre,,35,Defence

Enclave, Vikas
Marg-110092
New Delhi
DELHI
Dr Navkiran Mahajan Dayanand Medical Department of
College & Hospital Psychiatry, Tagore
(DMCH) Nagar,Civil
Lines-141001
Ludhiana
PUNJAB
Dr Sanjay Phadke Deenanath Mangeshkar Neuropsychiatry

Hospital & Research Department, Erandwan
Centre e,Pune-411004
Pune
MAHARASHTRA
Dr Satyanarayan Rao JSS Medical College Department of

and Hospital Psychiatry Ramanuja
Road,-570004
Mysore
KARNATAKA
Dr Ramesh Kumar Mahendru Psychiatry Psychiatry Department,

Mahendru Centre 117/40, ,Sarvodaya
Nagar,Kanpur -208005
Not Applicable
N/A
Dr Ravish Thunga Manaswani Thunga Department of

Institute of Psychiatry & Psychiatry Jyothi Circle,
Counselling Balamatta-575001
Bangalore
KARNATAKA
Dr Anil Tambi Mental Health Care & Department of

Research Psychiatry, A-500,
Govind Marg,,Malaviya
Nagar-302017
Jaipur
RAJASTHAN
Dr Mahesh Chudgar Mental Illness Department of
Treatment Psychiatry,(MITR
Rehabilitation Foundation), 1, Shanti
Foundation Nagar Society, Way of
Azad Sweet, Ashram
Road, Ahmedabad -
380013 India.
Ahmadabad
GUJARAT
Dr Hitendra Gandhi Sheth V.S.Hospital Room No.- 14, Arogya

Bhuvan, Department of
Psychiatry, Ellisbridge
Ahmadabad
GUJARAT
Dr Lakshman Shri Krishna Prasad 111, Shriji Complex,

Shankarlal Dutt Psychiatric Nursing Behind V.S.Hospital,,Ell
Home & Research isbridge, -380006
Centre Ahmadabad
GUJARAT
Dr JMWadhwan Sir Ganga Ram Sir Ganga Ram

Hospital Hospital Dept. of
Dr BSV Prasad Sujata Birla Hospital &

medical research center

Committee
Committee [DTEC], Dr.
Navkiran Mahajan
A.J.Ethics Committee Approved
Medical Sciences Dr.
Smriti Chhabra
Cosmos Independent Approved
Ethics Committee Dr.
Sunil Mittal
Ethical Committee, Approved
Sheth V.S.Hospital Dr.
Hitendra Gandhi
Ethics Committee JSS Approved
Medical College Dr.
TSS Rao
Ethics Committee MITR Approved
Foundation, Dr.
Mahesh Chudgar
Ethics Committee Sir Approved
Ganga Ram Hospital
Dr. J.M.Wadhwan
Independent Ethics Approved
Committee Mental
Health Care and
Research Dr. Anil
Tambi
Institutional Ethic Approved

Committee King
George Hospital Dr.
Ramanand Satapathy

Committee Deenanath
Mangeshkar Hospital &
Research Centre Dr.
Sanjay Phadke
Kanpur Medical Ethics Approved

Committee Dr. Ramesh
Kumar Mahendru
Mallikatta Ethical Approved
Committee Dr. Ravish
Thunga
National Ethics Approved
Committee Dr.
Lakshman Dutt
North Maharahtra Approved
Ethics Committee Dr
BSV Prasad
SUMANDEEP Approved
VIDYAPEETH
INSTITUTIONAL
ETHICS COMMITTEE

Comparator Agent Intervention Aripiprazole

Gender Both
Details 1) Study specific written informed cons
a legally acceptable representative (eg
initiation of any protocol-required proce
subject must provide informed assent a
must be able to understand that he or<
the study at any time. All informed 
must be in accordance with the st
review board/ethics committee (IR
requirements. If the roll-over subje
age within 4 weeks prior to entry i
267 participation, an informed con
from the subject. 2) Adolesce
including: ? De novo subjects age
(ie, subject must have passed his
not yet reached their 17th birthday at th
PDF of Trial
informed consent/assent) ? Rollover subjects from Study

266 3) Subjects with a current diagnosis of schizophrenia,
as defined by DSM-IV-TR criteria (and confirmed by the
K-SADS-PL for de novo subjects only), and a history of the
illness (diagnosis or symptoms) for at least 6 months prior to
screening (as per subject, family, or healthcare provider, or by
previous medical records). Schizophrenia must be the primary
DSM-IV-TR axis I diagnosis. The diagnosis of schizophrenia
must be made and documented initially by an adequately
trained clinician (eg, adolescent psychiatrist or local medical
equivalent). For de novo subjects, the diagnosis should be
confirmed by utilizing the K-SADS-PL performed by an
adequately trained clinician once at the time of the entry into
Study 267. Rollover subjects could use K-SADS-PL collected
during Study 266. 4) Subjects who, in the investigator?s
judgment, require treatment with antipsychotic
medication(s). 5) Subjects who have shown previous response
to antipsychotic treatment (other than clozapine unless 
clozapine is the only available treatment) and are not resistant
to treatment with other antipsychotics, according to the
investigator?s clinical judgment. 6) Subjects who are currently
being treated with oral or depot antipsychotics other than
clozapine, unless clozapine is the only available treatment and
subjects are not resistant to treatment with other antipsychotics.
De novo subjects who recently have been without antipsychotic
treatment (for no more than 3 weeks) prior to screening will be
considered as being treated currently for the purpose of
determining eligibility for this trial. 7) Inpatient or outpatient
status, with the exception of acute hospitalization due to
psychiatric reasons at the time of screening or before Phase
2. 8) Ability of the subject and the subject?s legally
acceptable representative (eg, guardian) or caregiver(s) to
comprehend and satisfactorily comply with the protocol
requirements (including the prescribed dosage regimens, tablet
ingestion, and discontinuation of prohibited concomitant 
medications), to read and understand the written word in order
to complete subject-reported outcomes measures, and to
reliably rate assessment scales. 9) Females of childbearing
potential must have a negative pregnancy test, must be
practicing acceptable double barrier methods of contraception
(or can confirm abstinence), and must not be pregnant or
lactating. 10) Subjects who are receiving antipsychotic(s) other
than aripiprazole or clozapine (unless clozapine is the only 
available antipsychotic agent and the subject is not resistant to
other antipsychotic treatment) must be cross-titrated to study
aripiprazole monotherapy over 4 to 6 weeks using an initial
dose of 2 mg/day in Phase 1 to achieve a recommended
aripiprazole monotherapy minimum target dose of 10 mg/day in
order to enter Phase 2, but higher doses may be achieved
based on the subject?s clinical need and investigator (see
Table 3.2.1-1). 11) Subjects who are treated with non-branded
generic aripiprazole must also be cross-titrated to achieve
a 10 mg/day target dose of study aripiprazole (see Table
3.2.1-2). Also, the total dose of the generic aripiprazole and
study aripiprazole (at any given time in Phase 1) cannot exceed
a total of 30 mg/day. 12) By the end of screening, eligible
subjects who are receiving oral branded aripiprazole (ie,
Abilify) monotherapy at a dose of 10 to 30 mg/day for
treatment of schizophrenia at screening can enter Phase 2
directly. Subjects who are currently receiving branded
aripiprazole (ie, Abilify) monotherapy at a dose of 5 to
page 6 / 8
10 mg/day, after successfully com

Phase 2 directly (bypassing Phas
they are currently receiving and st
minimum 10 mg/day dose during
2. 13) Adequate washout of prohib
medications prior to entry into Pha
days for mood stabilizers, &#8805
≥ 1 cycle plus 14 days for m
antipsychotics (eg, 2-week cycle p
risperidone long-acting injection),
screening for investigational long-
(see Table 4.1-1). 14) Subje
than 1 benzodiazepine after scree
receiving 2 benzodiazepines at sc
made to discontinue 1 of them, if c
allow potential subjects to enter th
benzodiazepine should be tapered off o
amount of time within the established d
period to prevent any withdrawal effect
be maintained on the remaining b
days prior to the first dose of study med

Details 1) Sexually active males who are not p
control or who will not remain abstinent
days following the last dose of study m
females of
childbearing potential who are not prac
control or who will not remain abstinent
days following the last dose of study m
permitted if it is
confirmed and documented at every stu
employing birth control, 2 of the followin
vasectomy, tubal ligation, vaginal diaph
(IUD), birth control pill,implant, condom
2) Females who are breast-feeding and
serum pregnancy test result prior to rec
Disease
3) Patients with and Axis I (DSM-IV-TR
disorder, or a current diagnosis of majo
4) Subjects with a clinical presentation
consistent with delirium, dementia, amn
disorders; subjects with psychotic symp
are better accounted for by another gen
direct effect of a substance (ie, medica
5) Any neurological disorder, with the e
syndrome.
6) Subjects experiencing acute depress
30 days prior to screening that require
antidepressant, according to the invest
judgment.
7) Subjects with schizophrenia that is C
resistant to antipsychotic medication, in
adequate doses of aripiprazole, by hist
8) Subjects with a history of failure of c
response to clozapine treatment only.

Random Sequence
Method of On-site computer system
Concealment

The frequency and severity of AEs, SAEs
(clinical and laboratory), and discontinuation
from study due to AEs

Mean change from baseline and incidence of
clinically significant
abnormalities in clinical laboratory tests and
urinalysis results (including
fasting blood lipids, glucose and insulin, serum
prolactin, hemoglobin A1c
[HbA1c] and creatinine phosphokinase [CPK]),
vital signs (supine and
standing positions) and ECG parameters. A
central ECG service will be
utilized to review all ECGs in order to
standardize interpretations for the
safety analysis
• Review of physical examination findings


Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details No Publication yet
Brief Summary This Study is to evaluate the safety and tolerability of flexible oral dose of oral Aripiprazole
Adolscent patient with schizophrenia

Type of Trial Observational
Type of Study Follow Up Study
Study Design Other
Public Title of Study Study of prevalence of bladder dysfunction and urodynamic findings in Guillain-Barre synd
their correlation with outcome
Scientific Title of study of prevalence of bladder dysfunction and urodynamic findings in Guillain-Barre synd
Study their correlation with outcome
NIL

Investigator or overall Name PRAVIN NAPHADE
Trial Coordinator
Designation SENIOR RESIDENT, NEUROLOGY
Affiliation
Address DEPARTMENT OF NEUROLOGY, CS
UNIVERSITY(KGMC), CHOWK, LUCK
Lucknow
UTTAR PRADESH
622001
India
Phone 05222258852
Fax 05222258852
Email pravin_naphade@yahoo.com

Person (Scientific Name PROF R K GARG
Query)
Designation professor and head
Affiliation
Address DEPTT OF NEUROLOGY, CSMMU (K
Lucknow
UTTAR PRADESH
622001
India
Phone 05222258852
Fax 05222258852

Person (Public Query) Name PROF R K GARG
Designation professor and head
Affiliation
Address DEPTT OF NEUROLOGY, CSMMU (K
Lucknow
UTTAR PRADESH
622001
India
Phone 05222258852
Fax 05222258852

Material Support > CSM MEDICAL UNIVERSITY, LUCKNOW
Name CSM MEDICAL UNIVERSITY LUCKNO
Address KG MEDICAL COLLEGE LUCKNOW.
Type of Sponsor Government medical college

Sponsor NIL
Recruitment India

Investigator
PROF R K GARG DEPARTMENT OF
NEUROLOGY

Committee
CSM MEDICAL Approved
UNIVERSITY ETHIC
COMMITTEE

Comparator Agent
Gender Both
Details Patients with clinical and electrophysiol
Barre syndrome according to Asburys a

Details Patients having other causes of bladde
Patients on mechanical ventilation
Method of Generating
Random Sequence
Method of
Concealment
Hughes motor grade,overall disability sum score,
medical research council sum score

DEATH

Phase of Trial N/A

Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details
Brief Summary urinary involvement is not considered as feature of Guillain Barre syndrome. But as auton
nervous system involvement is known and urinary bladder is supplied by this, it is expecte
involved. We will follow patients of GBS for urinary involvement and will assess them
urodynamically. We will correlate urodynamic findings with disability.

Type of Study Drug
Biological
Single Arm Study
Public Title of Study A clinical trial to evaluate efficacy and safety of R-TPR-004 in patients with acute ischemic
Scientific Title of A Prospective, multi-centric, single-arm, clinical study to evaluate efficacy and safety of R
Study in patients undergoing treatment for acute ischemic stroke
RLS/TP/2010/03, Ver 2.0, dated 03/10/2012

Investigator or overall Name Dr Parvez Kosgi
Trial Coordinator
Designation Head RLS clinical Trial
Affiliation Reliance Life Sciences Pvt.Ltd
Address Dhirubhai Ambani Life Sciences Centre
Rabale Navi Mumbai
Thane
MAHARASHTRA
400701
India
Phone 02240678000
Fax 02240678299
Email parvez.kosgi@relbio.com

Person (Scientific Name Dr Devi Manjula
Query)
Designation Head clinical Pharmacology
Affiliation Reliance Life Sciences Pvt Ltd
Address Reliance Clinical Research Services, R
Ltd. CPR TOWERS, # 65-373-2, 100 ft
Stage
Bangalore
KARNATAKA
560 076
India
Phone 08066261116
Fax 08066261196
Email Devi.Manjula@Relbio.com

Person (Public Query) Name Dr Parvez Kosgi
Designation Head - RLS Trials
Affiliation
Address Reliance Life Sciences Pvt. Ltd., Dhirub
Centre, Plot R-282 TTC Area of MIDC,
Thane
MAHARASHTRA
400 701
India
Phone 022-6767-8258
Fax 02267678299
Email parvez.kosgi@relclin.com

Material Support > Reliance Life sciences Pvt. Ltd. Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC
MIDC Thane Belapur Road, Rabale, Navi Mumbai 400 701

Name Reliance Life Sciences Pvt Ltd
Address Dhirubhai Ambani Life Sciences Centre
Thane Belapur Road Rabale Navi Mum

Sponsor NIL
Recruitment India
Investigator
Dr Yashpal Singh Christian Medical
College and hospital
Dr Bashir Ahmadi H C G -Medi-Surge

Hospital
Dr B S Keshava JSS Medical College

Hospital
Dr Ravishankar Naik KLES Dr. Prabhakar

Kore Hospital
Dr P Vijaya Lalitha Super

Specialities Hospital
Pvt. Ltd
Dr R Srinivasa M.S. Ramaiah
Memorial Hospital
Dr Anshu Rohatgi Sir Ganga Ram

Hospital
Dr Gosala Sarma St. Johns Medical

college
Dr Vikram Sharma St. Theresa’s General

Hospital
Dr Rahul Chakor T N M C & BYL Nair

Charitable Hospital

Committee
Ethical Review Board Approved
M.S. Ramaiah Medical
College & Teaching
Hospital Bangalore
Ethics Committee BYL Approved

Nair Charitable Hospital
& T N Medical College
Mumbai
Ethics Committee Of Approved

KLE University
Belgaum
Ethics Committee St. Approved
Theresa’s General
Hospital Hyderabad
Ethics Committee, HCG Submittted/Under
Medi-Surge Hospital Review
Ahmedabad
Ludhiana
Ethics Committee, Sir Submittted/Under
Ganga Ram Hospital Review
Institutional Ethical Approved
Review Board St. Johns
Medical College &
Hospital Bangalore
Institutional Ethics Submittted/Under

Committee Of JSS Review
Medical College Mysore
Lalitha Super Approved
Specialities Ethics
Committee


Comparator Agent Intervention Tissue plasminogen activator
named as R-TPR-004
Comparator Agent Not Applicable

Gender Both
Details 1. Patient with Ischemic Stroke of 4.5 h
2. Patients with normal or slight early C
stroke. 3. Women of child bearing
pregnancy test and taking adequate bir
Consent from Legally Acceptable Repr
not in the condition to give consent. Ho
stable and is able to give consent, cons
separate ICF to confirm his/her willingn
study. 

Details 1. Patient with h/o Recent Stroke 110 m
arm cuff readings over 20-30 minutes),
antihypertensive therapy or requiring ni
6. Presence or h/o intracranial neoplas
malformation, intracranial aneurysm, un
months.
7. Major surgery, serious trauma, lumb
at a non-compressible site, or biopsy o
14 days. (Major surgical procedures inc
following: major thoracic or abdominop
major limb surgery, carotid endarterect
surgery, and organ transplant).
8. Medical history or evidence of HIV, H
9. Subject participation in another clinic
administration of IP.
10. Pregnant and lactating females.
11. Any other condition which investiga
significant hazard to
subject if IP is administered.

Random Sequence
Concealment
To assess the efficacy of R-TPR-004 in patients
with Acute Ischemic Stroke
Assessment of disability by modified Rankin

Scale (mRs) scores
Assessment of safety
Assessment of disability by modified Rankin
Scale (mRs) scores
Assessment of safety


Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details Not Applicable
Brief Summary Based on the available data trends, RLS decided that it is not feasible to c
with the study on clinical grounds at the currently prescribed dose

Type of Study Drug
Public Title of Study Clinical Study of Eslicarbazepine Acetate as a Therapy in Post-Herpetic Neuralgia. (Post-
neuralgia is a chronic pain syndrome following an acute infection of herpes zoster (shingle
Clinical Study of Eslicarbazepine Acetate as a Therapy in Post-Herpetic Neuralgia. (Post-
neuralgia is a chronic pain syndrome following an acute infection of herpes zoster (shingle
Scientific Title of A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter C
Study Study of Eslicarbazepine Acetate in Post-Herpetic Neuralgia.
BIA-2093-308
NCT01124097

Trial Coordinator
Designation
Affiliation
Address
Phone
Fax
Email

Person (Scientific Name Arun Sundriyal
Query)
Designation Associate Director
Affiliation
Address PPD Pharmaceutical Development (I) P
floor Sector 25, Mehrauli Gurgaon Roa
Gurgaon
HARYANA
122002
India
Phone 91-124-4739903
Fax 91-124-4739999

Person (Public Query) Name Arun Sundriyal
Designation Associate Director
Affiliation
11th floor Sector 25, Mehrauli Gurgaon
Gurgaon
HARYANA
122002
India
Phone 91-124-4739903
Fax 91-124-4739999

Material Support > Bial - Portela C S.A. À Avenida da Siderurgia Nacional, Apartado 19, 4745-457 S. Mam
Coronado, Portugal

Name Bial Portela C SA
Address Avenida da Siderurgia Nacional, Aparta
do Coronado, Portugal

Sponsor PPD

Austria
Chile
Germany
India
Israel
Mexico
Poland
Russian Federation
South Africa
Spain
United Kingdom

Investigator
Dr. Krishnan Vijayan Koval Medical Center
and Hospital Ltd.
Dr. Suresh Kumar Vijaya Health Centre,

Dr. M M Mehndiratta G. B. Pant Hospital,
Dr. Sandeep Kumar M.V. Hospital and

Gupta Research Centre,
Dr. Varadarajulu Bangalore Clinisearch,

Reginald
Dr. Bhawna Sharma Sawai Man Singh

Medical College
Hospital
Dr. Deepak Dewan Ajanta Hospital & IVF

Centre,

Committee
Bangalore Central Approved
Ethics Committee
Bio Ethics Forum Approved
Committee for M.V.
Hospital & Research
Centre
KMCH Ethics Approved

Committee
The Ethics Committee, Approved
Vijay Health Centre
The Institutional Ethics Approved
Committee of SMS
Medical College
The Institutional Ethics Approved
Committee, Maulana
Azad Medical College
and Associated Lok
Nayak G B Pant
Hospital,

Comparator Agent Intervention Eslicarbazepine acetate 800 mg
once daily (QD)(Oral Tablets)
Intervention Eslicarbazepine acetate 1200

mg QD (Oral tablets)
Intervention Eslicarbazepine acetate 1600

mg QD (Oral Tablets)
Comparator Agent Placebo: Placebo Comparator

(Oral Tablets)

Gender Both
Details 1. Male and female outpatients aged 18
subjects are of nonchildbearing potenti
sterilization (hysterectomy or bilateral o
or at least 2 years postmenopausal (sp
least 24 months before Visit 1), or if of
subjects agree to use a medically acce
of contraception. 2. Experiencing
after the healing of a herpes zoster skin
between 4.0 and 9.0, inclusive, on the 2
assessment. 4. Compliance with
 5. If not used to treat PHN, subje
nonsteroidal anti inflammatory drugs an
reuptake inhibitors if they were kept on
prior to Screening and are foreseen to
study. 6. Competent and able to f
consent. 7. Female subjects of ch
not currently breastfeeding, must have
test at Visit 1. Note: There is no u
inclusion or exclusion in the study.

