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Greater Occipital Nerve Block for Migraine Prophylaxis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study
does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00915473

Recruitment Status  : Completed

First Posted  : June 8, 2009
Results First Posted  : February 25, 2014
Last Update Posted  : March 20, 2014

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Sponsor:
Mayo Clinic

Collaborator:
National Center for Advancing Translational Science (NCATS)

Information provided by:

Mayo Clinic

Study Details Tabular View Study Results Disclaimer How to Read a Study Record

Study Description Go to

Brief Summary:

Migraine is a common neurological condition that can be disabling, particularly if chronic. Greater occipital nerve (GON) block has been
utilized for decades for the treatment of migraine in the absence of a single randomized, placebo-controlled trial documenting its
effectiveness.

Hypothesis: Greater occipital nerve block reduces the frequency of days with moderate or severe headache in patients with episodic or
chronic migraine.

Condition or disease  Intervention/treatment  Phase 

Migraine Headache Drug: bupivicaine Phase 4

Drug: normal saline

Drug: methylprednisolone

Drug: lidocaine

Detailed Description:

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Migraine is a common disease with lifetime prevalence in women and men of 33% and 12% respectively. Chronic migraine affects 2% of the
US population and is highly disabling. There are no FDA approved medications for the treatment of chronic migraine.

Although some patients benefit from a daily prophylactic medication, others continue to suffer from severe, frequent, debilitating headaches.
Limited efficacy, poor compliance, side effects and drug-drug interactions may explain why more than 80% of migraineurs in the population
are not prescribed daily prophylactic medications.

Occipital nerve injections with corticosteroids and/or local anesthetics have been employed for the acute and prophylactic treatment of
migraine, cervicogenic headache and cluster headache for decades. A long-acting anesthetic and corticosteroid are often combined,
although anesthetic agents have also been used alone. However, there are no randomized controlled trials evaluating the preventive efficacy
of occipital nerve block in subjects with migraine.

Patients were equally randomized to receive either 2.5 ml 0.5% bupivacaine plus 0.5 ml 20 mg methylprednisolone over the ipsilateral
(unilateral headache) or bilateral (bilateral headache) occipital nerve or 2.75 ml normal saline plus 0.25 ml 1% lidocaine without epinephrine
(placebo). The GON injection site was at the medial third of the distance between the occipital protuberance and the mastoid process.
Patients were evaluated after the 4-week baseline diary completion phase to undergo the injection, and for 4 weeks after the injection.
Therefore, there were 3 patient visits in this study: screening, injection and 4-week follow-up. In an effort to ensure adequate blinding, 0.25
ml of short-acting 1% lidocaine without epinephrine was used as the placebo arm. In order to ensure adequate blinding of the investigator,
each syringe and needle hub was covered with opaque tape so as to ensure blinding of the investigator providing the injection. A total of four
investigators provided injections. The blinded investigator who evaluated the study subject 4 weeks after injection may or may not be the
same as the investigator who provided the injection.

Study Design Go to

Study Type  : Interventional (Clinical Trial)

Actual Enrollment  : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Greater Occipital Nerve Block for Migraine Prophylaxis
Study Start Date  : June 2009
Actual Primary Completion Date  : January 2013

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Actual Study Completion Date  : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Arms and Interventions Go to

Arm  Intervention/treatment 

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Arm  Intervention/treatment 

Experimental: Active Injection Drug: bupivicaine

Subjects randomized to this arm will receive 2.5 mL 0.5% 2.5 mL 0.5% bupivicaine
bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over Other Names:
the ipsilateral (unilateral headache) or bilateral (bilateral
Marcain
headache) occipital nerve.
Marcaine
Sensorcaine
Vivacaine

Drug: methylprednisolone
0.5 mL 20 mg methylprednisolone
Other Names:
Medrol
Solu-Medrol

Placebo Comparator: Placebo Injection Drug: normal saline

Subjects randomized to this arm will receive 2.75 mL normal 2.75 mL normal saline
saline plus 0.25 mL 1% lidocaine injected over the ipsilateral
(unilateral headache) or bilateral (bilateral headache) occipital Drug: lidocaine
nerve. 0.25 mL 1% lidocaine
Other Name: xylocaine

Outcome Measures Go to

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Primary Outcome Measures  :

1. Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post
Injection Compared to the 4 Week Pre-injection Baseline Period [ Time Frame: 4 weeks pre-injection baseline, 4 weeks post-injection ]

The baseline frequency will be the number of calendar days with moderate or severe migraine during the 4 week period prior to
injection, and the follow-up frequency will be the number of calendar days with migraine during the 4 week period following injection.