Details 1. Historical exposure to drugs known t
2. Significant skin lesions (active infecti
3. Known intolerance to ESL or to othe
carbamazepine or oxcarbazepine) or fr
reactions with multiple medications.
4. Subjects who previously participated
5. Major psychiatric disorder.
6. Serious or unstable cardiovascular d
participation or cause hospitalization du
7. Second or third degree atrioventricul
a pacemaker or any clinically significan
electrocardiogram as determined by the
8. Subjects taking the following drug cla
excluded: benzodiazepines (except sho
skeletal muscle relaxants, orally admin
mexiletine, centrally acting analgesics (
opiates, topical lidocaine, anticonvulsan
and serotonin norepinephrine reuptake
require a minimum washout period of a
should be tapered appropriately using p
guide.
9. Relevant clinical laboratory abnorma
opinion, can compromise the subjects s
10. History of drug abuse or dependenc
DSM IV) within the past year, excluding
11. Subjects who, in the previous 30 da
drug that had not received regulatory a
the time of study entry.
12. History of recurrent epileptic seizure
13. History of severe gastroparesis or g
14. Neurolytic or neurosurgical treatme
15. Injected anesthetics or steroid use
16. Malignancy within past 2 years.
17. History of chronic hepatitis B or C w
human immunodeficiency virus infectio
Random Sequence
Concealment
Blinding/Masking Participant, Investigator and Outcome Assessor Blinded
To assess the efficacy of ESL as therapy in
subjects with Post Herpetic Neuralgia

Weekly mean pain intensity (calculated from the
11-point NRPS).
Responder rates (reduction of at least 30% or at
least 50% compared with baseline based on the
11-point NRPS average pain score).
Time to response (time in days to the first of 2
consecutive days after randomization with
average pain score at least 2 points below
baseline mean pain, based on the 11-point
NRPS average pain score).
Patient and clinical global impression of change

(subjects rate their change in the overall status
answering the question on the scale).
Short Form McGill Pain Questionnaire (subjects
complete this questionnaire as a qualitative
assessment of their pain and their affective
response to pain).
Allodynia Visual Analog Scale (subjects rate the

allodynia severity after mechanic allodynia
evoked pain).
Chronic Pain Sleep Inventory (subjects complete
this inventory to assess the impact of their pain
on sleep).
Rescue medication use (number of days from
first intake of double-blind study drug to first
intake of rescue medication and the mean
amount of paracetamol per study day will be
derived).
Worst daily pain and worst night pain (change
from Baseline to endpoint in worst daily pain and
night pain is defined in the same way as the
primary efficacy endpoint).


Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0
Trial (Global)
Trial (India)
Publication Details
Brief Summary Post-herpetic neuralgia (PHN) is a syndrome of intractable pain following an acute infectio
herpes zoster (shingles). Treatment for PHN is often suboptimal. More than 50% of the su
to respond to pharmacological treatments or experience intolerable side effects. The clinic
development of ESL to treat neuropathic pain is based on its chemical and pharmacodyna
relationship to sodium channel blockers, including carbamazepine, which is effective for tr
some neuropathic pain conditions. Preclinical data supports the theoretical background. T
will examine the efficacy, safety, tolerability and pharmacokinetics of Eslicarbazepine ace
treatment of post herpetic neuralgia. The present study will investigate the effect of 3 ESL
(800, 1200, or 1600 mg OD) in subjects with PHN compared with placebo.
Type of Study Drug
Public Title of Study A global study testing efficacy and safety of Phenobarbital in patients with partial seizures
Scientific Title of An international, double-blind, parallel-group, placebo-controlled, randomized study: evalu
Study the efficacy and safety of phenobarbital as adjunctive therapy in participants (? 17 to 70 y
with partial onset seizures.

AGG-901
NCT01284556
U1111-1119-3936

Investigator or overall Name Dr R Varadarajulu
Trial Coordinator
Designation Senior Consultant-Neurology
Affiliation
Address Dr. R. Varadarajulu No 416, 4th Cross,
Bangalore Karnataka - 560 043 India N
Kalyan Nagar
Bangalore
KARNATAKA
560 043
India
Phone 91-9880101778
Fax 91-80-41791001
Email varadarajuludr@gmail.com

Person (Scientific Name Dr Atul Gupta
Query)
Designation Medical Monitor
Affiliation Max Neeman International Ltd.
Address Max Neeman International Ltd. Max Ho
Marg, Okhla - III
New Delhi
DELHI
110 020
India
Phone 91-9717287654
Fax 91-11-41001945
Email atulg@neemanasia.com

Person (Public Query) Name Dr Shariq Anwar
Designation Director Operations
Affiliation
Address Max Neeman International Ltd. Max Ho
Marg, Okhla - III New Delhi - 110 020 M
Okhla Phase III
New Delhi
DELHI
110020
India
Phone 9810979215
Fax 91-80-41791001
Email sanwar@neemanasia.com

Material Support > West-ward Pharmaceutical Corporation 465 Industrial Way West Eatontown, NJ 07724,

Name Zaidoon A AlZubaidy Vice President Op
Address RRI Group, Inc. 248 Latitude Lane, Sui
29710-1457 Phone: 803-831-1457 Cell
Fax:803-831-1494
Type of Sponsor Contract research organization

Sponsor Max Neeman International

Recruitment Bulgaria
India

Investigator
Dr Kiran Kumar Adhit Kiran
Neuropsychiatry centre
Dr S C Mukherjee B.P. Poddar Hospital&

Medical Resarch lab
Dr Varadarajulu Bangalore Clinisearch

Reginald
Dr Suresh Gaikwad Dr. Gaikwad’s Critical
PDF of Trial
CTRI Website
Care Centre Care Centre 31,

Reshimbag,
Sakkardara Square,
Umrer Road, Pin Code
-440009
Nagpur
MAHARASHTRA
Dr Prafulla K Getwell & Hospital Getwell & Hospital

Shembalkar Research Institute Research Institute,20/1,
Dr. Khare Marg,
Dhantoli,-440012
Nagpur
MAHARASHTRA
Dr Santhosh Kumar K.R.Hospital K.R. Hospital,K.R.
Hospital, No 979, 25th
Main Road, BSK 1st
stage, Opp PES Colg,
Hanumanth
Nagar,Bangalore-560
050,Karnataka,India
Bangalore
KARNATAKA
Dr Devdutt Deshmukh Kamalnayan Bajaj Kamalnayan Bajaj

Hospital Hospital Gut No-43,
Beed Bypass road,
Bajaj Marg, Satara
Parisar, Pin Code
-431005
Aurangabad
MAHARASHTRA
Dr Madhusudhan Babu King George Hospital Address Line 1: King

George Hospital,
Address Line 2: Near
Collectorate, City:
Vishakhapatnam State:
Andhra Pradesh Postal
Code: 530002 Country:
India
Visakhapatnam
ANDHRA PRADESH
Dr Jayanti Mani Kokilaben Dhirubhai Address Line 1:

Ambani Hospital & Kokilaben Dhirubhai
Medicine Research Ambani Hospital &
Institute Medicine Research
Institute, Address Line
2: Department of
Neurology, Four
Bungalows, City:
Andheri, Mumbai State:
Maharashtra Postal
Code: 400053 Country:
India
Mumbai
MAHARASHTRA
Dr R Srinivasa M S Ramaiah Memorial M S Ramaiah Memorial

Hospital Hospital, New B E L
Road, M S Ramaiah
Nagar, MSRIT Post,
Bangalore-560
054,Karnataka, India
PDF of Trial
CTRI Website
Bangalore
KARNATAKA
Dr Neeta Garg M.V. Hospital & 314/30, Mirza Mandi
Research Centre Chowk,Lucknow,Uttar
Pradesh
Lucknow
UTTAR PRADESH
Dr Shankar Nellikunja Mallikatta Neuro Center Opp. Mallikatta circle,

Kadri,Mallikatta,
Mangalore,Karnataka
575002, India
Mysore
KARNATAKA
Dr Rahul Kulkarni Mangeshkar Hospital & Mangeshkar Hospital &

Research Center Research Center Erand
wane,Pune.Maharashtr
a
Pune
MAHARASHTRA
Dr Puneet Agarwal Max Institute of Max Institute of

Neurosciences, Max Neurosciences, Max
Super Specialty Super Specialty
Hospital Hospital, 1 Press
Enclave Road, Saket,
City: New Delhi State:
New Delhi-110017
Country: India
South
DELHI
Dr Amlan Mandal Medica Hospitals Pvt. Address Line 1: Medica

Ltd Hospitals Pvt. Ltd.
Address Line 2: 127,
Mukundapur, E. M.
Bypass,, City: Kolkata
State: West Bengal
Postal Code: 700099
Country: India
Kolkata
WEST BENGAL
Dr Shalin D Shah Neurology Centre Neurology

Centre,206-08 Sangini
Complex, Nr. Parimal
Crossing, Ellisbridge,
Ahmedabad-
380006,Gujrat
Ahmadabad
GUJARAT
Dr Nithin Kumar N PACE Clinical Address Line 1: PACE
Research Clinical Research,
Address Line 2: No. 53,
Nanda Complex,
Ramamurthy Nagar
Main Road, Banaswadi,
City: Bangalore State:
Karnataka Postal Code:
560050 Country: India
Bangalore
KARNATAKA
Dr Rajnish Kumar Paras Hospital Paras Hospital, C-1
Dr K Ramadoss PSG Hospitals
Dr R S Wadia Ruby Hall Clinic
Dr Anand Diwan Shatabdi Super

speciality Hospital
Dr G R K Sarma St Johns Medical

College Hospital
Dr Bhavin Pujara Vedant Multi Speciality
Hospital & Research
Centre

Committee
B.P. Poddar Hospital & Approved
Medical Research Ltd.
Ethics Committee
Bangalore Clinisearch, Approved
Bangalore - Bangalore
Central Ethics
Committee
Canara Research Approved

Ethical Committee
Deenanath Mangeshkar Approved
Hospital & Research
Center, Institutional
Ethics Committee
ETHICOS Independent Approved

Ethics Committee Flat
PDF of Trial
CTRI Website
No-302,Tower-1,Flower
Valley Opp.Cadbury
Factory Estern Express
Highway Thane
(west)-400601
Getwell Hospital & Approved 25/10/2010
Research Center,
Nagpur - Global Health
Concern Ethics
Committee
Institutional Ethics Approved 08/11/2010

Committee (IEC), M.V.
Hospital & Research
Centre
K.R. Hospital, Approved 05/10/2010
Bangalore Central
Ethics Committee
Kamalnayan Bajaj Approved 21/03/2012
Hospital Gut No-43,
Beed Bypass road,
Bajaj Marg, Satara
Parisar,
Aurangabad-431005
King George Hospital, Approved 02/12/2010

Institutional Ethics
Committee
Kokilaben Dhirubhai Approved 14/12/2010
Ambani Hospital &
Medicine Research
Institute
M.S. Ramaiah Medical Approved 19/11/2010

Medical College and
Teaching Hospital,
Ethical Review Board
Mallikatta Neuro Approved 30/10/2010

Center, Mangalore -
Mallikatta Ethical
Committee
Max Super Specialty Approved 27/05/2011

Hospital Max
Healthcare Ethics
Committe
Medica Hospital Ethics Approved 31/01/2011

Committee
Nagpur Independent Approved 09/03/2012
Ethics Committee,
Nagpur
Admin.Office-303,NIT
Lay out Trimurti
Nagar-440010
Neurology Center, Approved 30/10/2010

Ahemdabad - Sujlam
Independent Ethics
Committee
PACE Clinical Approved 05/10/2010

Research Centre,
Bangalore Central
Ethics Committee
Paras Hospital Ethics Approved
Committee
PSG Institute of Approved
Medical Sciences &
Research, Institutional
Human Ethics
Committee
Ruby Hall Clinic, Pune - Approved

Poona Medical
Research Foundation
Shatabdi Hospital Approved
Ethics Committee
Suyojit City Centre,
Opp Mahamarg Bus
Stand, Mumbai Naka,
Nashik – 422005,
Maharashtra, India
St. Johns Medical Approved

College & Hospital,
Institutional Ethical
Review Board



Comparator Agent Intervention Tab. Phenobarbital

Gender Both
Details Inclusion Criteria: 1) Participants from 1
(inclusive); 2) Participants with a h
seizures (complex or simple[with motor
ILAE classification; 1981)whether or no
generalized; 3) Participants must
years, one electroencephalogram (EEG
brain magnetic resonance imaging (MR
tomography (CT) with results consisten
partial-onset seizures. If these have no
10 years, or if the records of these are
or MRI will be performed as part of the
4) Participants having at least eight Typ

whether or not secondarily generalized
Period; 5) Participants being uncontroll
permitted concomitant AED(s) and/or V
participant is treated with VNS for at lea
of the study, this will count as one of th
treatments); 6) Participant has be
current anti-epileptic treatment regime
screening and VNS settings must have
1 month

Details Exclusion Criteria
1)Currently taking phenobarbital or prim
been off for a month prior to study scre
2) Currently taking felbamate or vigaba
medication excluded except those appr
the United States.
3) History of prior allergic reaction to ph
4) History or presence of seizures occu
frequently or indistinctly separated to b
3; 5) History or presence of status epile
preceding Visit 1 or during baseline;
6) History of psychogenic seizures;
7)Participant taking any drug with poss
except if stable from at least 1 month b
be kept stable during the Treatment Pe
8) History of cerebrovascular accident (
ischemic attack (TIA), in the last 6 mon
9) Presence of any sign (clinical or ima
rapidly progressing (ie, not expected to
participation) brain disorder or brain tum
10) Presence of unstable arteriovenous
or other benign tumors. Stable lesions
acceptable;
11) History of porphyria;
12) Presence of clinically significant fin
examination, vital signs, electrocardiog
assessments, including, but not limited
insufficiency;
13) History of alcohol or drug abuse wit
screening visit as defined by DSM IV T
14) Participant who is known to be non
regime of anti-epileptic drugs;
15) Participant is a male or female of ch
refuses to use an acceptable form of co
or
16) Female participant who is pregnant
intends to become pregnant during the
surgically sterilized or have been post m
years are not considered to be of child
purposes of this study, acceptable form
double barrier methods (e.g. use of con
intrauterine device, and abstinence with
should participant become sexually act
17) Participant has taken part in any tri
device or product within the 2 months p

Random Sequence
Concealment
Blinding/Masking Double Blind Double Dummy
The primary efficacy variable is the partial onset
seizure (Type I) frequency per week over the
Treatment Period, excluding up- and
down-titration periods

a)Seizure freedom rate, b) % reduction for partial
onset seizure (Type I) freq. /week from baseline
to Treatment Period c)Responder rate (partial
onset seizures (type I) over Treatment Period, d)
Categorized % reduction from baseline in
seizure frequency for partial onset seizures
(Type I) over Treatment Period. The categories
include: -25%, -25% - 25%, 25% - 50%, 50% -
75%, 75% - 100%, and 100%, e) Reduction of
seizure frequency (Type I) from baseline to
Treatment Period


Enrollment (India)
Enrollment (Global)
Trial Months=6
Days=0

Trial (Global)
Recruitment Status of Closed to Recruitment of Participants
Trial (India)
Publication Details
Brief Summary A phase III, international, double-blind, parallel-group, placebo-controlled
randomized study: evaluation of the efficacy and safety of phenobarbital a
adjunctive therapy in participants (17 to 70 years old) with partial onset
seizures. The primary objective of this study is to evaluate the efficacy of o
daily (OD) administration of 60 mg and 100 mg phenobarbital, in reducing
frequency in participants with partial onset seizures not fully controlled de
treatment with 1 to 3 concomitant anti-epileptic drugs (AEDs) or AEDs wi
Vagus Nerve Stimulator (VNS). The study participation is for 34 weeks an
includes 12 visits in 34 weeks. The participating countries are India, USA
Bulgaria. The study has started in USA & Bulgaria. In India, 175 subjects
be enrolled.
A phase III, international, double-blind, parallel-group, placebo-controlled
randomized study: evaluation of the efficacy and safety of phenobarbital a
adjunctive therapy in participants (17 to 70 years old) with partial onset
seizures. The primary objective of this study is to evaluate the efficacy of o
daily (OD) administration of 60 mg and 100 mg phenobarbital, in reducing
frequency in participants with partial onset seizures not fully controlled de
treatment with 1 to 3 concomitant anti-epileptic drugs (AEDs) or AEDs wi
Vagus Nerve Stimulator (VNS). The study participation is for 34 weeks an
includes 12 visits in 34 weeks. The participating countries are India, USA
Bulgaria. The study has started in USA & Bulgaria. In India, 175 subjects
be enrolled.

Type of Trial
Type of Study
Public Title of Study A clinical trial to study the effects of of levetiracetam as a first line monotherapy in patients
years) with partial seizures with or without secondary generalization
Scientific Title of An open, multicentric non-comparative study to evaluate, the efficacy and safety of levetir
Study a first line monotherapy in patients(>16years of age) with partial seizures with or without s
generalization

LEV-PHL/09/08

Investigator or overall Name Dr.Debashish Chowdhury
Trial Coordinator
Designation
Affiliation
Address Professor of Neurology G.B.Pant Hosp
New Delhi
DELHI
110002
India
Phone 09811458071
Fax
Email debashishchowdhury@hotmail.com

Person (Scientific Name Dr.Manoj Naik
Query)
Designation
Affiliation Chief Manager
Address Abbott Healthcare Pvt Ltd D-Mart Build
Road, Mulund (W)
Mumbai
MAHARASHTRA
400080
India
Phone 022-39536910
Fax 022-39536666
Email manoj.naik@piramal.com

Person (Public Query) Name Manoj.M.Prabhu
Designation
Affiliation
Address Abbott Healthcare Pvt Ltd D-Mart Build
Road, Mulund (W)
Mumbai
MAHARASHTRA
400080
India
Phone 022-39536910
Fax 022-39536666
Email manoj.prabhu@piramal.com

Material Support > Abbott Healthcare Private Limited D-Mart Building Goregaon Mulund Link Road Mulund
Mumbai-400080

Primary Sponsor D
Name Abbott Healthcare Pvt Ltd
Address
Type of Sponsor

Sponsor Nil

Recruitment India
Investigator
Dr.Venkateswarlu Andhra Medical College
Dr.Debashish G.B.Pant Hospital

Chowdhury

Committee
Committee
Committee

Problems Studied

Comparator Agent Intervention Levetiracetam 500mg
Comparator Agent Nil

Age From
Age To
Gender
Details 1.Patients of either sex with established
with or without secondary generalizatio
3.Newly diagnosed or treatment na&ium
4.Willing to give informed consent (for a
5.Women willing to use adequate contr

Details 1.Patients with seizures other than part
secondary generalization. 2.Patients w
disease. 3.Patients with history of pre e
4.Patients with hepatic or renal impairm
obstructive respiratory disease 6.Patien
disorder which needs treatment. 7.Patie
porphyria 8.Patients currently on other
oral anticoagulants 10.Patients receivin
receiving griseofulvin 12.Women who a
during the study period

Random Sequence
Method of Case Record Numbers
Concealment
a.Six months seizure freedom b.Twelve months
seizure freedom

a.Seizure free interval b.Safety c.Retention rate


No Date Specified
Enrollment (India)
Enrollment (Global)
Trial Months=0
Days=0

Trial (Global)
Trial (India)
Publication Details
Brief Summary An open, multicentric non-comparative study to evaluate, the efficacy and safety of levetir
a first line monotherapy in patients(>16years of age) with partial seizures with or without s
generalization. The study will be conducted at 2 centres in India only.60 patients satisfying
Inclusion / Exclusion criteria will be enrolled in the trial and will be allocated treatment with
Levetericitam with dose titration as per investigators discretion and seizures for period of o
We will be assessing the no. of patients with seizure freedom at end of one year treatmen

Type of Study Surgical/Anesthesia
Study Design Randomized, Parallel Group Trial
Public Title of Study Trial to compare two standard methods of surgical removal of bladder tumours namely mo
and bipolar cautery
Scientific Title of Monopolar versus Bipolar Resection of Bladder Tumours. A randomized control trial.
Study
NIL

Investigator or overall Name Nitin Sudhakar Kekre
Trial Coordinator
Designation Professor and Head
Affiliation Department of Urology
Address Department of Urology, Christian Medic
Vellore
TAMIL NADU
632004
India
Phone 0416-2282111
Fax
Email uro2@cmcvellore.ac.in

Person (Scientific Name Vivek Venkatramani
Query)
Designation Senior Registrar
Vellore
TAMIL NADU
632004
India
Phone 0-7639831979
Fax
Email docvivek@gmail.com

Person (Public Query) Name Vivek Venkatramani
Designation Senior Registrar
Vellore
TAMIL NADU
632004
India
Phone 0-7639831979
Fax
Email docvivek@gmail.com

Material Support > Nil
Name Department of Urology
Address Christian Medical College, Vellore
Type of Sponsor Research institution and hospital

Sponsor NIL
Recruitment India
Investigator
DrVivek Venkatramani Department of Urology

Committee
Institutional Review Approved
Board, Christian
Medical College,
Vellore

Type Name
Comparator Agent Intervention Bipolar trans-urethral resection
of bladder tumour
Comparator Agent Monopolar trans-urethral
resection of bladder tumour

Gender Both
Details - All bladder tumours udergoing TURT<
anesthesia

Details - Patients unfit for surgery
- Routine second TURT at 6 weeks for

Random Sequence
Method of Sequentially numbered, sealed, opaque envelopes
Concealment
Blinding/Masking Participant Blinded
Safety and efficacy of Bipolar TURT will be
assessed by:
- Completeness of resection
- Obturator jerks and bladder perforation

- Average Blood loss
- TURT syndrome
- Quality of pathological specimen

- Resection time
- Cost-effectiveness
- Urethral strictures

Phase of Trial N/A

Enrollment (India)
Enrollment (Global)
No Date Specified

Trial Months=6
Days=0

Trial (Global)
Recruitment Status of Not Yet Recruiting
Trial (India)
Publication Details N/A
Brief Summary This study aims to ascertain the safety and efficacy of bipolar/ saline TURT and compare
present standard of care i.e. monopolar TURT.
Monopolar cautery is the current standard of resection for bladder tumours. It involves use
current with the active electrode in the cutting loop and the return electrode on the patient
a theoretical risk of increased current dissipation and collateral damage. Bipolar cautery c
both electrodes into the cutting loop thereby minimising the collateral damage.
Bipolar cautery is an established alternative for the performance of TURP however its exa
resection of bladder tumours is yet to be defined. It is presumed to be significantly safer th
monopolar TURT as it allows the use of a physiological solution i.e. Normal Saline, and ha
incidence of obturator jerk. The only randomized trial that exists on this subject has shown
better tolerated than monopolar TURT with equal efficacy.
Newly diagnosed patients of bladder cancer will be randomly allocated to either group for
of their tumour. Outcomes that will be measured include:
- Completeness of resection: Assessed by presence of muscle in the specimen and residu
gross tumour after surgery.
- Obturator jerk incidence during each procedure and rates of bladder perforation will be
compared.
- Average blood loss between the 2 procedures is to be compared by measuring pre-op a
post-op Hemoglobin values, duration of hematuria, quantity of saline required for irrigation
transfusion rates.
- Risk of TURT syndrome will be assessed by measuring pre-procedure and post-procedu
Sodium values.
- Specimen quality will be assessed by the examining pathologist by documenting the deg
PDF of Trial
CTRI Website
of cautery artifact in the specimen.
The differences between the 2 groups will be subjected to statistical analysis to determine their
significance.

Type of Study Drug
Public Title of Study To study how efficacious and safe Bicalutamide is in prostate cancer patients
Scientific Title of A Phase IV, Single Arm, Multi-Centric, Non-Comparative, Study to Evaluate Efficacy, Safe
Study Tolerability Of Bicalutamide In Advanced and/or Metastatic Prostate Cancer
CP/18/10

Investigator or overall Name Dr Sadashiv Bhole
Trial Coordinator
Designation Urologist
Affiliation Urologist
Address Ketaki Nursing Home and Urology Cen
Dhantoli,Nagpur NIL
Nagpur
MAHARASHTRA
440012
India
Phone 9822041307
Fax
Email sadashivbhole@gmail.com

Person (Scientific Name Dr Nitin Joshi
Query)
Designation Associate Director Medical Affairs & Sa
Affiliation Associate Director Medical Affairs & Sa
Address Karmic Lifesciences, 802, Building No.
Plot No. 3, TTC Industrial Area, Airoli, N
Thane
MAHARASHTRA
400708
India
Phone 02261170410
Fax 02261170499
Email nitin.joshi@karmiclifesciences.com

Person (Public Query) Name Dr Sadashiv Bhole
Name Dr Sadashiv Bhole
Designation Urologist
Affiliation Urologist
Address Ketaki Nursing Home and Urology Cen
Dhantoli,Nagpur NIL
Nagpur
MAHARASHTRA
440012
India
Phone 9822041307
Fax
Email sadashivbhole@gmail.com

Material Support > Cipla Ltd, Bellasis Road, Mumbai Central, Mumbai, Phone 02223082891 Fax 02225787
Name Cipla Ltd
Address Bellasis Road, Mumbai Central, Mumba
Fax: (022)25787855.

Sponsor NIL
Recruitment India
Investigator
Dr Dillip Kumar Acharya Harihar
Aggarwalla Regional Cancer
Centre
Dr Tanveer Maksud Bharat Cancer Hospital
and Research Institute
Dr G N Patel Jeevandip Hospital
Dr Sadashiv Bhole Ketaki Nursing Home

and Urology Center
Dr Ghanashyam Sparsh Hospitals and

Biswas Critical Care

Committee
ETHIC (Ethical Trial Of Approved
Health In Community)
Committee for Acharya
Harihar Regional
Cancer Centre
Committee for Bharat
Cancer Hospital and
Research Institute

Committee for
Jeevandip Hospital

Committee for Sparsh
Hospitals and Critical
Care
Global Health Concern Approved

Ethics Committee for
Ketaki Nursing Home
and Urology Center

Comparator Agent Intervention Bicalutamide Tablet

Gender Male
Details 1.A potential subject willing to give writt
own or LAR/Impartial witness in case o
2.Subjects entering the study should be
Years and less than 80 Years of age.<b
study should be clinically and histopath
diagnosed with advanced / metastatic p
4.Subjects participating in the study sho
contraception, in order to avoid female
5.Subjects participating in the study sho
PSA titre of greater than or equal to 10
have undergone prior radiotherapy and
the study provided, the radiotherapy an
least 4 weeks prior to the initiation of tre
drug. 7.Subjects participating in th
adequately controlled diabetes or cardi
from any. 8.Subjects entering the
Hematology Profile specifications as fo
greater than 9.0 gm / dl, Platelete great
cumm. 9.Subjects entering the st
chemistry specifications as follows: Hep
Bilirubin less than or equal to 1.5 (times
Transaminase (ALT) less than or equal
Transaminase (AST) less than or equa
Functions (Serum Creatinine less than
(ULN). 10.ECOG Performance St
2. 11.Subjects participating in the
expectancy of at least 6 months as per
 12.Subjects who are surgically ca
study. 13.Potential subjects shou
the study procedures. 

Details 1.Subjects with any clinically significant
including any concurrent disease that c
safety, as per the Investigators discretio
2.Subjects with known Central Nervous
having a clinically stable disease of at l
administration of the study drug (A pati
metastasis and having a clinically stabl
can be included in the study.)
3.Subjects under concurrent therapy w
anti-cancer therapy, including hormona
systemic anti-cancer therapy.
4.Subjects under treatment for ANY Ac
(UTI) or any other active clinically signi
5.Subjects who are known to be hypers
to any of the excipients.
6.Subjects who have been on the inves
prior to screening.

Random Sequence
Concealment
Percentage reduction in circulating PSA levels
as compared to baseline in patients of Prostate
Cancer undergoing treatment with Bicalutamide.

1.Percentage of subjects, who achieve complete
or partial response as compared to baseline,
assessed for overall response as per RECIST
Version 1.1 using imaging studies (CT/MRI) at
Visit 4(Day90) and Visit 7 (Day180).
2.Percentage of subjects who achieve Time to
progression (TTP) defined as the time from the
start of treatment to the date of documented
progression, assessed for overall response as
per RECIST Version 1.1 using imaging studies
(CT/MRI) at Visit 4(Day90) and Visit 7 (Day180).
3. To evaluate Progression Free Survival (PFS)

defined as; the time from the start of treatment to
the end of the treatment with no worsening of the

disease condition.
4.Percentage reduction in Bone Marker Levels
(Bone Fraction Serum Alkaline Phosphatase and
Serum Calcium) at visit 4(day 90) and Visit 7(day
180) compared to baseline values
1.Quality of Life using VAS for Pain.
1.Safety of the study drug will be estimated from

type, number, frequency and percentage of
subjects with AE(s)
7.Treatment Emergent Adverse Events (TEAE
defined as an AE which is definitely or probably
related to study medication) as per Common
Terminology Criteria for Adverse Events
(CTCAE), Version 4.02.


Enrollment (India)
Enrollment (Global)
Trial Months=3
Days=0

Trial (Global)
Trial (India)
Publication Details Not published in any journal.
This study is a Phase IV, Single Arm, Multi-Centric, Non-Comparative, Study to E
Efficacy, Safety And Tolerability Of Bicalutamide In Advanced and/or Metastatic
Cancer. The primary objective of the trial is to assess the reduction in circulating
Specific Antigen (PSA) levels in patients of Prostate Cancer undergoing treatmen
Bicalutamide. The duration of study is 42 weeks including 16 weeks of enrolmen
24 weeks treatment period and 2 weeks of post treatment follow-up. Total 36 pat
across 5 participating centers in India will complete the study. The study will be c
Brief Summary This study is a Phase IV, Single Arm, Multi-Centric, Non-Comparative, Study to E
Efficacy, Safety And Tolerability Of Bicalutamide In Advanced and/or Metastatic
Cancer. The primary objective of the trial is to assess the reduction in circulating
Specific Antigen (PSA) levels in patients of Prostate Cancer undergoing treatmen
Bicalutamide. The duration of study is 42 weeks including 16 weeks of enrolmen
24 weeks treatment period and 2 weeks of post treatment follow-up. Total 36 pat
across 5 participating centers in India will complete the study. The study will be c
in 3 phases: Screening Phase (Screening Visit), Enrollment Phase and Treatmen
(Visit 1-Visit 7) and Follow-up Phase (Visit 8).
PDF of Trial
04:50:22 GMT)
Pain
Parallel-Group, Multicenter Clinical
ain
Identifier
Protocol Number
ClinicalTrials.gov
Details of Principal Investigator
Details Contact Person (Scientific Query)

driyal
Director Clinical Management
maceutical Development (I) Pvt.Ltd
maceutical Development India Pvt Ltd., Vatika Business
rst India Place, 2nd floor, Block B, Sushant Lok Phase – 1
Gurgaon Road Gurgaon
8861
8874
driyal@ppdi.com
Details Contact Person (Public Query)
driyal
Director Clinical Management
maceutical Development India Pvt Ltd., Vatika Business

rst India Place, 2nd floor, Block B, Sushant Lok Phase – 1
Gurgaon Road Gurgaon
page 1 / 6
PDF of Trial
8861
8874
driyal@ppdi.com
Source of Monetary or Material Support
artado 19, 4745-457 S. Mamede do
Primary Sponsor Details

la C SA
ela C S.A. À Avenida da Siderurgia Nacional, Apartado 19,
S. Mamede do Coronado, Portugal
eutical industry-Global
Address
01-Dynasty B-Wing (Kanakia Spaces)
Andheri-Kurla Road, Andheri East,
Mumbai-400059, India
Site Address Phone/Fax/Email

VF 765, ABC +91-9936507362

Complex,Kanpur Road, +9152-246-5223
Alambagh-226005 drdeepakdewan@rediff
Lucknow mail.com
UTTAR PRADESH
rch No. 416, 4th Cross, +91 8025421333

,2nd Block, Kalyan +91 8025902546
Nagar-560043 dr_paramesh@hotmail.
Bangalore com
KARNATAKA
,# Jawaharlal Nehru +91 11 23234350

ck, Marg,-110002 +91 1123234350
New Delhi mmehndi@hotmail.com
DELHI
er P. B. No. 3209, +91 4224323202

,Avanashi +91 4222627782
Road-641014 kalyani_vijayan@rediff
Coimbatore mail.com
TAMIL NADU
314/30, Mirza Mandi +91-93 3607 7839

,Chowk-226003 +93 0522 4079157
Lucknow sandeepkumar.gupta@
UTTAR PRADESH rediffmail.com
page 2 / 6
PDF of Trial
Department of +91 1414075120

Neurology,,Jawahrlal +91 1415101185
Nehru Marg-302004 sharmadrbhawna@gma
Jaipur il.com
RAJASTHAN
e Room No. 1 & 2, OPD +91 1123232400

Block, 175, ,NSK Salaj +91 1123230132
Vadapalani-600026 doc_suresh@yahoo.co
Chennai m
TAMIL NADU
Date of Approval Is Independent Ethics

Committee?
10/08/2010 Yes
01/09/2010 Yes
14/12/2010 No
15/09/2010 No
20/08/2010 No
29/10/2010 No
13/08/2010 No
Date
11/10/2010
Condition
Diabetic Neuropathic Pain
ame Details
slicarbazepine acetate (BIA Eslicarbazepine acetate 800 mg
093) once daily (QD): Experimental
slicarbazepine acetate (BIA Eslicarbazepine acetate 1200
093) mg QD: Experimental
slicarbazepine acetate (BIA Eslicarbazepine acetate 1600
093) mg QD: Experimental
acebo Placebo Comparator
Inclusion Criteria
ar(s)
ar(s)
nd female outpatients aged 18 years or older. Female

are of nonchildbearing potential, defined as surgical
n (hysterectomy or bilateral oophorectomy or tubal ligation)
2 years postmenopausal (spontaneous amenorrhea for at
months before Visit 1), or if of childbearing potential,
agree to use a medically acceptable nonhormonal method
page 3 / 6
PDF of Trial
eption. 2. Diagnosis of Type 1 or Type 2
mellitus. 3. Pain due to bilateral peripheral
pathy caused by Type 1 or Type 2 diabetes mellitus. 
ave stable glycemic control, as assessed by the
or, and have glycosylated hemoglobin proportion of less or
n 11 percent before randomization. 5. A mean
ween 4.0 and 9.0, inclusive, on the 24 hour average pain
assessment and Visit 3 (ie, 5 of 7 days, 6 of 8 days, 7 of 9
of 10 days). 6. Compliance with patient diary
n. 7. If not used to treat DNP, subjects are
to take nonsteroidal anti inflammatory drugs and selective
reuptake inhibitors if they were kept on a stable dose for 1
or to Screening and are foreseen to remain stable
ut the study. 8. Competent and able to freely
nformed consent. 9. Female subjects of
ng potential, who are not currently breastfeeding, must
gative serum pregnancy test at Visit 1. 
Exclusion Criteria
al exposure to drugs known to cause neuropathy. 2.
t skin lesions (active infection, ulcer, etc). 3. Peripheral
disease with a history of amputation, except amputation of
nown intolerance to ESL or to other carboxamide
s (eg, carbamazepine or oxcarbazepine) or frequent or
ergic reactions with multiple medications. 5. Subjects who
y participated in a clinical study with ESL. 6. Major
c disorders. 7. Serious or unstable disease that could
se participation cause hospitalization during the study. 8.
r third degree atrioventricular blockade not corrected with a
er or any clinically significant abnormality in the 12 lead
diogram as determined by the investigator. 9. Subjects
following drug classes and individual drugs are excluded:
zepines (except short half life sleep agents), skeletal
laxants, orally administered steroids, capsaicin, mexiletine,
acting analgesics (dextromethorphan, tramadol), opiates,
ocaine, anticonvulsants, tricyclic antidepressants, and
norepinephrine reuptake inhibitors. These drugs require a
washout period of at least 5 times the half life and should
d appropriately using product label instructions as a guide.
ant clinical laboratory abnormality that, in the investigator's
an compromise the subject's safety. 11.History of drug
dependence (drug categories defined by DSM IV) within
ear, excluding nicotine and caffeine. 12.Subjects who, in
us 30 days, received treatment with a drug that had not
egulatory approval for any indication at the time of study
History of recurrent epileptic seizures except febrile
14.History of severe gastroparesis or gastric bypass
5.Neurolytic treatment for DNP. 16. Injected anesthetics or
e within 30 days of Visit 1. 17. Malignancy within past 2
History of chronic hepatitis B or C within the past 3 months
immunodeficiency virus infection. Note: Currently subjects
age of 65 years are not being enrolled in the study from
per Regulatory approval granted by Drugs Controller
f India (DCGI).
Timepoints
page 4 / 6
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Time Frame: 12 weeks
Timepoints

nly for Completed/Terminated trials

ly for Completed/Terminated trials
page 5 / 6
PDF of Trial
800, 1200, or 1600 mg OD) in subjects

ouble-blind study phase comprising a
ntenance phase, and a 4-week
tion phase is included as this is
maintenance phase. After the 19-week
ubsequent 36-week OL phase of ESL
een 800 mg and 1600 mg ESL OD,
r country participating in the study are
sia, South Africa, and Spain. The
and first subject enrollment is projected
dia. The study was prematurely
page 6 / 6
PDF of Trial
04:50:32 GMT)
mide an antiepileptic drug in treatment

further confirm the safety and efficacy
s.
ents with Partial, Generalized and
bservational Study Acronym: PMS
Identifier
Protocol Number
rinivasan
ute Care Hospital Mylapore
ADU
066963
1950@gmail.com
h Dash
Medical Advisor
Medical Advisor
rmaceuticals India Private Limited, 1st Floor, B-Wing,
Centre, Krishanlal Marwah Marg, Andheri east Eisai
euticals India Private Limited, 1st Floor, B-Wing, Marwah
rishanlal Marwah Marg, Andheri East
SHTRA
311
720
eisai.co.in
h Dash
h Dash
Medical Advisor
Medical Advisor
rmaceuticals India Private Limited, 1st Floor, B-Wing,
Centre, Krishanlal Marwah Marg, andheri east Eisai
euticals India Private Limited, 1st Floor, B-Wing, Marwah
rishanlal Marwah Marg, Andheri east
page 1 / 8
PDF of Trial
SHTRA
311
720
eisai.co.in
ivate Limited with registered office at
Andheri East, Mumbai - 400072

rmaceuticals India Private Limited. 1st Floor, B-Wing,
Centre, Krishanlal Marwah Marg, Andheri East, Mumbai -
Address
ced Neurology & Malviyanagar,-302017 +919529459370

peciality Hospital Jaipur sunitanu@yahoo.com
RAJASTHAN
Greams Road,-600006 +919047667154
Chennai aherfchennai@gmail.co
TAMIL NADU m
,-500015 +919848036486
Not Applicable doctoradabal@gmail.co
N/A m
e Govind Marg,-302004 +919828711808

Jaipur drneerajbhutani@rediff
RAJASTHAN mail.com
Opposite Sichi Sagar +919980958080

Hotel,RT Nagar-560010 ncmanju@yahoo.com
Bangalore
KARNATAKA
Rajarathinam +919840017893
h Street,Kilpauk-600010 mgrmrs@gmail.com
Chennai
TAMIL NADU
ality ,-400049 +919833210820

arch Mumbai shettyashutosh@rediff
MAHARASHTRA mail.com
pital Malviya Nagar,-302017 +919829063895