Secondary Outcome Measures  :

1. Mean Frequency of Days With a Migraine [ Time Frame: 4 weeks post-injection ]

2. Mean Number of Hours With Moderate or Severe Migraine [ Time Frame: 4 weeks post-injection ]
3. Mean Number of Days With Acute Medication Use [ Time Frame: 4 weeks post-injection ]

Acute medication use meant "the consumption of a drug to abort or terminate a headache."

Eligibility Criteria Go to

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members
or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the
study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)

Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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Criteria

Inclusion Criteria:

Subjects meet diagnostic criteria for episodic migraine or chronic migraine according to the International Headache Classification II
(ICHD-II)
Migraine sufferers who experience at least 1 attack per week
Able to read and understand the requirements of the study, abide by any restrictions, and return for the required examinations

Able and willing to sign an informed consent statement

Subjects must be in generally good health as confirmed by medical history, medication review, baseline physical examination, vital signs
and clinical laboratory evaluations.

Exclusion Criteria:

Subjects with continuous headache (no headache free periods)

Subjects using maintenance opioid medication
Subjects who have started a medication with prophylactic migraine efficacy within the past 2 months
Known hypersensitivity or allergic reaction to any of study ingredients (lidocaine, bupivicaine, any local anesthetics, and corticosteroids)
or betadine.

Use of any investigational medication within 90 days of the initial screening visit and/or concurrent enrolment in an investigational study
Injection site infection or systemic infection at the injection visit (afebrile at time of injection)
Presence of cranial bone defect

Subjects with chronic cluster headache, new daily persistent headache, hemicrania continua, or chronic tension type headache
Subjects with a history of an unstable medical condition (e.g. cardiovascular, hepatic, renal, endocrine) that may impair their reliable
participation in the study or necessitate the use of medications not permitted in this study
Subjects with a history (within the past 6 months) of a major psychiatric disorder that in the opinion of the investigator may preclude the
subject from completed the requirements of the study
Female subjects who are pregnant or nursing

Subjects with a history of drug or alcohol abuse within the past 2 years
Subjects with a history of poor compliance with past drug therapies, as judged by the investigator.
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Contacts and Locations Go to

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact
information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915473

Locations

United States, Arizona

Mayo Clinic
Phoenix, Arizona, United States, 85054

Sponsors and Collaborators

Mayo Clinic

National Center for Advancing Translational Science (NCATS)

Investigators

Principal Investigator: David W. Dodick, M.D. Mayo Clinic

More Information Go to

Additional Information:

Mayo Clinic Clinical Trials

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dilli E, Halker R, Vargas B, Hentz J, Radam T, Rogers R, Dodick D. Occipital nerve block for the short-term preventive treatment of
migraine: A randomized, double-blinded, placebo-controlled study. Cephalalgia. 2015 Oct;35(11):959-68. doi: 10.1177/0333102414561872.
Epub 2014 Dec 12.

Responsible Party: David W. Dodick M.D., Mayo Clinic

ClinicalTrials.gov Identifier: NCT00915473 History of Changes
Other Study ID Numbers: 08-008203
UL1TR000135 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2009 Key Record Dates
Results First Posted: February 25, 2014
Last Update Posted: March 20, 2014
Last Verified: February 2014

Additional relevant MeSH terms:

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3/1/2021 Greater Occipital Nerve Block for Migraine Prophylaxis - Full Text View - ClinicalTrials.gov

Migraine Disorders Bupivacaine

Headache Prednisolone hemisuccinate
Headache Disorders, Primary Prednisolone phosphate
Headache Disorders Anesthetics, Local
Brain Diseases Anesthetics
Central Nervous System Diseases Central Nervous System Depressants
Nervous System Diseases Physiological Effects of Drugs
Pain Sensory System Agents
Neurologic Manifestations Peripheral Nervous System Agents
Methylprednisolone Anti-Arrhythmia Agents
Methylprednisolone Acetate Voltage-Gated Sodium Channel Blockers
Methylprednisolone Hemisuccinate Sodium Channel Blockers
Prednisolone Membrane Transport Modulators
Prednisolone acetate Molecular Mechanisms of Pharmacological Action
Lidocaine Anti-Inflammatory Agents

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