Jaipur drrajaram195@rediffma
RAJASTHAN il.com
page 2 / 8
PDF of Trial
0100 +919840642724
drdineshnayak@gmail.c
om
Niv +919446541379
2301 mkmenon66@gmail.co
m
+919947239459
vidyamadhavana@yah
oo.co.in
+919745609111
bobvarkey@gmail.com
+919446541379
hellomahesh@hotmail.c
om
+919810009316
renua57@hotmail.com
+919849049047
reachkavyasruthi@gma
il.com
H
1301 +919811933661
vivekrooma@yahoo.co.i
n
+919415487294
asadabbas_ncc@rediff
mail.com
7 +919848054189
drdshreedhar@yahoo.c
H o.in
+919415487294
veeresh_bajpai@rediff
mail.com
+919924038382
0015 myjitender1975@gmail.
com
+919829053525
drguptasuresh@gmail.c
om
+919820310850
ravatsh@yahoo.com
+919848194728
randhi2000@yahoo.co
m
H
page 3 / 8
PDF of Trial
Navrangpura,-380009 +919824635078
Ahmadabad ruchirdivatia@gmail.co
GUJARAT m
Navrangpura,-380009 +919824635078
Ahmadabad ruchirdivatia@gmail.co
GUJARAT m
Porur,-600116 +919444064641
Chennai drcuv@rediffmail.com
TAMIL NADU
Narayanguda,X +919848782945
Road-500029 gopalchevuru@yahoo.c
Hyderabad o.in
ANDHRA PRADESH
Mylapore,-600004 +919841219579
Chennai avsekhar1950@gmail.c
TAMIL NADU om
,-530002 +919848194728
Visakhapatnam nprneuro@gmail.com
ANDHRA PRADESH
Kummar guda,Near +919848036486
passport Office-500003 satyangali@gmail.com
Not Applicable
N/A
tal Begumpet,-500016 +919849025864

Hyderabad vnmathur2@rediffmail.c
ANDHRA PRADESH om

Committee?
No Date Specified Not Available

page 4 / 8
PDF of Trial
Not Available
Not Available
Not Available
Not Available
Not Available
Not Available
Not Available
Not Available
Not Available
Not Available
Not Available
Not Available
Not Available
Not Available
page 5 / 8
PDF of Trial

Date
No Date Specified
Condition
Epilepsy
ame Details
nisamide 100mg tablets 100 to 600mg daily in 1 to 3
divided doses for 24 weeks
ot applicable Not applicable
page 6 / 8
PDF of Trial
Inclusion Criteria
female subjects, 18 to 75 years of age inclusive 2.Treated
ed subjects suffering from any of the following types of
a.Partial Seizures: Simple Partial Seizures, Complex
izures & Secondarily generalized tonic clonic seizures
ized Seizures: Tonic-clonic seizures, tonic seizures &
bsence seizures c.Combined seizures (mixed) 3.Subjects
d a computed tomography (CT) or magnetic resonance
MRI) done within the last upto 10 years that ruled a
ve cause of epilepsy. 4.Female subjects without child
otential (2 years postmenopausal, bilateral oophorectomy
gation, complete hysterectomy) are eligible. 5.Female
with childbearing potential must not be pregnant as
by a negative pregnancy test at screening and enrollment
be lactating and must be using a medically acceptable form
eption, for the duration of the study and for one month
discontinuation of the study drug. 6.Patients willing to take
ations as directed, maintain a seizure dairy, report adverse
d willing to come for the follow-ups as per schedule.
o comply with the protocol requirements. 8.Able and willing
e written informed consent.
Exclusion Criteria
s with history of non-epileptic seizures (e.g. metabolic,
eizures). 2.Subjects who have experienced seizures
drugs, alcohol, acute medical illness, mental retardation,
s with situation related seizures. 3.Subjects with
ve encephalopathy or findings consistent with progressive
ase or lesion (e.g. infection, demyelination or tumour).
s with a history of any significant or currently uncontrolled
hich in the opinion of the investigator will interfere with the
f this study or the assessment of safety & efficacy of the
g. 5.Subjects already receiving zonisamide therapy.
s who have received an investigational new drug or device
t three months before screening and enrollment. 7.Subjects
n hypersensitivity to zonisamide or sulphonamides.
s with known abnormal renal function (serum creatinine
dL) or abnormal hepatic function (Aspartate
sferase [AST] and alanine aminotransferase [ALT] >2
upper normal limit). 9.Subjects with a history of psychiatric
mood disorder requiring electro-convulsive or drug therapy
vious 6 months which is considered uncontrolled; a history
attempt; alcohol or drug abuse. 10.Subjects currently
bonic anhydrase inhibitors (acetazolamide). 11.Subjects
aking Mono-Amine Oxidase Inhibitor?s (MAO-I?s).
ts having a history of pancreatitis, nephrolithiasis or
iuria, clinically significant laboratory abnormalities
e of metabolic imbalance.
Timepoints
Total 7 visits from baseline - at 4 weekly intervals
page 7 / 8
PDF of Trial
- Over 24 weeks Study period
Timepoints
Total 7 visits from baseline - at 4 weekly intervals
- Over 24 weeks Study period
vational post marketing surveillance

adjunctive therapy or monotherapy in
nitiating dose of 100mg/day titrated to
and tolerability over a 24 weeks
ts with partial, generalized or combined
e enrolled based on the inclusion and
y at every 4 weekly interval for 24
be evaluated for clinically reportable
lerability to Therapy (PGATT) on a
eizure frequency as the primary
data will be evaluated to determine the
y from baseline) and seizure freedom
page 8 / 8
PDF of Trial
04:50:39 GMT)
pranolol in the Prophylaxis of Chronic
pranolol in the Prophylaxis of Chronic
Identifier
NIL
mas
student college of pharmaeutical sciences, Medical
Trivandrum
cable
486
s2287@gmail.com
as Iype
and Head of Department of Neurology Medical College,

m
cable
317
e@gmail.com
as Iype
and Head of Department of Neurology Medical College,

m
cable
page 1 / 3
PDF of Trial
317
e@gmail.com

Address
Professor and Head , 09446230317

department of beenaiype@gmail.com
neurology,Medical
College-695011
Not Applicable
N/A

Committee?
Date
No Date Specified
Condition
Chronic migraine
ame Details
mitriptyline 10 mg once daily
opranolol 40 mg once daily
Inclusion Criteria
iagnosed with chronic migraine according to IHS criteria

10 years
Exclusion Criteria
with asthma, depression, anxiety, hypotension and mental
n patients using anti convulsants, beta blockers, psychiatric
AO inhibitors
page 2 / 3
PDF of Trial
Timepoints
baseline data assessment and after 3 months
therapy
Timepoints
baseline data assessment and after 3 months
therapy

cacy of Amitriptyline and Propranolol in

res 45 patients. Primary outcome is
ore ) and score after 33 months
of headaches. The centre is the
India.The secondary outcomes include
ne associated symptoms before and
page 3 / 3
PDF of Trial
04:50:45 GMT)
Assay (IGRA)in diagnosis and prognosis
lood and CSF of Tuberculous
Identifier
NIL
Mukund Ramrao
eurology, CSMMU, chowk Dept of neurology, CSMMU,
RADESH
658
805
vidhate@yahoo.co.in
Mukund Ramrao
sident
RADESH
658
805
vidhate@yahoo.co.in
Mukund Ramrao
RADESH
page 1 / 3
PDF of Trial
658
805
vidhate@yahoo.co.in
Address
Dept of neurology, 02532531658

CSMMU, 05222258805
chowk,-226003 drmukundvidhate@yah
Lucknow oo.co.in
UTTAR PRADESH

Committee?
Date
No Date Specified
Condition
Tuberculous meningitis
ame Details
L NIL
L NIL
Inclusion Criteria
headache, meningismus, other signs and clinical

ons of meningitis of more than 2 weeks duration. 2. Typical
inal fluid (CSF) features including pleocytosis with more
ells, lymphocytes greater than 60%, protein greater than
and glucose level less than 60% of the corresponding
cose level. Presumptive diagnosis of TBM will be made
the clinical criteria with typical CSF features and at least
following supporting criteria: 1. Radiographic findings
chest X-ray that confirmed pulmonary TB (reticulonodular
upper lobes with or without cavitatory lesions), 2.
halous from brain computerized tomography (CT) scan, 3.
e to anti-tuberculous treatment after 4 weeks.
Exclusion Criteria
tients who already received more than 30 days of
page 2 / 3
PDF of Trial
ulous drugs and steroids. 2. The patient declined to give
Timepoints
Timepoints
NIL

e newer diagnostic tool for rapid

is (TBM) is not well established. In the
IGRA in blood and CSF of TBM
pared IGRA results with the results of
ase chain reaction (PCR). Methods: In
N-TB Gold In-Tube test (QFT-G-IT) in
so, the blood and CSF interferon
BM cases. The diagnostic and
ixteen patients (44.4%) in TBM case
) tested positive by whole blood
ficant (p=0.64). The CSF QFT-G-IT
determinate due to poor mitogen
esponse and TST results (77.7%;
TBM group had positive CSF PCR for
ood interferon gamma levels and CSF
306 (95% CI: 0.228-0.384); p=0.037].
me at 6 months. The mean blood
.01 IU/mL at baseline to 3.18±4.25
hs were highly inconsistent.
4%) and specificity (62.5%) in
IGRA was not useful either in
e newer diagnostic tool for rapid
is (TBM) is not well established. In the
IGRA in blood and CSF of TBM
pared IGRA results with the results of
ase chain reaction (PCR). Methods: In
N-TB Gold In-Tube test (QFT-G-IT) in
so, the blood and CSF interferon
BM cases. The diagnostic and
ixteen patients (44.4%) in TBM case
) tested positive by whole blood
ficant (p=0.64). The CSF QFT-G-IT
determinate due to poor mitogen
esponse and TST results (77.7%;
TBM group had positive CSF PCR for
ood interferon gamma levels and CSF
306 (95% CI: 0.228-0.384); p=0.037].
me at 6 months. The mean blood
.01 IU/mL at baseline to 3.18±4.25
hs were highly inconsistent.
4%) and specificity (62.5%) in
IGRA was not useful either in
ness of blood IGRA response was
rom studies in large number of TBM
ies.
page 3 / 3
PDF of Trial
04:50:50 GMT)
egistered Retrospectively
Identifier
NIL
i Tripathi
professor
Neurology
5, 7th floor ,Dept. of Neurology,AIIMS-New Delhi
i
494
248
pathi@gmail.com
harma
search Fellow

i
494
248
11@gmail.com
harma
search Fellow

i
494
248
11@gmail.com
page 1 / 4
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nstitute of Medical Sciences-New Delhi
institution and hospital
Address
NIL
Room-705 ,7th floor 01126594494

Dept. of Neurology, 01126588248
C.N.Centre manjari.tripathi@gmail.
New Delhi com
DELHI

Committee?
11/11/2010 No
Date
No Date Specified
Condition
NON-EPILEPTIC SEIZURES(NES).
ame Details
unselling Counseling is a form of
psychotherapy in which a
Counselor tends to be
“non-directive”, i.e. not offering
advice or specific help in
overcoming symptoms, but
more supporting the client in
talking through their problems
and coming to their own
conclusions how best to deal
with them.
ognitive Behavior Therapy Cognitive behavioral therapy

(CBT) is a psycho therapeutic
approach that addresses
dysfunctional emotions,
maladaptive behaviors and
cognitive processes and
contents through a number of
goal-oriented, explicit
systematic procedures. CBT
helps individuals replace
"maladaptive… coping skills,
cognition, emotions and
behaviors with more adaptive
ones",by challenging an
page 2 / 4
PDF of Trial
individuals way of thinking and

the way that he/she reacts to
certain habits or behavior.
BT & Counselling This combination of intervention
will encompass principles and
techniques from both the
schools of psycho therapy, with
the purpose of enhancing the
eclectic recovery of the patient
Inclusion Criteria
ar(s)
ar(s)
-epileptic Patients. 2) Male /females and

bove 10 years. 
Exclusion Criteria
with Epilepsy
s with epilepsy with NES
s with any other disease
n below 10 years.
Operator Blinded
Timepoints
will prove 4 biweekly counselling sessions
peedy 4 biweekly CBT Session
arison to
isolation.
Timepoints
1st followup after 3 months
2nd followup after 6 months.

nown as non-epileptic attack
page 3 / 4
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page 4 / 4
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04:50:55 GMT)
s effect on the survival and recovery.
ve factors and its impact on the
Identifier
NIL
ut MD
urology C.S.M.M.U(chchatrapati shahu maharaj medical

, Lucknow
RADESH
149
r@gmail.com
ut MD

, Lucknow
RADESH
149
r@gmail.com
ut MD

, Lucknow
RADESH
149
page 1 / 3
PDF of Trial
r@gmail.com
y,lucknow..
Address
department of neurolog 05222258852

y,C.S.M.M.U,medical -
aded chowk-226003 garg50@yahoo.com
al Lucknow
UTTAR PRADESH

Committee?
Date
No Date Specified
Condition
made to study the incidence of hydrocephalus in
patients with TBM on admission using MR
imaging and its progression alongwith clinical
outcome.
ame Details
nil
nil
nil
nil
Inclusion Criteria
will be included in the study- Applying criteria given by

et al Fever , headache, signs of meningismus and other
esentations of meningitis lasted for more than 2 weeks.
erebrospinal fluid (CSF) features including pleocytosis with
n 20 cells, lymphocytes greater than 60%, protein greater
mg% and glucose level less than 60% of the corresponding
cose level. Sterile bacterial and fungal culture
page 2 / 3
PDF of Trial
Exclusion Criteria
s who have already taken ATT for more than 3 months. 2.
with cryptococcal meningitis 3. Any other cause for
s detected during the course of therapy. 4. If the consent is
ble or problematic follow up is anticipated.
Timepoints
0,1,3 AND 6 months
Timepoints
nil

U History and clinical examination CSF
n of hydrocephalus Patient assessment
ollment Follow up MRI and patient
page 3 / 3
PDF of Trial
04:50:59 GMT)
e cytokinines and metalloproteinases in

encephalitis.
Metalloproteinases in Patients with
Metalloproteinases in Patients with
Identifier
NIL
N KUMAR TIWARI
ident, departement of neurology,chatrapatisahuji maharaj

niversity LUCKNOW
RADESH
043
ri14@gmail.com
R K GARG
PARTEMENT OF NEUROLOGY Chatrapati sahuji maharaj

niversity,KGMC
RADESH
852
yahoo.com
R K GARG
PARTEMENT OF NEUROLOGY Chatrapati sahuji maharaj

niversity,KGMC
RADESH
page 1 / 3
PDF of Trial
852
yahoo.com
JI MAHARAJ MEDICAL

EMENT OF NEUROLOGY,CHATRAPATI SAHUJI
J MEDICAL UNIVERSITY, LUCKNOW UP
Address
FN LUCKNOW,LUCKNOW 05222258852
TRA -226003 garg50@yahoo.com
Lucknow
AL UTTAR PRADESH

Committee?
Date
No Date Specified
Condition
sub acute sclerosing panencephalitis
ame Details
mbar puncture to obtain csf 1 ml of csf
mple 1 ml. of patients of
bacute sclerosing
nencephalitis
f of control patients 1 ml 1 ml csf sample
atients who are undergoing
inal anesthesia
Inclusion Criteria
s of subacute sclerosing panencephalitis who fullfill the
iterion
Exclusion Criteria
page 2 / 3
PDF of Trial
f tubercular meningitis,AIDS,fungal meningitis, viral

s ,viral encephalitis and other infectious meningitis
Timepoints
CORELATION WILL BE MADE BETWEEN CSF
PROINFLAMMATORY MARKERS LEVEL AND
CLINICAL,STAGING,EEG AND
RADIOLOGICAL FEATURES
Timepoints
nil

sub acute sclerosing panencephalitis

page 3 / 3
PDF of Trial
04:51:05 GMT)
SAFETY OF IN-AQUL-002 TABLET

E TABLET AS ADJUNCTIVE
PARTIAL-ONSET SEIZURES
OSPECTIVE, MULTICENTRE
SAFETY OF IN-AQUL-002 IN
EASE AS ADJUNCTIVE
PARTIAL-ONSET SEIZURES
Identifier
DCGI
dra C Rane
resident
rma
rmaceuticals Ltd Chinubhai Center Ashram Road
ad GUJARAT 380009 India Intas Pharmaceuticals Ltd
i Center Ashram Road Ahmadabad GUJARAT 380009
ad
T
aspharma.com
Charan Sahoo
dviser
dvisor
ad
T
aran_sahoo@intaspharma.com
Shah
dviser
rma
page 1 / 6
PDF of Trial

ad
T
ad
T
hah@intaspharma.com

rmaceuticals Limited
ad GUJARAT 380009 India
eutical industry-Indian
Address
y 6 & 7, bassaye Nagar, 0240-2326530

,Opposite Yashoda majiddoc4@yahoo.com
Hospital, -
Aurangabad
BIHAR
117, Hindu Colony, ,5th 9820010974

Lane, Dadar (E), - sagaroak@hotmail.com
Mumbai
MAHARASHTRA
al Near L.I.G. Square 0731-4029343

Agra Bombay Road drabhaybhagwat@rediff
452008 mail.com
Indore
MADHYA PRADESH
s 22, Palm Spring 079-26407372

Complex, ,Near World mayank_doctorneuro@
Business House, Near yahoo.com
Parimal Garden,
Ellisebridge, -380006
Ahmadabad
GUJARAT
Matru Mandir Ground 9820804940
floor, ,Taedeo road, nitinsampat@hotmail.co
opposite Bhatia m
Hospital, Grant Road,
-400007
Mumbai
MAHARASHTRA
alin Shah?s clinic 401, Gala Business 079-26304422

Center-2, ,Near
page 2 / 6
PDF of Trial
Rajhans Society, drshalinshah@yahoo.c

Xavier's College Corner o.in
Road,-380006
Ahmadabad
GUJARAT
pital Fortis Escorts 9829063895
Hospital,JLN Marg,- drrajaram195@gmail.co
Not Applicable m
N/A
20/1, Khare marg, 0712-6610101

,Behind Vijayanand pkshembalkar@hotmail
society, Dhantoli, .com
-440012
Nagpur
MAHARASHTRA
Civil lines, 0724-2426162

,Akola-444001 mkanphade@yahoo.co
Akola m
MAHARASHTRA
pital Department of 9823099173

Neurology, ,Govt nathanielsase@hotmail.
Medical College, Miraj com
Wanless Hospital,
-416410
Not Applicable
N/A
Shreenath Apartments, 9821346472

,Opp. Sony Mony drmanojrajani2009@gm
Electronics, SV Road, ail.com
Borivali (W) -400091
Mumbai
MAHARASHTRA
e Lotus House, 33/A, 022-22001180
New Marine Lines, suryaneuro@hathway.c
,Next to Liberty om; nirmal_surya@yah
Cinema, -400020 oo.com
Mumbai
MAHARASHTRA

Committee?
27/10/2010 No
05/10/2009 No
08/10/2010 No
21/10/2010 Yes
21/10/2010 Yes
21/10/2010 Yes
page 3 / 6
PDF of Trial
21/10/2010 Yes
21/10/2010 Yes
21/10/2010 Yes
21/10/2010 Yes
21/10/2010 Yes
Date
16/12/2010
Condition
REFRACTORY PARTIAL-ONSET SEIZURES
ame Details
-AQUL-002 Start study medication as one
tablet once daily. At first
follow-up if medication is well
tolerated then escalate the dose
to two tablets once daily. In
case need for further titration,
dose can be increased to three
tablets once daily. From study
end visit 8, gradual tapering off
of study medication will be done
over a period up to two weeks
xcarbazepine 300 mg oral tablet Start study

stained-release medication as one tablet once
daily. At first follow-up if
medication is well tolerated then
escalate the dose to two tablets
once daily. In case need for
further titration, dose can be
increased to three tablets once
daily. From study end visit 8,
gradual tapering off of study
medication will be done over a
period up to two weeks
Inclusion Criteria
ar(s)
ar(s)
s of either sex, 18 to 65 years of age (both inclusive),

g treatment with one to three anti-epileptic drugs (AEDs)
or complex partial seizures with or without secondary
ation & having history of at least two partial-onset seizures
vious 4 weeks before screening 2. In case of females
bearing potential, non-pregnant, non-lactating, with
page 4 / 6
PDF of Trial
serum pregnancy test at screening and willing to use barrier
tive throughout the study treatment period 3. Patients
provide written informed consent 4. Patients willing to
th the study requirements such as regular recording of
ary and self administration of study medication throughout
treatment period
Exclusion Criteria
with 1. Only simple partial seizures without motor
s, 2. Primarily generalized epilepsy 3. Known rapid
ve neurological disorder, 4. Status epilepticus/cluster
within 3 months before screening 5. Seizures of
nic origin within the last two years 6. History of
enia or suicide attempts 7. An uncontrolled, relevant
isorder 8. Ongoing use of disallowed medications including
azepine, feblamate, diuretics (conventional diuretic doses),
ssin, 9. Cardiac arrhythmia including atrioventricular
10. Clinical laboratory abnormalities (SGPT/OT ≥
upper normal limit; or sodium < 130 mmol/L or total white
count < 3,000 cells/mm3; hematocrit < 35%; free T4 < 77
& T3 < 2.4 pg/ml; or serum creatinine ≥
0ml). 11. History of drug or alcohol abuse within the
2 years 12. Known hypersensitivity to carbamazepine or
epine formulations 13. Participation in other investigational
within 3 months preceding study entry 14. As deemed
ate for enrollment by investigating physician due to other
Timepoints
At the endpoint compared to baseline
Timepoints
At the endpoint compared to baseline

page 5 / 6
PDF of Trial
f IN-AQUL-002 with oxcarbazepine

with refractory partial onset seizures. It is
e in controlling seizure frequency and
ets as adjunctive treatment of Indian
e conducted in Indian patients only and
n the study is 27th December 2010.
page 6 / 6
PDF of Trial
04:51:10 GMT)
etalloproteinases in HIV seropositive
Identifier
NIL
Rai
D
ident
nt of Neurology Chhatrapati Shahuji Maharaj Medical
RADESH
707
j.rai@gmail.com
Garg DM
ology
of neurology, CSMMU
,
RADESH
707
yahoo.com
Garg DM
Garg DM

,
RADESH
707
page 1 / 3
PDF of Trial
yahoo.com
cable
L]
Address
Not Applicable
i Department of 0522-2733707
Neurology,Chhatrapati dr.dheeraj.rai@gmail.co
Shahuji Maharaj m
Medical
University,-226003
Lucknow
UTTAR PRADESH

Committee?
20/11/2010 Yes
Date
No Date Specified
No Date Specified
Condition
Tuberculous meningitis
ame Details
L Not Applicable
Inclusion Criteria
ar(s)
ar(s)
s fulfilling diagnostic criteria of tuberculous meningitis

Thwaites et al 17criteria 2. Patients with ELISA
or HIV 1 or 2 for HIV positive group 3. Age above 12
>
Exclusion Criteria
s not fulfilling above criteria 2. Patients with cryptococcal
s 3. Patients/ attendants refusing consent
Timepoints
page 2 / 3
PDF of Trial
1. one month
2. three month
3. six month
Timepoints
Not Applicable

F- IL-1, IL-2, IL-6, IFN- in
e well documented. The cytokine tumor
sis of M. tuberculosis. Although TNF-
nt of mycobacterial infections. Local
leads to altered blood-brain barrier
is 10,11 and has been implicated in
s evidence of significant blood-brain
sms are probably multifactorial,
ecently implicated. This thesis work is
nes (TNF- IL-1, IL-10 and IFN- and
nal fluid of patients with tuberculous
clinical correlation with disease severity
page 3 / 3
PDF of Trial
04:51:15 GMT)
n Behaviour
atal Behaviour
Identifier
NIL
Arya
atric Neurology, Dept of Pediatrics AIIMS, Ansari Nagar

i
rya4@gmail.com
ansoria
OD Pediatrics, NSCB Medical College, Jabalpur, MP

ediatrics NSCB Medical college
PRADESH
117
nsoria@yahoo.com
ansoria
ediatrics NSCB Medical college
PRADESH
117
nsoria@yahoo.com
page 1 / 3
PDF of Trial

r, MP
nt of Pediatrics, NSCB Medical College, Jabalpur, MP
Address
Department of 07612422117
Pediatrics, NSCB maya.chansoria@yaho
Medical College, o.com
Jabalpur, MP,-482003
Jabalpur
MADHYA PRADESH

Committee?
Date
No Date Specified
Condition
None (Normal healthy term newborns)
ame Details
usic 50 minutes/day
andard care Not applicable
Inclusion Criteria
vida mothers * 19 to 29 years of age * Singleton pregnancy
n 20 weeks of gestation
Exclusion Criteria
with significant co-existing medical diseases * Severe to
hearing loss
Timepoints
Day 3 of life
page 2 / 3
PDF of Trial
Timepoints
Not applicable

ound to influence foetal behaviour with

study evaluated the effect of ante-natal
aviour of their term appropriate-for-date
sessment Scale (BNBAS). Methods:
trial. Primigravida mothers aged 19-29
ss, with singleton pregnancy, with a
pre-recorded music cassette for
care (intervention arm) or standard care
eonatal behaviour were deemed as
clusters of BNBAS. Primary analysis
ound to influence foetal behaviour with
study evaluated the effect of ante-natal
aviour of their term appropriate-for-date
sessment Scale (BNBAS). Methods:
trial. Primigravida mothers aged 19-29
ss, with singleton pregnancy, with a
pre-recorded music cassette for
care (intervention arm) or standard care
eonatal behaviour were deemed as
clusters of BNBAS. Primary analysis
page 3 / 3
PDF of Trial
04:51:21 GMT)
n anti-epileptic drug, Brivaracetam in
e of epilepsy or fits (partial onset
er, Parallel Group Study To Evaluate

0 Years Old) With Partial Onset
Identifier
Protocol Number
ClinicalTrials.gov

a Parikh
Director & Country Consultant for India
eutical Research Associates India Pvt. Ltd
, A-602 & A-603, C.T.S.No.1498 A/2 M.V. Road, Marol,
East), Mumba1 Mumbai (Suburban) The Qube, A-602 &
T.S.No.1498 A/2 M.V. Road, Marol, Andheri (East),
Mumbai (Suburban)
Suburban)
SHTRA
34107
34198
arna@prahs.com
hani
eam Manager
national
, A-602 & A-603, C.T.S.No.1498 A/2 M.V. Road, Marol,
East), Mumba1 Mumbai (Suburban) The Qube, A-602 &
T.S.No.1498 A/2 M.V. Road, Marol, Andheri (East),
page 1 / 7
PDF of Trial
Mumbai (Suburban)
SHTRA
34129
34198
gar@prahs.com
many,
Z BIOSCIENCES INCA Member of the UCB Group of
es
bel-Stra 10, 40789 Monheim, Germany,
Address
The Qube, A-603, C.T.S.No.1498 A/2 M.V.
Road, Marol, Andheri (East), Mumbai-400059,
MAHARASHTRA India
Neurology Block,Lake 91-9842142999

View Area, K. K. 914522581157
Nagar,625020 drsundarsms@gmail.co
Madurai m
TAMIL NADU
Room no. 2101,P.D. 91-99821087597

Hinduja National 91-22-24440425
Hospital & Medical roop_gursahani@hotm
Research Centre,Veer ail.com
Savarkar Marg, Mahim
page 2 / 7
PDF of Trial
(W)-400016
Mumbai
MAHARASHTRA
Room No 223/224,2nd 91-9820310850
S Floor, Old 91-22-24164206
d Building-400012 ravatsh@yahoo.com
Mumbai
MAHARASHTRA
M S Ramaiah Medical 91 80 22183125

College and Hospitals 91 8040528402
,MSRIT Post,New Bel devaraju.gm@metropoli
Road,-560 054 sindia.com
Bangalore
KARNATAKA
1-8-31/1, Minister 919848019036

td, Road,,-500003, 914027818844
Secunderabad sita_js@gmail.com
Hyderabad
ANDHRA PRADESH
Neurocare, Gajanan 919820572480

Avenue, Near Old rbaviskar@gmal.com
Nasik Mu nicipal
Corporation, Old Pandit
Colony, Nasik
422002.
Nashik
MAHARASHTRA

Committee?
Committee?
28/05/2011 No
20/04/2011 No
20/05/2011 No
09/05/2011 No
11/04/2011 Yes
30/04/2011 No
Date
07/04/2011
Condition
"epilepsy; partial onset seizures"
ame Details
ivaracetam (BRV). 10mg, 25mg, 50 mg. Dose
duration of 16 weeks, rote of
administration-Oral
acebo 10mg, 25mg, 50 mg. Dose
duration of 16 weeks, route of
administration-oral.
page 3 / 7
PDF of Trial
Inclusion Criteria
ar(s)
ar(s)
ible to participate in this study, all of the following criteria
met: 1. An Institutional Review Board
ependent Ethics Committee (IEC) approved written
consent form is signed and dated by the subject or by the
or legal representative. The consent form or a specific
m, where required, will be signed and dated by
r/> 2. Subject/legal representative is considered reliable
ble of adhering to the protocol (eg, able to understand and
diaries), visit schedule, or medication intake according to
ent of the Investigator. 3. Subjects (male or female)
o 80 years, both inclusive. Subjects under 18 years may
cluded where legally permitted and ethically accepted. 
s with a body weight ≥40kg. 5. Female
without childbearing potential (premenarcheal,
pausal for at least 2 years, bilateral oophorectomy or tubal
omplete hysterectomy) are eligible. Female subjects with
ng potential are eligible if they use a medically accepted
tive method. Oral or depot contraceptive treatment with at
#956;g ethinylestradiol per intake [or 50μg
radiol per intake if associated with any strong enzyme
g carbamazepine, phenobarbital, primidone, phenytoin,
epine, St. John?s Wort, rifampicin)], monogamous
ip with vasectomized partner, or double-barrier
tion are acceptable methods. The subject must understand
quences and potential risks of inadequately protected
tivity, be educated about and understand the proper use of
tive methods, and undertake to inform the Investigator of
tial change in status.Abstinence will be considered as an
e method ofcontraception if the Investigator can document
ubject agrees to be compliant. 6. Well-characterized
epsy/epileptic syndrome according to the 1989 International
gainst Epilepsy (ILAE) classification. 7. Presence of
eading compatible with the clinical diagnosis of focal
within the last 5 years. 8. Presence of a brain
puted tomography (CT) scan performed within the last 2
/> 9. Subjects having at least 8 Type I seizures [POS; focal
according to the 1981 ILAE classification)] during the
aseline Period with at least 2 Type I seizures during
eek interval of the Baseline Period. 10. Subjects
least 2 partial onset seizures whether or not secondarily
ed per month during the 3 months preceding V1. 
cts being uncontrolled while treated by 1 or 2 permitted
ant AED(s). Vagal Nerve Stimulation (VNS) is allowed
e counted as a concomitant AED. 12. Permitted
ant AED(s) and VNS being stable and at optimal dosage for
subject from at least 1 month (3 months for phenobarbital,
, and primidone) before V1 and expected to be kept
ing the Baseline and Treatment Period. 
zepine taken more than once a week (for any indication)
nsidered as a concomitant AED. 
Exclusion Criteria
reviously randomized within this study or any other prior
BRV as a dosing arm.
pe IA (1981 ILAE classification) nonmotor as only seizure
page 4 / 7
c.in
PDF of Trial
nzymes are below 2 times the upper limit of the reference
as clinically significant deviations from reference range

laboratory parameters: creatinine clearance calculated
, platelets 100,000/?L, or neutrophil cells 1,800/?L.
as clinically significant ECG abnormalities according to the
or.
as history of suicide attempt prior to randomization.
as ongoing psychiatric disease other than mild controlled
as known allergic reaction or intolerance to pyrrolidine

s and/or investigational product excipients.
as known multiple drug allergies or severe drug allergy.
pregnant or lactating woman.
as known alcohol or drug addiction or abuse within the last
ors, co-Investigators, their spouses or children, or any

aborators. If the Investigator has any other doubts
g the eligibility, he/she should consult UCB Study
or representative for clarification.
Timepoints
12 weeks
Timepoints
12 weeks
page 6 / 7
PDF of Trial
provide additional data confirming the

and to support a marketing
am in the indication of adjunctive
izures whether or not secondarily
and 200mg/day. Consistent with the
N01358 will include an 8-week Baseline
cy variable of N01358 will be Partial
atment Period. In India, we are
page 7 / 7
PDF of Trial
04:51:29 GMT)
egistered Prospectively
anti-epileptic drug Brivaracetam when

epilepsy or fits (partial onset seizures)
ong term safety and efficacy of
16 years or older with Epilepsy
Identifier
Protocol Number
ClinicalTrials.gov

a Parikh
Director & Country Consultant for India
, A-603, C.T.S.No.1498 A/2 M.V. Road, Marol, Andheri
umbai Mumbai (Suburban) The Qube, A-603,
1498 A/2 M.V. Road, Marol, Andheri (East), Mumbai
Suburban)
SHTRA
34107
34198
arna@prahs.com
hani
eam Manager
, A-603, C.T.S.No.1498 A/2 M.V. Road, Marol, Andheri
umbai Mumbai (Suburban) The Qube,A-603,
1498 A/2 M.V. Road, Marol, Andheri (East), Mumbai
Suburban)
page 1 / 4
PDF of Trial
Suburban)
SHTRA
34129
34198
gar@prahs.com
uite 100 Raleigh, NC 27617 UNITED

Z BIOSCIENCES INC A Member of the UCB Group of
es
Corp.Drive, Suite 100,Raleigh, North Carolina 27617 USA,
Address
The Qube, A-603, C.T.S.No.1498 A/2 M.V.
Road, Marol, Andheri (East), Mumbai-400059,
MAHARASHTRA India
Lake View Road,K. K. 919842142999

Nagar,Madurai-625 020 drsundarsms@gmail.co
Madurai m
TAMIL NADU
1-8-31/1, Minister 919848019036

td, Road,500 003 914027818844
Hyderabad sita_js@gmail.com
ANDHRA PRADESH
orial Gokula Metropolis 91 80 22183125

Clinical Research 91 8040528402
Center,,MSRIT Post, drrsrinivasa@hotmail.c
New Bel Road-560 054 om
Bangalore
KARNATAKA
page 2 / 4
PDF of Trial
Gajanan Avenue, Near 91-9820572480

Old Nasik Mu nicipal 91-253-2232660
Corporation, Old Pandit rbaviskar@gmail.com
Colony, 422002, India.
Nashik
MAHARASHTRA
al Department of 91 22 24440425
al Neurology, Room no. 91-99821087597
2101,,Veer Savarkar roop_gursahani@hotm
Marg, Mahim ail.com
(W)-400016
Mumbai
MAHARASHTRA
Department of 91-9820310850
Neurology, ,Room No 91-22-24164206
223/224, 2nd Floor, Old ravatsh@yahoo.com
Building, Parel, -400012
Mumbai
MAHARASHTRA

Committee?
28/05/2011 No
15/07/2011 No
20/05/2011 No
23/08/2011 No
30/04/2011 No
11/04/2011 Yes
Date
06/04/2011
Condition
Focal Epilepsy
ame Details
ivaracetam 10mg, 25mg, 50 mg, 52 weeks,
route of administration-oral
Inclusion Criteria
ar(s)
ar(s)
ompleted the Treatment Period of N01358. Subject

the Investigator believes a reasonable benefit from the
administration of BRV may be expected. 
Exclusion Criteria
as developed hypersensitivity to any components of the
onal medicinal product (IMP) or comparative drugs as
his protocol during the course of the core study
edical, neurological, or psychiatric disorders, or laboratory
ich may have an impact on the safety of the subject
pliance with the visit schedule or medication intake in the
page 3 / 4
PDF of Trial
BRV study
cal condition which, in the Investigator?s opinion, warrants
Timepoints
This will be summarized by 3-month periods over
the Evaluation Period.
Timepoints
3 months
epileptic treatment in subjects 16 years

jects who have completed N01358 the
protocol. N01358 is an adequate and
e efficacy and safety of BRV
e than or equal to16 years) with
379 will explore the long-term safety
artial Onset Seizures) whether or not
aracetam) for subjects who may benefit
ed.
page 4 / 4
PDF of Trial
04:51:36 GMT)
n patients with hemorrhagic stroke

ral hemorrhage
Identifier
NIL
ta
sident, Dept of neurology King George Medical University
RADESH
747
2003@yahoo.co.in
ta
RADESH
747
2003@yahoo.co.in
ta
RADESH
747
2003@yahoo.co.in
page 1 / 3
PDF of Trial
Address

ji dept of 05222258852
neurology,medical -
chowk-226003 drrajeshverma32@yaho
Lucknow o.com
UTTAR PRADESH

Committee?
Date
No Date Specified
Condition
To study the role of perihematomal edema in
long term outcome following intracerebral
hematoma.
ame Details
nil
nil
Inclusion Criteria
1602; Patients with SICH presenting within 72 hours from

of the acute symptoms would be included 
18 years
Exclusion Criteria
tricular extension ? Infratentorial location ? h/o
lation ? bleeding disorders ? hemorrhage related to
al neoplasm ? presence of AV malformations ? Critically ill
ion ? Presence of end organ damage ( CCF, respiratory
d others)
Timepoints
page 2 / 3
PDF of Trial
At discharge and after 12 weeks

At discharge and after 12 weeks
Timepoints
nil

cit of vascular cause extending beyond

constitute 10-15% of all stroke, most of
CH are known for a very devastating
own that activation of multiple
e perihematomaledema. There is
which leads to blood brain barrier
l coagulation activation is underlined by
agulation activation ) in patients with
arly important in the first 24 hours. As
clot the ferric iron produces oxidative
ation has been suggested between
at day 3 or day 4 by Manu Mehdiratta et
o modify the perihematomaledema
e local cytokine activation, high
study is aimed at defining the role of
12 week outcome in SICH, and also to
d hemoglobin and serum ferritin level
page 3 / 3
PDF of Trial
04:51:42 GMT)
goserelin in men with prostate cancer

dy Assessing the Safety and Efficacy of
pot (Zoladex) in Men with Prostate
Identifier
ClinicalTrials.gov
Protocol Number
Rajadhyaksha
Pharma Pvt Ltd, 85 Mittal Chambers, Opp Inox Theater,
Point , Mumbai 400021
SHTRA
464
380
adhyaksha@oncorxindia.com
Rajadhyaksha
irector
SHTRA
464
380
Rajadhyaksha

SHTRA
page 1 / 6
PDF of Trial
464
380

PharmaceuticalsInc
nology Drive, Irvine CA 92618Phone:
6700Facsimile:(949)788-6700
Address
85,Mittals Chambers,Nariman Point, Mumbai
400021
nd G3,3/7,Sector II, 91-9999489486

Rajinder Nagar,-201005 91-120-4380255
Ghaziabad sanjayuro@gmail.com
UTTAR PRADESH
968, Senapati Bapat 91-9822054176

Road, Pune - 411053 91-20-25651602
Pune shivadeo@bapats.in
MAHARASHTRA
X-9, Sector 12, Noida 91-9810111946

-201 301, Uttar Pradesh 91-120-2547744
Ghaziabad ajitsaxena@hotmail.co
UTTAR PRADESH m
i Department of Urology, 91-9839181465

Lucknow - 226003 91-522-2256543
Lucknow goelapul1@rediffmail.c
UTTAR PRADESH om
& Manik Bagh Road, 91-9827033520

Indore- 452014 91-731-2470068
Indore csthatte@gmail.com
MADHYA PRADESH
Department of Urology, 91-9814034185

al Ludhiana,Punjab-141 91-161-5010909
008 kjmammen@gmail.com
Ludhiana
PUNJAB
8-15, 3rd Floor, Sheetal 91-9825276278

and Shopping Square,(Old 91-261-2234409
e LB Cinema), Ghod kapilthakkar@gmail.co
Dod-Bhatar Road m
Junction, Surat -
395001
Surat
GUJARAT
re Opp. Basant 91-9820303774
page 2 / 6
PDF of Trial
Road, 91-22-25208021
- bradooa@gmail.com
91-9314800333
ar, 91-141-2547002
drmmbansal@yahoo.co
.in
, P. 91-9731209671
91-80-40206059
drraghunathsk@yahoo.
com
91-9825050336
91-79-26402435
06 bakshihemang@yahoo.
co.in
ical 91-22-66573254
91-22-23520508
shadvani2000@yahoo.
62 com
91-268-2520323
001 91-268-2520248
mrdesai@mpuh.org
ty R 91-20-43285018
e-41 91-20-66285019
rajendrakshimpi@gmail
.com
91-9824086834
ul 91-79-27437070
ad, drshreniks@gmail.com
52
nt, 91-79-26431616
to 91-79-26420285
Six drjanak@samvedurolog
ra, y.com
09
91-9820364294
91-22-23002638
ing, hemanturologist@gmail
.com
91-9335242329
page 3 / 6
PDF of Trial
Nagar, Lucknow - 91-522-2768899

226022 drdalela@sify.com
Lucknow
UTTAR PRADESH
ir Department of Urology, 91-9818024013
d New Delhi - 110029 91-11-26190954
l New Delhi nayankm@yahoo.co.in
DELHI
Department of Urology, 91-9830037314

8/5, Alipore Road, 91-33-24567090
Kolkata - 700027 kksarkar@gmail.com
Kolkata
WEST BENGAL

Committee?
10/11/2010 Yes
23/05/2011 Yes
23/05/2011 Yes
10/11/2010 Yes
30/08/2011 Yes
18/10/2010 No
28/01/2011 No
09/10/2010 No
15/03/2011 No
15/10/2011 No
19/03/2011 Yes
18/03/2011 No
21/02/2011 No
10/06/2011 No
page 4 / 6
PDF of Trial
27/01/2011 No
28/06/2011 No
26/10/2010 No
16/02/2011 No
09/08/2011 No
13/04/2011 No
Date
27/12/2010
Condition
Malignant neoplasm of prostate
ame Details
arelix Two SC injections of ozarelix 65
mg in the abdomen on Day 1
(LLQ and RLQ), followed by a
SC injection of 65 mg of
Ozarelix (abdomen LLQ) on day
8 and will receive 2 additional
SC injections of Ozarelix on
days 28 and 56 (alternating
injection sites).
oserelin One 3.6 mg SC injection in the

abdomen (LLQ or RLQ),
followed by a 3.6 mg SC
injection on Days 28 and 56
(alternating injection sites).
Inclusion Criteria
ar(s)
ar(s)
aged 18 years or older, with histologically proven prostate

any stages, for whom endocrine treatment is indicated.
Exclusion Criteria
one therapy prior to study entrance
page 5 / 6
PDF of Trial
Timepoints
Day 28 through Day 84,
Timepoints
1) during the first two weeks of treatment
2) at Day 3
rmation will be provided to the
s to assess the safety and efficacy of a

lin depot administered SC in men with
mized, open label 84 days study. Men
proven prostate cancer of all stages, in
dy entry. Prospective study subjects
le patients will enter the study. Patients
s (Ozarelix or Goserelin). Eligible
C injections of ozarelix 65 mg in the
on of 65 mg of Ozarelix (abdomen LLQ)
lix on days 28 and 56 (alternating
receive one 3.6 mg SC injection in the
n Days 28 and 56 (alternating injection
f enrollment is 25 Jan 2011 (
s to assess the safety and efficacy of a
lin depot administered SC in men with
mized, open label 84 days study. Men
proven prostate cancer of all stages, in
dy entry. Prospective study subjects
le patients will enter the study. Patients
s (Ozarelix or Goserelin). Eligible
C injections of ozarelix 65 mg in the
on of 65 mg of Ozarelix (abdomen LLQ)
lix on days 28 and 56 (alternating
receive one 3.6 mg SC injection in the
n Days 28 and 56 (alternating injection
f enrollment is 25 Jan 2011 (
page 6 / 6
PDF of Trial
04:51:47 GMT)
come of acute noncompressive
ssive myelopathies.
Identifier
NIL
A NARAYAN PRAHARAJ
AR,SAHARA STATE,JANKIPURAM, SENIOR
T,DEPTT OF NEUROLOGY,CSMMU,LUCKNOW,U.P.
RADESH
821
raj@gmail.com
K.GARG
ROLOGY, H.O.D.,DEPTT OF NEUROLOGY,

APATI SAHUJI MAHARAJ MEDICAL UNIVERSITY
W
RADESH
852
yahoo.com
K.GARG
ROLOGY, H.O.D.,DEPTT OF NEUROLOGY,

LUCKNOW
RADESH
page 1 / 3
PDF of Trial
852
yahoo.com
TY,LUCKNOW,U.P.,INDIA
Address
W,U. DEPTT OF NEUROLO 05222258852

GY,CSMMU,-226003 garg50@yahoo.com
Lucknow
UTTAR PRADESH

Committee?
Date
No Date Specified
Condition
ACUTE NONCOMPRESSIVE MYELOPATHY
ame Details
L NIL
L NIL
Inclusion Criteria
ts developing acute onset motor and/or sensory and/or

c disturbance with/without a definite sensory level. (2)
cal deficit maximal within 72 hours of symptom onset and
ssion over 3 weeks. (3) Absence of mass lesion or
abnormality on MRI.
Exclusion Criteria
ce of other known neurological diseases. (2)Clinical or
al signs of involvement of brain matter. (3)H/O trauma to
d. (4)H/O radiation to the spine in previous 10 years.
page 2 / 3
PDF of Trial
Timepoints
MONTHLY FOR 6 MONTHS
Timepoints
At admission and end of 6 months

ME OF ACUTE NONCOMPRESSIVE
RECRUITED AS PER
DE COMPRESSIVE ETIOLOGY AND
RED BY DISABILITY
THEL ACTIVITY INDEX) ON
page 3 / 3
PDF of Trial
04:51:53 GMT)
mone Refractory Prostate Cancer
provide early access to cabazitaxel in

previously treated with a
azitaxel in these patients
Identifier
Identifier
Protocol Number
ClinicalTrials.gov
Vaid
t
Cancer Institute,
edical and Hemato Oncology, Medanta Cancer Institute,
Cancer Institute, Medanta The Medicity, Sector 38,
122001, Haryana, India
35
id@Medanta.org
Chodankar
dvisor Clinical Research
entis
ntis House, Sir Mathuradas Vasanji Road, Andheri East
SHTRA
13
odankar@sanofi-aventis.com
Chodankar
ntis House, Sir Mathuradas Vasanji Road, Andheri East,
SHTRA
page 1 / 5
PDF of Trial
13
odankar@sanofi-aventis.com
asanji Road, Andheri (E), Mumbai

nthelabo India Limited
huradas Vasanji Road, Andheri East, Mumbai
Address

t of Radiotherapy and francisvjames@hotmail.
Oncology, Medical
page 2 / 5
PDF of Trial
College Campus, com

Trivandrum-695011
Thiruvananthapuram
KERALA
Dept of Oncology, 2nd 9840077722
nt of floor, Consultation room rnimmagadda@yahoo.c
no. 23 Padma complex, om
Anna Salai,Mount
road,Chennai-600035
Chennai
TAMIL NADU
Dept of Medical and 9810212235

Hemato Oncology, ashok.vaid@medanta.o
o Medanta The Medicity, rg
a The Sector
38,Gurgaon-122001,
Gurgaon
HARYANA
er Department of Urology, 9810139757

h D block Basement, old dr_rawal@hotmail.com
t of building, Sector 5,
Rohini, Delhi-110085
New Delhi
DELHI
l, Dept. Of Urology,3rd 9818024013

ogy floor blood bank nayankm@yahoo.co.in
building, Safdarjang
Hospital, Sri Aurobindo
Marg,-110029
New Delhi
DELHI
pital, Room no. 51 ,Urology 9820073911

nt dept, ground floor Dr. htongaonkar@gmail.co
B.E.Borges Road, m
Parel, Mumbai-400012
Mumbai
MAHARASHTRA

Committee?
Committee?
13/04/2011 Yes
06/04/2011 Yes
15/06/2011 Yes
21/02/2011 Yes
09/02/2011 Yes
page 3 / 5
PDF of Trial
02/05/2011 Yes
Date
05/05/2011
Condition
Malignant neoplasm of prostate
Mestatic Hormone Refractory Prostate Cancer
ame Details
abazitaxel 25 mg/m Cabazitaxel 25 mg/m
intravenously every 3 weeks, in
combination with oral
prednisolone 10 mg daily for 35
weeks
L NIL
Inclusion Criteria
ar(s)
ar(s)
usion criteria: - Age ≥18 years -
c Hormone Refractory Prostate Cancer previously treated
cetaxel-containing regimen - Disease Progression
after docetaxel-containing regimen for mHRPC -
r medical castration - Eastern Cooperative Oncology
COG) Performance Status (PS): 0-2 - Life-expectancy
months - Adequate bone marrow, liver, and renal
Neutrophils 1500 /mm3; Hemoglobin 10 g/dL; Platelets 100
lirubin ULN; SGOT (AST) 1.5xULN; SGPT (ALT) 1.5xULN;
e 1.5xULN - Signed written informed consent obtained
nrollment " 
Exclusion Criteria
lusion criteria:
iotherapy to ? 40% of bone marrow
ionuclide therapy (samarium-153, strontium-89, P-32?)
gery, radiation, chemotherapy, or other anti-cancer therapy
eeks prior to enrollment
rade ?2 peripheral neuropathy
rade ?2 stomatitis
fection requiring systemic antibiotic or anti-fungal
n
ancer (other than mHRPC) including prior malignancy from
patient has been disease-free for ?5 years (except
l non-melanoma skin cancer)
brain or leptomeningeal involvement
of severe hypersensitivity reaction (?grade 3) to docetaxel
of severe hypersensitivity reaction (?grade 3) to polysorbate
ning drugs
of severe hypersensitivity reaction (?grade 3) or intolerance
one or prednisolone
olled severe illness or medical condition (including
ed diabetes mellitus)
ent or planned treatment with potent inhibitors or inducers
ome P450 3A4/5 (a one week wash-out period is
y for patients who are already on these treatments)
ation in a clinical trial with any investigational drug
page 4 / 5
PDF of Trial
with reproductive potential not implementing accepted and

method of contraception
Timepoints
up to 30 weeks
Timepoints
35 weeks
on 20th December 2010 and planned

cted in 28 Countries ARGENTINA,
ZECH REPUBLIC, FINLAND, France,
LAYSIA, MEXICO, PHILIPPINES,
UTH AFRICA, SPAIN, SWEDEN,
- Planned date of first enrolment - 17th
page 5 / 5
PDF of Trial
04:52:00 GMT)
nd Sildenafil - for the treatment of
Combination of Dapoxetine
-existing Erectile Dysfunction and
Identifier
Protocol Number

V Tendulkar
- Medical
harmaceuticals Ltd,
o. 255/2, Phase I, Rajiv Gandhi IT Park, MIDC, Hinjewadi,
SHTRA
1000
1019
ndulkar@emcure.co.in
V Tendulkar
- Medical
harmaceuticals Ltd,
SHTRA
1000
1019
V Tendulkar
- Medical
harmaceuticals Ltd,
SHTRA
page 1 / 5
PDF of Trial
1000
1019

harmceuticals Ltd Pune
o. 255/2, Rajiv Gandhi IT Park,Phase I, MIDC,
Pune-411 057
Address
114, Span Trade 079-26577914

Centre, Opposite dr_rohan291@rediffmai
Kochrab Aashram, l.com
Near Paldi Cross Road,
Ellisbridge, Ahmedabad
Ahmadabad
GUJARAT
s 306, Sangini Complex, 079-26465722

Near. Doctor niyatide@gmail.com
House,,Piramal
Garden, Ellis
Bridge,-380006
Ahmadabad
GUJARAT
Gate No. 6, Opposite 022-22908654

Holy Angle School, drvinesh123@gmail.co
Malwani, Malad (West) m
Mumbai (Suburban)
MAHARASHTRA
al 103, 104 Karnavati 079-26578889

Hospital Building, drmrugesh@rediffmail.c
Opposite Town Hall, om
Ellisbridge, Ahmedabad
- 380006
Ahmadabad
GUJARAT
ic & B/104, Priya Aprtments, 022-28644218

Main Carter Road, drketanparmar@vsnl.ne
Borivali (East), Mumbai t
Mumbai (Suburban)
MAHARASHTRA

Committee?
21/11/2011 Yes
page 2 / 5
PDF of Trial
12/11/2011 Yes
10/12/2011 Yes
10/12/2011 Yes
30/11/2011 Yes
Date
21/10/2011
Condition
Co-existing Erectile Dysfunction and Premature
Ejaculation
ame Details
xed dose combination of One tablet of Fixed Dose
apoxetine Hydrochloride 30 Combination is to be taken
g and Sildenafil Citrate 50 mg approximately 1 hour prior to
ablet sexual activity. (Maximum
dosing frequency is once in
every 24 hours). Duration of
treatment is 4 weeks.
acebo tablet similar to TEST One tablet of the placebo similar

blet to Test is to be taken
approximately 1 hour prior to
sexual activity (Maximum
dosing frequency is once in
every 24 hours. Duration of
treatment is 4 weeks.
Inclusion Criteria
ar(s)
ar(s)
bjects between 18 to 64 years of age. 2.Male subjects

e, monogamous, heterosexual relationship for at least 6
nd expected/planned to maintain this relationship for
f study. 3.Subjects meeting with diagnostic criteria for
ysfunction (as per the international index of erectile function
re lesser than or equal to 25; as specified in Urology 1999,
51). 4.Subjects meeting with diagnostic criteria for
e ejaculation (PE score greater than or equal to 11) as
n article published in European Urology 2007, 52:
 5.Subject and his partner agreeing to attempt sexual
e 2 times/ week. 6.Subject willing to give written
consent and willing to comply with trial protocol. 
Exclusion Criteria
Exclusion Criteria
s events or other conditions associated with premature
n/erectile dysfunction including but not limited to spinal
pelvic surgery.
s with genital anatomical deformities including but not
penile deformities.
s with erectile dysfunction or premature ejaculation due
n withdrawal.
dysfunction in female partner, painful intercourse, partners
eased interest in intercourse or other forms of sexual
page 3 / 5
PDF of Trial
on.
s with major psychiatric illness or previous suicidal
s with history of epilepsy

s with history of stroke, myocardial infraction, heart failure,
angina, life-threatening arrhythmia and hypotension with in
nths.
s for whom sexual activity is inadvisable because of their
disease status.
is a known case of autonomic neuropathy, retinitis
sa, bleeding disorders, sickle cell anemia and active peptic
ase.
ts with significant and uncontrolled
gical/metabolic/ endocrinologial/respiratory/cardiovascular/n
al/psychiatric/liver/kidney diseases.
ts with resting hypotension (BP 90/50) or hypertension (
10)
ts with history of hypersensitivity to SSRI, SNRI,
iesterase inhibitors and constituent of test product.
ts with cardiac arrhythmia or any clinically significant
ty on ECG.
ts with previous history of bone marrow depression.
ts taking concurrent drug therapies OR within last 14 days
inuing treatment with : Monoamine oxidase inhibitor
Thioridazine, Selective serotonin reuptake inhibitor (SSRI),
norepinephrine reuptake inhibitor (SNRI), serotonergic
/herbal products, tricyclic antidepressants, and atypical
otics
ts taking concurrent treatment of: nitrates, alpha blockers,
ors, ketoconazole, itraconazole, ritonavir, saquinavir,
cin, nefazadone, nelfinavir, atazanavir, cimetidine,
cin, clarithromycin, fluconazole, amprenavir,
navir, aprepitant, verapamil, diltiazem, any vasodilators,
et, anticoagulants, dapoxetine, PDE5 inhibitors, alcohol and
recreational drug.
other form of therapy (Pharmacological/ Behavioral) for
ysfunction/ premature ejaculation.
ts who will receive some other drug during the study
hat in the protocol that could alter the pharmacokinetic/
dynamic profile of the study drug.
ts with alcohol or drug abuse.
ndition that, in the opinion of the investigator, does not
patients inclusion in the study.
Timepoints
After 2 weeks and 4 weeks of treatment
Timepoints
At baseline, after 2 and 4 weeks of therapy
page 4 / 5
PDF of Trial
At baseline, after 2 & 4 weeks of therapy

anned to evaluate efficacy and safety of

ildenafil Citrate Tablet in treatment of
Subjects satisfing inclusion and
reference group respectively. Baseline
l be evaluated for primary and
er 4 weeks of therapy. Laboratory
y.
anned to evaluate efficacy and safety of
ildenafil Citrate Tablet in treatment of
Subjects satisfing inclusion and
reference group respectively. Baseline
l be evaluated for primary and
er 4 weeks of therapy. Laboratory
y.
page 5 / 5
PDF of Trial
04:52:10 GMT)
tment in Adolscent patients with
Safety and Tolerability of Flexible-Dose

n Adolescent Patients with
I Disorder, Manic or Mixed Episode
Identifier
Protocol Number
ClinicalTrials.gov

Shinde
anager, Clinical Operations
India Pharmaceutical Services Pvt. Ltd.
India Pharmaceutical Services Pvt. Ltd. Unit No. 1531-41,
r, Dev Corpora, Pokhran Road No.1, Eastern Express
Opposite Cadburys,Thane, Maharashtra, Mumbai, INDIA
SHTRA
284822
284952
nde@covance.com
Shinde
anager-Clinical Operations India
India Pharmaceutical Pvt. Ltd.
017, Trade Centre Bandra-Kurla Complex, Bandra(East)
SHTRA
page 1 / 8
PDF of Trial
700462
700665
nde@covance.com
n, Inc. 2440 Research Boulevard

harmaceutical Development and Commercialization Inc
earch Boulevard Rockville Maryland 20850 United stares
Address
Unit No. 1531-41, 15th Floor, Dev Corpora,
Pokhran Road No.1, Eastern Express Highway,
Opposite Cadburys,Thane, Maharashtra,
Mumbai, INDIA 400601
ical Department of 91-824-2212290

Psychiatry, NH-17, 91-824-2212290
Kuntikana, drnithins@hotmail.com
Mangalore-575004
Karnataka, India
Bangalore Rural
KARNATAKA
our Department of 91-891-2713545

Psychiatry, 201, MVV 91-891-2713545
Chambers, Opp King drramanand@yahoo.co
George Hospital, .in
Maharani Peta,
Visakhapatnam-530
002, Andhra Pradesh,
India
Visakhapatnam
ANDHRA PRADESH
pital Department of 91-79-2435283

Psychiatry, Dhiraj 91-79-2435283
General Hospital, sandeephshah@hotmai
Pipariya – Waghodia l.com
Road,
Vadodara
GUJARAT
Delhi Psychiatry 91-11-43666666

page 2 / 8
PDF of Trial
e 91-11-40629960
sunil.manu@gmail.com
91-161-2300643
91-161-2300643
drnavkiran@yahoo.co.i
n
91-20-40151000
wan 91-20-25420104
sanjay_phadke@hotma
il.com
91-821-2442840
uja 91-821-2442840
tssrao19@yahoo.com
ment, 91-512-2233838
a 91-512-2242034
005 rkmahendru@indiatime
s.com
91-824-2443973
ircle, 91-824-2445034
ravishthunga@yahoo.c
om
91-141-2520506
91-141-2520113
viya dr.tambianil@yahoo.in
91-79-27551755
91-79-27551755
anti mahesh_mitr@yahoo.c
y of o.in
m
-
gya 91-79-26575216
nt of 91-79-26576652
dge hitengandhi@yahoo.co.
in
x, 91-79-26578455
al,,Ell 91-79-26588055
lakshmandutt1@indiati
mes.com
91-9811033032
91-9811033032
page 3 / 8
PDF of Trial
Neurology, IV Floor, jmwadhwa@yahoo.co.i

Rajinder Nagar New n
Delhi-110 060, India
New Delhi
DELHI
Birla Hospital & Department of 91-9822039737
al research center Psychiatry,Opp Bytco 91-9822039737
College ,Nasik pune drbsvprasad@gmail.co
highway, Nasik- m
422101, Maharashtra,
India
Nashik
MAHARASHTRA

Committee?
01/07/2011 No
29/09/2011 No
06/12/2010 Yes
26/11/2011 No
28/12/2011 No
14/11/2011 No
18/10/2011 No
23/05/2011 Yes
28/08/2011 No
29/10/2010 No
23/06/2011 No
28/05/2011 No
26/05/2011 No
page 4 / 8
PDF of Trial
24/11/2011 No
21/10/2010 No
Date
21/11/2011
Condition
Screening of Schizophrenia in Adolscent Patient
ame Details
ipiprazole Treatment in Adolescent
aripiprazole monotherapy at a
dose of 10 to 30 mg/day can
enter Phase 2 on their current
dose of aripiprazole after
completing the screening period
and Phase 2 baseline visit. • De
novo subjects who are currently
treated with lower doses of
branded aripiprazole (ie, 10
mg/day) can enter Phase 2 on
their current dose of
aripiprazole. Doses should then
be increased following the
procedure listed on the titration
schedule card until a dose of at
least 10 mg/day is achieved
after Day 6. However, their dose
may be decreased to 5 mg/day
due to any tolerability issues
during Phase 2, after Day 6.
The treatment trial duration is
2.5 Years
Inclusion Criteria
ar(s)
ar(s)
specific written informed consent/assent obtained from

acceptable representative (eg, guardian), prior to the
of any protocol-required procedures. In addition, the
ust provide informed assent at screening and as such
ble to understand that he or she can withdraw from
at any time. All informed consent/assent procedures
n accordance with the study center?s institutional
ard/ethics committee (IRB/IEC) and local regulatory
ents. If the roll-over subject should turn 18 years of
n 4 weeks prior to entry into Study 267 or during Study
participation, an informed consent must be obtained
the subject. 2) Adolescent male and female subjects
 ? De novo subjects aged ≥ 13 to < 17 years
subject must have passed his or her 13th birthday but
ached their 17th birthday at the time of signing the
page 5 / 8
c.in
PDF of Trial
y, after successfully completing screening, will enter

br/> directly (bypassing Phase 1) on the same dose that
br/> currently receiving and starting a titration to a
 10 mg/day dose during the first week of Phase
3) Adequate washout of prohibited concomitant
ns prior to entry into Phase 2, including ≥ 14
mood stabilizers, ≥ 14 days for antidepressants,
1 cycle plus 14 days for marketed long-acting
otics (eg, 2-week cycle plus an additional 14 days for
e long-acting injection), and ≥ 60 days prior to
for investigational long-acting antipsychotics
Table 4.1-1). 14) Subjects who are receiving no more
nzodiazepine after screening. NOTE: If a subject is
 2 benzodiazepines at screening, attempts should be
br/> discontinue 1 of them, if clinically warranted, to
> potential subjects to enter the study. The second 
zepine should be tapered off over an appropriate 
time within the established duration of the screening
prevent any withdrawal effects, and the subject should
ined on the remaining benzodiazepine for at least 14
to the first dose of study medication in Phase 2.
Exclusion Criteria
y active males who are not practicing doublebarrier birth
who will not remain abstinent during the study and for 90
wing the last dose of study medication, or sexually active
f
ng potential who are not practicing doublebarrier birth
who will not remain abstinent during the study and for 30
wing the last dose of study medication. Abstinence will be
if it is
and documented at every study visit. If
g birth control, 2 of the following precautions must be used:
y, tubal ligation, vaginal diaphragm, intrauterine device
h control pill,implant, condom or sponge with spermicide.
es who are breast-feeding and/or who have a positive
egnancy test result prior to receiving study drug. Target
s with and Axis I (DSM-IV-TR) diagnosis for schizoaffective

or a current diagnosis of major depressive disorder.
ts with a clinical presentation and/or history that is
t with delirium, dementia, amnesia or other cognitive
subjects with psychotic symptoms that
accounted for by another general medical condition(s) or
ct of a substance (ie, medication,illicit drug use, etc.).
urological disorder, with the exception of Tourette?s
.
ts experiencing acute depressive symptoms within the past
rior to screening that require treatment with an
ssant, according to the investigator?s
ts with schizophrenia that is Considered treatment

o antipsychotic medication, including relapse while on
doses of aripiprazole, by history.
ts with a history of failure of clozapine treatment or
to clozapine treatment only.
page 7 / 8
PDF of Trial
Timepoints
Screening Visit
Baseline visit
Weekly visit Phase 1 Wk 1 - Phase 1 wk 6
Phase 2
Baseline visit
Weekly visit Phase 2 Wk 1 - Phase 2 wk 4
Biweekly visit Phase 2 week 6 , Phase 2 wk 8
Months 3, 4 ,6,9,12,15,18,21 Visit Months 5, 7,
8, 10, 11, 13,14, 16, 17, 19, 20,22, 23 Phone
Contact End of Study (Month 12 or 24)
Timepoints
2.5 YEARS
oral dose of oral Aripiprazole on

page 8 / 8
PDF of Trial
04:52:20 GMT)
findings in Guillain-Barre syndrome;
indings in Guillain-Barre syndrome;
Identifier
NIL
NAPHADE
RESIDENT, NEUROLOGY
MENT OF NEUROLOGY, CSM MEDICAL

ITY(KGMC), CHOWK, LUCKNOW
RADESH
852
852
phade@yahoo.com
K GARG
and head
F NEUROLOGY, CSMMU (KGMC), LUCKNOW SAME
RADESH
852
852
yahoo.com
K GARG
and head
F NEUROLOGY, CSMMU (KGMC) CHOWK
RADESH
852
852
page 1 / 3
PDF of Trial
yahoo.com

DICAL UNIVERSITY LUCKNOW
CAL COLLEGE LUCKNOW. UP. INDIA 622001
ent medical college
Address
NIL

CSM MEDICAL 05222258852
UNIVERSITY, 05222258852
KGMC,LUCKNOW UP, pravin_naphade@yaho
INDIA 622001 o.com
Lucknow
UTTAR PRADESH

Committee?
24/04/2010 Not Available
Date
No Date Specified
Condition
Guillain-Barre syndrome
ame Details
(s)
ar(s)
with clinical and electrophysiological diagnosis of Guillain

drome according to Asburys and Albers criteria 
Exclusion Criteria
aving other causes of bladder symptoms
n mechanical ventilation
Timepoints
AT 2 MONTHS
page 2 / 3
PDF of Trial
Timepoints
AT 2 MONTHS
Barre syndrome. But as autonomic

supplied by this, it is expected to be
ent and will assess them
isability.
page 3 / 3
PDF of Trial
04:52:26 GMT)
n patients with acute ischemic stroke
uate efficacy and safety of R-TPR-004
Identifier
Protocol Number
Kosgi
S clinical Trial
Life Sciences Pvt.Ltd
Ambani Life Sciences Centre R-282 TTC Area of MIDC
avi Mumbai
SHTRA
000
299
sgi@relbio.com
anjula
cal Pharmacology
Life Sciences Pvt Ltd
Clinical Research Services, Reliance Life Sciences Pvt.
TOWERS, # 65-373-2, 100 ft., Ring Road,BTM Layout 2nd
e
AKA
116
196
ula@Relbio.com
Kosgi
LS Trials
Life Sciences Pvt. Ltd., Dhirubhai Ambani Life Sciences

ot R-282 TTC Area of MIDC, Rabale
SHTRA
page 1 / 5
PDF of Trial
-8258
299
sgi@relclin.com
ences Centre Plot R-282, TTC Area of

Life Sciences Pvt Ltd
Ambani Life Sciences Centre R-282 TTC Area of MIDC
lapur Road Rabale Navi Mumbai 400 701
Address
al Neurology, Christian neuroyash@yahoo.co.i
Medical College & n
Hospital, Brown Road,
141008
Ludhiana
PUNJAB
1, Maharashtra Society, 9824041187

Nr. Mithakhali Six dr.bashir52@gmail.com
Roads, Opposite Lions
Hall, Ellisbridge 380
006
Ahmadabad
GUJARAT
ge Department of 08212548363
Neurology l Ramanuja keshavabelur@gmail.co
Road Mysore 570004 m
Mysore
KARNATAKA
ar JNMC Campus, Nehru 08312478777

Nagar, krnaik60@yahoo.com
Belguam-590010
Belgaum
KARNATAKA
Kothapet, Guntur - 522 08632222866

al 001 Drviiaya.lssh@gmail.co
Guntur m
ANDHRA PRADESH
Gokula Metropolis 9448040589
Clinical Research drrsrinivasa@hotmail.c
Center, New BEL Road, om
MSRIT Post, 560054
Bangalore
KARNATAKA
4th Floor Department of 01125751111

Neurology, Sir Ganga rohatgianshu@yahoo.c
Ram Hospital Marg, Old
page 2 / 5
PDF of Trial
Rajinder Nagar, 110060 om

New Delhi
DELHI
Dept of Neurology, 3rd 08022065330
Floor, Sarjapur Road, grk_sarma@yahoo.com
560034
Bangalore
KARNATAKA
ral Erragadda 9866960555

Sanathnagar, drvikramsharma@gmail
Hyderabad, 500018 .com
Hyderabad
ANDHRA PRADESH
r Department Of 9820747496
Neurology, Dr. A. L. nairneurology@gmail.c
Nair Road, Opp. om
Maratha Mandir,
Mumbai Central,
Mumbai- 400008
Mumbai
MAHARASHTRA

Committee?
24/01/2013 No
22/04/2013 No
07/05/2013 No
04/02/2013 No
No Date Specified No
10/04/2013 No
13/12/2012 No
15/12/2012 No
Date
04/03/2013
page 3 / 5
PDF of Trial
Condition
Acute Ischemic Stroke
ame Details
ssue plasminogen activator Dose: 7 ml (7 units) Duration:
med as R-TPR-004 Upto 24 hrs. Frequency: First
dose 7 ml (7U)at 0 min Second
dose 7 ml (7U)at 30 min Mode
of administration: Slow
intravenous (IV) bolus over 2
minutes
ot Applicable Not Applicable

Inclusion Criteria
ar(s)
ar(s)
with Ischemic Stroke of 4.5 hours of symptom onset. 
s with normal or slight early CT signs of ischemic
r/> 3. Women of child bearing potential having a negative
y test and taking adequate birth control measures. 4.
rom Legally Acceptable Representative (LAR), if subject is
condition to give consent. However, when the subject is
d is able to give consent, consent would be obtained on a
CF to confirm his/her willingness to continue in the
>
Exclusion Criteria
with h/o Recent Stroke 110 mmHg (mean of 3 consecutive
eadings over 20-30 minutes), not controlled by
ensive therapy or requiring nitroprusside for control.
ce or h/o intracranial neoplasm or arteriovenous
ion, intracranial aneurysm, unless surgically treated ?3
urgery, serious trauma, lumbar puncture, arterial puncture

ompressible site, or biopsy of a parenchymal organ in last
Major surgical procedures include but are not limited to the
major thoracic or abdominopelvic surgery, neurosurgery,
b surgery, carotid endarterectomy or other vascular
nd organ transplant).
l history or evidence of HIV, HBV and HCV infection.
participation in another clinical trial 30 days prior to
ation of IP.
ant and lactating females.
ther condition which investigator feels would pose a
hazard to
IP is administered.
Timepoints
Neurological improvement in patients as
assessed by decrease (improvement) in NIHSS
scores from baseline to 24 hrs.
Timepoints
page 4 / 5
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Decrease in Modified Rankin Scale (mRs) score

from baseline to 1 and 3 month.
Evaluation of safety will be based on adverse
events, physical exams, vital signs, and safety
laboratory tests during the study
Decrease in Modified Rankin Scale (mRs) score
from baseline to 1 and 3 month.
Evaluation of safety will be based on adverse
events, physical exams, vital signs, and safety
laboratory tests during the study

that it is not feasible to continue

prescribed dose
page 5 / 5
PDF of Trial
04:52:32 GMT)
ost-Herpetic Neuralgia. (Post-herpetic

ction of herpes zoster (shingles).
ost-Herpetic Neuralgia. (Post-herpetic
ction of herpes zoster (shingles).
Parallel-Group, Multicenter Clinical
.
Identifier
Protocol Number
ClinicalTrials.gov

driyal
Director
maceutical Development (I) Pvt.Ltd, Vatika City Point, 11th

or 25, Mehrauli Gurgaon Road
739903
739999
driyal@ppdi.com
driyal
Director
maceutical Development India Pvt. Ltd. Vatika City Point,

Sector 25, Mehrauli Gurgaon Road
739903
page 1 / 6
PDF of Trial
739999
driyal@ppdi.com
artado 19, 4745-457 S. Mamede do

la C SA
a Siderurgia Nacional, Apartado 19, 4745-457 S. Mamede
ado, Portugal
Address
01-Dynasty B-Wing (Kanakia Spaces),
Andheri-Kurla Rd. Andheri East,
Mumbai-400059. India
er P. B. No. 3209, +91 422 4323202

Avanashi +91 422 2627782
Road,,-641014 kalyani_vijayan@rediff
Coimbatore mail.com
TAMIL NADU
e, Room No. 1 & 2, OPD +91 9841183019

Block, 175, ,NSK Salaj doc_suresh@yahoo.co
Vadapalani, -600026 m
Chennai
TAMIL NADU
, # 502, Academic Block, +91 11 23234350
Department of +91 11 23234350
Neurology, ,Jawaharlal mmehndi@hotmail.com
Nehru Marg, -110002
New Delhi
DELHI
314/30, Mirza Mandi +91 94150260541

Chowk,,-226003 +93 0522 4079157
Lucknow sandeepkumar.gupta@
UTTAR PRADESH rediffmail.com
rch, No. 416, 4th Cross, 2nd +91 9880101778

Block, ,Kalyan +91 80 254 59006
Nagar,-560043 sunureg@yahoo.co.in
page 2 / 6
PDF of Trial
Bangalore
KARNATAKA
Department of +91 141 4075120
Neurology,,Jawahrlal +91 141 510118 5
Nehru Marg-302004 sharmadrbhawna@gma
Jaipur il.com
RAJASTHAN
VF 765, ABC +91 9936507362

Complex,Kanpur Road, +91 522 465223
Alambagh,-226005 drdeepakdewan@rediff
Lucknow mail.com
UTTAR PRADESH

Committee?
10/08/2010 Yes
01/09/2010 Yes
20/08/2010 No
15/09/2010 No
13/08/2010 No
15/07/2011 No
29/10/2010 No
Date
18/03/2011
Condition
Post-Herpetic Neuralgia
ame Details
slicarbazepine acetate 800 mg Eslicarbazepine acetate 800 mg
ce daily (QD)(Oral Tablets) once daily (QD): Experimental
19 weeks (Blinded phase)
followed by optional open label
36 weeks
slicarbazepine acetate 1200 Eslicarbazepine acetate 1200

g QD (Oral tablets) mg QD: Experimental 19 weeks
(Blinded phase) followed by
optional open label 36 weeks
slicarbazepine acetate 1600 Eslicarbazepine acetate 1600

g QD (Oral Tablets) mg QD: Experimental 19 weeks
(Blinded phase) followed by
optional open label 36 weeks
acebo: Placebo Comparator Drug: Placebo Comparator 19

ral Tablets) weeks (Blinded phase)
page 3 / 6
PDF of Trial
Inclusion Criteria
ar(s)
ar(s)
nd female outpatients aged 18 years or older. Female
are of nonchildbearing potential, defined as surgical
n (hysterectomy or bilateral oophorectomy or tubal ligation)
2 years postmenopausal (spontaneous amenorrhea for at
months before Visit 1), or if of childbearing potential,
agree to use a medically acceptable nonhormonal method
eption. 2. Experiencing pain for at least 6 months
healing of a herpes zoster skin rash. 3. A mean score
4.0 and 9.0, inclusive, on the 24 hour average pain intensity
ent. 4. Compliance with patient diary completion.
not used to treat PHN, subjects are permitted to take
dal anti inflammatory drugs and selective serotonin
nhibitors if they were kept on a stable dose for 1 month
creening and are foreseen to remain stable throughout the
/> 6. Competent and able to freely give own informed
 7. Female subjects of childbearing potential, who are
ntly breastfeeding, must have a negative serum pregnancy
it 1. Note: There is no upper age limit/restriction for
or exclusion in the study.
Exclusion Criteria
al exposure to drugs known to cause neuropathy
ant skin lesions (active infection, ulcer, etc).
intolerance to ESL or to other carboxamide derivatives (eg,
epine or oxcarbazepine) or frequent or severe allergic
with multiple medications.
s who previously participated in a clinical study with ESL.
sychiatric disorder.
s or unstable cardiovascular disease that could compromise
on or cause hospitalization during the study.
d or third degree atrioventricular blockade not corrected with
ker or any clinically significant abnormality in the 12 lead
diogram as determined by the investigator.
s taking the following drug classes and individual drugs are
benzodiazepines (except short half life sleep agents),
muscle relaxants, orally administered steroids, capsaicin,
e, centrally acting analgesics (dextromethorphan, tramadol),
opical lidocaine, anticonvulsants, tricyclic antidepressants,
onin norepinephrine reuptake inhibitors. These drugs
minimum washout period of at least 5 times the half life and
tapered appropriately using product label instructions as a
nt clinical laboratory abnormality that, in the investigators

an compromise the subjects safety.
y of drug abuse or dependence (drug categories defined by
within the past year, excluding nicotine and caffeine.
cts who, in the previous 30 days, received treatment with a
had not received regulatory approval for any indication at
f study entry.
y of recurrent epileptic seizures except febrile seizures.
y of severe gastroparesis or gastric bypass surgery.
lytic or neurosurgical treatment for PHN.
ed anesthetics or steroid use within 30 days of Visit 1.
nancy within past 2 years.
y of chronic hepatitis B or C within the past 3 months or
munodeficiency virus infection.
page 4 / 6
PDF of Trial
Timepoints
Time Frame: 12 weeks The primary efficacy
variable will be based on the response to a
11-point Numerical Rating Pain Scale (NRPS)
relating to pain intensity. This will be used to
generate the primary efficacy variable of change
from Baseline to endpoint in mean pain.
Timepoints


page 5 / 6
PDF of Trial
ain following an acute infection of

mal. More than 50% of the subjects fail
lerable side effects. The clinical
chemical and pharmacodynamic
epine, which is effective for treating
the theoretical background. This study
netics of Eslicarbazepine acetate for the
nvestigate the effect of 3 ESL doses
with placebo.
page 6 / 6
PDF of Trial
04:52:40 GMT)
patients with partial seizures

olled, randomized study: evaluation of
y in participants (? 17 to 70 years old)
Identifier
Protocol Number
ClinicalTrials.gov
UTN
darajulu
nsultant-Neurology
adarajulu No 416, 4th Cross, 2nd Block, Kalyan Nagar

e Karnataka - 560 043 India No 416, 4th Cross, 2nd Block,
agar
e
AKA
01778
791001
uludr@gmail.com
upta
Monitor
man International Ltd.
man International Ltd. Max House, 1st Floor 1, Dr Jha
hla - III
i
87654
001945
emanasia.com
Anwar
Operations
man International Ltd. Max House, 1st Floor 1, Dr Jha
hla - III New Delhi - 110 020 Max House 1, Dr. Jha Marg,
ase III
page 1 / 9
PDF of Trial
15
791001
neemanasia.com
y West Eatontown, NJ 07724, USA
A AlZubaidy Vice President Operations
p, Inc. 248 Latitude Lane, Suite 104 Lake Wylie, SC
57 Phone: 803-831-1457 Cell: 516-480-8737
831-1494
esearch organization
Address
Max House, 1, Dr. Jha Marg, Okhla Phase-III
City: New Delhi State: New Delhi Postal Code:

Address Line 1: Adhit 91-9845308734
ntre Kiran Neuropsychiatry 91-824-4250400
centre, Address Line 2: drkirana@hotmail.com
Millenium Towers,
Opposite Highland
Hospital, Highland
Mangalore City:
Mangalore State:
Karnataka Postal Code:
Bangalore
KARNATAKA
al& B.P. Poddar Hospital& 91-9830413617

b Medical Resarch lab 91-33-23997009
71/1 Humayun Kabir drscmukherjee@gmail.
Sarani, Block G, New com
Alipore City:
Kolkata-700053,India
Kolkata
WEST BENGAL
rch Bangalore 09880101778

Clinisearch,No 416, 4th 91-80-41791001
Cross, 2nd Block, varadarajuludr@gmail.c
Kalyan Nagar, om
Bangalore-560 043,
Karnataka,India
Bangalore
KARNATAKA
cal Dr. Gaikwad’s Critical 9823018361
page 2 / 9
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gaikwadhospital@ymail
.com
,
ode
91-9096050839
20/1, 91-712-6645017
pkshembalkar@hotmail
.com
91-9901782100
5th 91-80-26755903
st drsanthoshdv@gmail.c
olg, om
60
a
09373037703
, neurologist@hotmail.co
.in
ng 91-9849127576
91-891-2714644
ar neuromadhu@gmail.co
m
tate:
ostal
ntry:
91-9320361266
ai 91-22-30972030
jayanti.mani@reliancea
da.com
ine
tate:
l
ntry:
orial 91-80-40528405
L 91-80-40528402
h drrsrinivas@hotmail.co
t, m
ia
page 3 / 9
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di 91-9005621715
tar 91-522-4016051
gargneeta_vs@yahoo.c
o.in
le, 91-9845080925
91-824-4255925
ka shankarmal@hotmail.c
om
al & 91-20-66023000
rand 91-20-66023107
ashtr rahulneuro@vsnl.net
9971545666
x 011-26514040
pgpuneet@gmail.com
et,
te:
dica 91-9831599727
91-33-24264967
7, mandal_amlan@yahoo.
co.in
ata
99
91-79-26467467
gini 91-79-26405758
mal drshalinshah@yahoo.c
e, o.in
CE 91-9743503223
91-80-41626643
. 53, nithinkumar_n@yahoo.
com
r
wadi,
te:
ode:
dia
1 0124-4585555
page 4 / 9
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Block, Sushant Lok, rajnishkumar16@yahoo

Phase-I, Sec-43, .co.in
Gurgaon-
122002,Haryana
Gurgaon
HARYANA
PSG Hospitals, Peelam 91-9894995380

edu,Coimbatore-64100 91-422-2594400
4 ,Tamil Nadu ramneuro@yahoo.com
Coimbatore
TAMIL NADU
Ruby Hall Clinic,40, 91-20-26123391

Sassoon Road-411001 91-20-26124529
Pune drrswadia@gmail.com
MAHARASHTRA
Shatabdi Super 9960005088

speciality Hospital dr_andu@rediffmail.co
Suyojit City Centre, m
Opp Mahamarg Bus
Stand, Mumbai Naka,
Pin Code – 422005,
India
Nashik
MAHARASHTRA
St Johns Medical 09341959674

College Hospital, Dept 91-80-25634479
of Neurology, Sarjapur grk_sarma@yahoo.com
Road, Koramangala,
Bangalore-560034,
Karnataka, India
Bangalore
KARNATAKA
ality Vedant Multi Speciality 9370134202
h Hospital & Research Pujara.bhavin@yahoo.c
Centre S-3, 2nd Floor, om
Vedant Commercial
Complex Vartak Nagar,
Thane, Pin Code -
400606
Mumbai
MAHARASHTRA

Committee?
20/11/2010 No
05/10/2010 Yes
29/10/2010 Yes
17/05/2011 No
14/03/2012 Yes
page 5 / 9
PDF of Trial
Yes
Yes
Yes
No
No
No
No
No
No
No
Yes
Yes
Yes
page 6 / 9
PDF of Trial
20/07/2011 No
05/01/2011 No
16/11/2010 Yes
23/03/2012 No
31/01/2011 No
Date
06/05/2011
Condition
Simple & Complex Partial Seizure with or without
secondary generalization
ame Details
ab. Phenobarbital Tab. Phenobarbital 15 mg (OD)
with placebo (during the titration
period) Tab. Phenobarbital 30
mg (OD) with placebo (during
the titration period. Tab.
Phenobarbital 60 mg (OD) with
placebo (during the titration
period) Tab. Phenobarbital 100
mg (OD) with placebo (during
the titration period) Route of
Administration: Oral Duration of
Treatment:22 Weeks
acebo Treatment Duration: 22 Weeks

Inclusion Criteria
ar(s)
ar(s)
Criteria: 1) Participants from 17 to 70 years
); 2) Participants with a history of Type-1 partial onset
complex or simple[with motor symptoms only]; according to
sification; 1981)whether or not secondarily
ed; 3) Participants must have had, within the last 10
e electroencephalogram (EEG) or video EEG and/or one
netic resonance imaging (MRI) or computerized
hy (CT) with results consistent with a diagnosis of
set seizures. If these have not been performed in the last
or if the records of these are not available, an EEG and CT
l be performed as part of the screening procedures. 
page 7 / 9
PDF of Trial
pants having at least eight Type-1 partial onset seizures

r not secondarily generalized, during the 8-week Baseline
Participants being uncontrolled while treated by 1 to 3
concomitant AED(s) and/or Vagus Nerve Stimulation (if
t is treated with VNS for at least 6 months prior to the start
dy, this will count as one of the three permitted concomitant
s); 6) Participant has been on a stable dose of their
nti-epileptic treatment regime for at least 1 month prior to
and VNS settings must have been unchanged for at least
Exclusion Criteria
Criteria
y taking phenobarbital or primidone (accepted if they have
or a month prior to study screening);
tly taking felbamate or vigabatrin. All prescription
n excluded except those approved in a similar product in
d States.
of prior allergic reaction to phenobarbital;
or presence of seizures occurring only in clusters (too
or indistinctly separated to be reliably counted) before Visit
ory or presence of status epilepticus during the year
Visit 1 or during baseline;
of psychogenic seizures;
ant taking any drug with possible relevant CNS effects
stable from at least 1 month before Visit 1 and expected to
able during the Treatment Period;
of cerebrovascular accident (CVA), including transient
attack (TIA), in the last 6 months;
ce of any sign (clinical or imaging techniques) suggesting
ogressing (ie, not expected to stay stable during study
on) brain disorder or brain tumor;
nce of unstable arteriovenous malformations, meningiomas
enign tumors. Stable lesions such as these may be
e;
y of porphyria;
nce of clinically significant findings on physical
on, vital signs, electrocardiogram, or safety laboratory
ents, including, but not limited to, either renal or hepatic
cy;
y of alcohol or drug abuse within the year prior to the
visit as defined by DSM IV TR creiteria;
ipant who is known to be non-compliant with their current
anti-epileptic drugs;
ipant is a male or female of child-bearing potential who
use an acceptable form of contraception during the study,
le participant who is pregnant or lactating or participant

become pregnant during the study. (Females who are
sterilized or have been post menopausal for at least 2
not considered to be of child bearing potential). For the
of this study, acceptable forms of birth control include,
rrier methods (e.g. use of condoms and spermicide),
e device, and abstinence with second acceptable method
rticipant become sexually active; or
ipant has taken part in any trial with any investigational
product within the 2 months prior to the screening visit
page 8 / 9
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Timepoints
8 Weeks
Timepoints
8 weeks

roup, placebo-controlled,
safety of phenobarbital as
old) with partial onset
evaluate the efficacy of once
henobarbital, in reducing seizure
es not fully controlled despite
ugs (AEDs) or AEDs with
pation is for 34 weeks and
ountries are India, USA and
a. In India, 175 subjects are to
roup, placebo-controlled,
safety of phenobarbital as
old) with partial onset
evaluate the efficacy of once
henobarbital, in reducing seizure
es not fully controlled despite
ugs (AEDs) or AEDs with
pation is for 34 weeks and
ountries are India, USA and
a. In India, 175 subjects are to
page 9 / 9
PDF of Trial
04:52:47 GMT)
t line monotherapy in patients (>16

alization
e efficacy and safety of levetiracetam as
rtial seizures with or without secondary
Identifier
Protocol Number
hish Chowdhury
of Neurology G.B.Pant Hospital
i
071
hchowdhury@hotmail.com
Naik
nager
althcare Pvt Ltd D-Mart Building, Goregaon Mulund Link
lund (W)
SHTRA
6910
6666
k@piramal.com
Prabhu
althcare Pvt Ltd D-Mart Building, Goregaon Mulund Link

lund (W)
SHTRA
page 1 / 4
PDF of Trial
6910
6666
bhu@piramal.com
on Mulund Link Road Mulund(W)

althcare Pvt Ltd
Address
a Medical College Head Department of 09848190710

Neurology,King George amcneurodept@hotmail
Hospital-530002 .com
Not Applicable
N/A
Professor of 09811458071
Neurology,Associate debashishchowdhury@
Hospital of hotmail.com
MAMC-110002
New Delhi
DELHI

Committee?
Date
No Date Specified
Condition
Partial seizures with or without secondary
generalization
ame Details
vetiracetam 500mg Treatment will be initiated with a
daily dose of 500mg/day, given
as twice daily dosing (250 mg
BID), with or without food. After
two weeks dose will be
increased to 1000 mg/day
(Dose level 1), given as twice
daily dosing (500 mg BID)
Additional dosing increments
may be given (1000 mg/day
additional every 2 weeks ?
Dose level 2) to patients
experiencing seizures at dose
page 2 / 4
PDF of Trial
level 1. Dose can be further

increased to a maximum
recommended daily dose of
3000 mg (Dose level 3),
depending upon the clinical
response and tolerability.
l Nil
Inclusion Criteria
of either sex with established diagnosis of partial seizures

hout secondary generalization. 2.Age above 16 years.
iagnosed or treatment naïve epilepsy patients
o give informed consent (for age above 16 years)
willing to use adequate contraceptive methods
Exclusion Criteria
with seizures other than partial seizures with or without
y generalization. 2.Patients with any progressive brain
3.Patients with history of pre existing behavioral impairment
with hepatic or renal impairment 5.Patients with severe
e respiratory disease 6.Patients with a clinically significant
which needs treatment. 7.Patients with acute intermittent
8.Patients currently on other antiepileptics 9.Patients on
oagulants 10.Patients receiving corticosteroids 11.Patients
griseofulvin 12.Women who are pregnant or conceive
study period
Timepoints
Screening, Baseline , Day 30, Day 180 and Day
360
Timepoints
Screening, Baseline , Day 30, Day 180 and Day
360

page 3 / 4
PDF of Trial
e efficacy and safety of levetiracetam as

rtial seizures with or without secondary
ndia only.60 patients satisfying the
ill be allocated treatment with
on and seizures for period of one year.
m at end of one year treatment period.
page 4 / 4
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04:52:52 GMT)
of bladder tumours namely monopolar
randomized control trial.
Identifier
NIL
hakar Kekre
and Head
nt of Urology
nt of Urology, Christian Medical College, Vellore
ADU
2111
cvellore.ac.in
nkatramani
gistrar
nt of Urology
ADU
1979
@gmail.com
nkatramani
gistrar
nt of Urology
ADU
1979
@gmail.com
page 1 / 4
PDF of Trial

nt of Urology
Medical College, Vellore
institution and hospital
Address
NIL
ogy Christian Medical 076398-31979

College Vellore 632002 docvivek@gmail.com
Vellore
TAMIL NADU

Committee?
27/01/2011 Yes
Date
No Date Specified
Condition
Bladder cancer
ame Details
ame Details
polar trans-urethral resection Gyrus system bipolar cautery to
bladder tumour be used
onopolar trans-urethral Standard monopolar cautery
section of bladder tumour loop to be used
Inclusion Criteria
ar(s)
ar(s)
er tumours udergoing TURT - Patients fit for spinal

a
Exclusion Criteria
unfit for surgery
second TURT at 6 weeks for T1G3 tumour
Timepoints
The outcomes will be measured with 1 month
post-operatively
page 2 / 4
PDF of Trial
Timepoints
Up to 18months from surgery

r/ saline TURT and compare it with the
adder tumours. It involves use of cutting

eturn electrode on the patient. This has
ral damage. Bipolar cautery combines
collateral damage.
nce of TURP however its exact role
med to be significantly safer than
ion i.e. Normal Saline, and has a lower
ists on this subject has shown it to be
y allocated to either group for resection
cle in the specimen and residual
of bladder perforation will be
pared by measuring pre-op and

of saline required for irrigation and
e-procedure and post-procedure
ogist by documenting the degree
page 3 / 4
PDF of Trial
ysis to determine their

page 4 / 4
PDF of Trial
04:52:59 GMT)
e cancer patients
udy to Evaluate Efficacy, Safety And
Prostate Cancer
Identifier
Protocol Number
hiv Bhole
rsing Home and Urology Center, Beside Suretech Hospital,

Nagpur NIL
SHTRA
07
bhole@gmail.com
oshi
Director Medical Affairs & Safety
Director Medical Affairs & Safety
esciences, 802, Building No. 3, Raheja Mind Space(SEZ),
, TTC Industrial Area, Airoli, Navi Mumbai NIL
SHTRA
410
499
@karmiclifesciences.com
hiv Bhole
hiv Bhole
rsing Home and Urology Center, Beside Suretech Hospital,

Nagpur NIL
SHTRA
07
page 1 / 5
PDF of Trial
bhole@gmail.com
02223082891 Fax 02225787855
oad, Mumbai Central, Mumbai, Phone: (022) 23082891

)25787855.
Address
NIL
Medical Oncologist, 9437020880

Acharya Harihar 0671614683
Regional Cancer dillip_ag@yahoo.com
Centre, Mangalbag
Road, Cuttack 753 007,
Orissa, India
Cuttack
ORISSA
pital Medical Oncologist, 0261-2641000
ute Bharat Cancer Hospital 0261-2641004
and Research Institute, tanveermaksud@yahoo
Opp. HP Petrol Pump, .com
Surat Bardoli Road,
Saroli, Surat-395010,
Gujarat, India
Surat
GUJARAT
Surgical Oncologist, 09376913131

Jeevandip Hospital, 0261-6696078
AYUSH Doctor House, gnonco@gmail.com
302, 3rd Floor, Near
Param Doctor House,
Near Resham Bhuvan,
Surat-395 004, Gujarat,
India
Surat
GUJARAT
me Urologist, Ketaki 9822041307

r Nursing Home and -
Urology Center Beside sadashivbhole@gmail.c
Suretech Hospital, om
Dhantoli,Nagpur
440012
Nagpur
MAHARASHTRA
nd Medical Oncologist, 09937500878

Sparsh Hospitals and 06742540189
Critical Care, A/ 407, drgbiswas@yahoo.com
Sahid Nagar,
Bhubaneshwar 751
page 2 / 5
PDF of Trial
007, Orissa, India

Khordha
ORISSA

Committee?
16/03/2011 Yes
16/03/2011 Yes
16/03/2011 Yes
16/03/2011 Yes
02/08/2011 Yes
Date
No Date Specified
Condition
Advanced and/or Metastatic Prostate Cancer
ame Details
calutamide Tablet Bicalutamide 50 mg Tablet once
daily for duration of 180 days.
L NIL
Inclusion Criteria
ar(s)
ar(s)
tial subject willing to give written informed consent on his

AR/Impartial witness in case of an illiterate subject 
s entering the study should be greater than or equal to 18
d less than 80 Years of age. 3.Subjects entering the
uld be clinically and histopathologically confirmed as
d with advanced / metastatic prostate cancer. 
s participating in the study should agree to use effective
tion, in order to avoid female partner pregnancy. 
s participating in the study should have a baseline Serum
of greater than or equal to 10 ng/ml. 6.Subjects who
ergone prior radiotherapy and/or surgery can be included in
provided, the radiotherapy and/or surgery has occurred at
eeks prior to the initiation of treatment with the study
> 7.Subjects participating in the study should have
y controlled diabetes or cardiovascular disease, if suffering
page 3 / 5
PDF of Trial
 8.Subjects entering the study should have

gy Profile specifications as follows: Hemoglobin (Hb)
an 9.0 gm / dl, Platelete greater than or equal to 1, 00,000/
r/> 9.Subjects entering the study should have clinical
specifications as follows: Hepatic Profile (Bilirubin, Total
ess than or equal to 1.5 (times ULN), Alanine
nase (ALT) less than or equal to 2.5 times ULN, Aspartate
nase (AST) less than or equal to 2.5 times ULN, and Renal
(Serum Creatinine less than or equal to 1.5 times
/> 10.ECOG Performance Status of less than or equal to
1.Subjects participating in the study should have a life
cy of at least 6 months as per the investigators discretion.
Subjects who are surgically castrated will be included in the
/> 13.Potential subjects should be willing to comply with
procedures. 
Exclusion Criteria
s with any clinically significant lab test and co-morbidity
any concurrent disease that could affect the patients
per the Investigators discretion.
s with known Central Nervous System (CNS) metastasis,
clinically stable disease of at less than 8 weeks prior to the
ation of the study drug (A patient with known CNS
s and having a clinically stable disease of 8 weeks or more
cluded in the study.)
s under concurrent therapy with any other non-protocol
er therapy, including hormonal therapy or any other
anti-cancer therapy.
s under treatment for ANY Acute Urinary Tract Infection
ny other active clinically significant systemic infections.
s who are known to be hypersensitive to the study drug or
he excipients.
s who have been on the investigational drug within 30 days,
reening.
Timepoints
At Visit 4(Day90) and Visit 7 (Day180).
Timepoints
Time to At Visit 4(Day90) and Visit 7 (Day180).
from the
mented
onse as
studies
Day180).
al (PFS) At Visit 4(Day90) and Visit 7 (Day180).

atment to
page 4 / 5
PDF of Trial
At Visit 3 (Day 60), visit 5 (Day120), visit 7

(Day180) and visit 8 (Day195)
During entire study period.
During entire study period.
on-Comparative, Study to Evaluate

vanced and/or Metastatic Prostate
he reduction in circulating Prostate
ancer undergoing treatment with
ding 16 weeks of enrolment period,
ment follow-up. Total 36 patients
e study. The study will be conducted
on-Comparative, Study to Evaluate
vanced and/or Metastatic Prostate
he reduction in circulating Prostate
ancer undergoing treatment with
ding 16 weeks of enrolment period,
ment follow-up. Total 36 patients
e study. The study will be conducted
ment Phase and Treatment Phase
page 5 / 5

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Clinical Trial Details (PDF Generation Date :- Sun, 08 Jan 2023 04:50:22 GMT)

CTRI Number CTRI/2010/091/002816 [Registered on: 18/10/2010] -

Details of Principal Details of Principal Inv

Details Contact Details Contact Person (Sc

Details Contact Details Contact Person (P

Source of Monetary or Source of Monetary or Ma

Primary Sponsor Primary Sponsor D

Details of Secondary Name

Countries of List of Countries

Dr. Paramesh Bangalore Clinisearch

Dr. M M Mehndiratta G. B. Pant Hospital, #

Dr. Krishnan Vijayan Kovai Medical Center

Dr. Sandeep Kumar M.V. Hospital and

Dr. Bhawna Sharma Sawai Man Singh

Dr. Suresh Kumar Vijaya Health Centre

Details of Ethics Name of Committee Approval Status

Institutional Ethics Approved

Regulatory Clearance Status

Health Condition / Health Type

Inclusion Criteria Inclusion Crite

Exclusion Criteria Exclusion Crite

Method of Generating Computer generated randomization

To assess the efficacy of ESL as therapy in

Secondary Outcome Outcome

Weekly mean pain intensity (calculated from the

Patient and clinical global impression of change

Allodynia Visual Analog Scale (subjects rate the

Target Sample Size Total Sample Size=468

Phase of Trial Phase 3

Recruitment Status of Other (Terminated)

CTRI Number CTRI/2010/091/002925 [Registered on: 06/12/2010] -

Secondary IDs if Any Secondary ID

Details of Principal Details of Principal Inv

Details Contact Details Contact Person (Sc

Details Contact Details Contact Person (P

Source of Monetary or Source of Monetary or Ma

Primary Sponsor Primary Sponsor D

Details of Secondary Name

Dr. Arulselvan Apollo Hospitals

Dr. Neeraj Bjutani Bhutani Neuro Care

Dr. Manjunath CBI Road

Dr. Shivkumar Cerebrovascular &

Dr. Ashutosh Shetty Criticare Multispeciality

Dr. Raja Ram Agarwal Fortis Escorts Hospital

Dr. Dinesh Nayak Global Hospital & Perumbakkam,-600100

Dr. Murali K. Menon Krishna Clinic Ashwadhy, Ambika Niv

Dr. Vidya Lisie Hospital ,-682018

Dr. Bobby Varkey Lourdes Hospital ,-682012

Dr. Renu Achtani Mata Chanan Devi Janakpuri,-110070

Dr. Vivek Kumar Metrohospital & Heart X-1, Sector 12,-201301

Dr. Asad Abbas Nurocare & Research ,-226003

Dr. Sreedhar Sai Krishna Kachiguda,-500027

Dr. Veeresh Bajpai Sai Neurology Clinic ,-226022

Dr. Jitender Singh Sanjivani Hospital Near Vastrapur

Dr. Suresh Gupta Santokba Durlabji Bhavani Singh

Dr. Sangeeta Ravat Seth GSMC & KEM Parel,-400012

Dr. Ruchir Divatia Shrey Hospital

Dr. Velmurugendran Sri Ramchandra

Dr. C. H. Gopal Swetha Clinic

Dr. A.V. Srinivasan Trinity Acute Care

Dr. N. Pushpa Raju Varun Neuro Clinic

Dr. G. Satyanarayana Vijaya Healthcare

Dr. V.N. Mathur Vivekananda Hospital