Patient

Study Guide
This Study Guide contains
important information about
the OAK Study. Please keep it
in a safe place.
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Thank you
Thank you for continuing to participate in this important clinical
research program. The OAK Study is the third of 3 ampreloxetine
(also known as TD-9855) studies for people with symptomatic
neurogenic orthostatic hypotension. The 3 studies in this series are
the SEQUOIA Study, the REDWOOD Study, and the OAK Study. You
were invited to take part in the OAK Study because you previously
completed the REDWOOD Study
This Study Guide describes what you can expect during each visit
which can be conducted either at the study center or at your home
and what you need to do during this study. You can share it with
your caregiver, if applicable.

If you have any questions, please ask a member

of the study team. Contact details can be found
on the back cover of this Study Guide.

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What will happen during the OAK Study?
The OAK Study will gather information about the long-term
safety of the same investigational drug you received during the
REDWOOD Study. All participants in the OAK Study will take the
investigational drug once daily for up to 182 weeks (3½ years).

Transitioning from the REDWOOD Study

Visit 1 of the OAK Study will occur on the
same day as Visit 9 of the REDWOOD Study.
This will be considered “Day 1” of the OAK
Study. You will be given a new supply of the
investigational drug at this visit and will start
taking it the following morning.

Treatment period
You will take the investigational
drug once daily for up to 182
weeks. During this period, you will
have 14 more visits either at the
study center or at your home and 7
telephone calls.

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 Follow-up telephone call
About 2 weeks after you stop taking
the investigational drug, you will
have 1 final telephone call to check
your health.

If you wish to leave the study before it is over, please tell the study
doctor. You will be asked to complete an early termination visit
(if you leave the study before Week 26) or an end of treatment visit
(if you leave the study after Week 26) either at the study center or at
your home. You will need to return any unused investigational drug,
empty bottles, and your study diaries. You will also have a follow-up
telephone call 2 weeks after you stop taking the investigational drug.

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What will happen at your study visits?
Treatment

Visit Visit Visit Visit Phone Visit

Visit number
1 2 3 4 call 5

When will this happen?

Week Week Week Week Week Week
0 2 6 10 14 18

Review and sign the Informed


Consent Form

Check that this study is right for you 

Medical history 

Vital signs     

Physical and neurological exams  

Electrocardiogram (ECG)  

Pregnancy test (only for women

 
who can get pregnant)

Blood and urine tests  

Questions about how you are feeling and

     
any other medications you have taken

Questionnaires     

EoT = End of Treatment

*You will either have this visit at Week 182, or sooner if you leave the study early
(after Week 26 but before Week 182).
All participants will have this follow-up call. It will be 2 weeks after your last dose,
†

even if you leave the study early.

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 EoT Early termination
period
visit* visit
Follow-up
(if you leave the
phone call†
Phone Visit Visit Visits Phone Visit Visit study before
call 6 7 8–12 call 13 14 Week 26)

Weeks Weeks
Week Week Week 50, 74, 62, 86, Week Week Week
22 26 38 98, 122, 110, 134, 170 182 184
146 158

 

 

 

   

 

        

 

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What are my responsibilities during the study?
There are some important things to remember while taking part
in the OAK Study.

DO

 Follow all instructions given to you by the study team

 Take the investigational drug at about the same time every
morning with about a cup (250 mL or 8 oz) of water
 Complete your Dosing Diary and Incidence of Falls Diary
every day (for the first 26 weeks of the study only)
o Also complete your Midodrine Medication Diary as
needed (if you are prescribed midodrine). Information
about midodrine and the Midodrine Medication Diary
is provided on page 10 of this guide
 Tell the study doctor immediately about any side effects
or changes in your health, whether or not you think they
are related to the investigational drug
 Remember to drink plenty of water during your study visits

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DO NOT

O Do not make any significant changes to your diet during

this study
O Do not take any medications that are not allowed during
this study
o Tell the study doctor about all medications you are
currently taking and any changes to these medications
O Do not get pregnant or father a child during this study
O Use a highly effective form of birth control during the
study and for at least 30 days after the last dose of
investigational drug

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If you are prescribed midodrine
During this study, you may also be given midodrine during the
first 26 weeks (it is up to the study doctor) to help manage your
symptoms. The following information is important if you are given
midodrine:
• The study doctor will tell you how much midodrine to take
(no more than 10 mg on 1 day in any given week)
• For the first 26 weeks of the study, record the following
information in your Midodrine Medication Diary every time
you take this medication:
o Date and day of the week
o How much midodrine you took
o Any comments you might have (e.g. reason for taking
midodrine)
• Do not take midodrine on days when you have study visits
• The last daily dose of midodrine should be taken at least
4 hours before bedtime
• As with any medicine, you may experience side effects. Your
study doctor can provide further information relating to these
side effects, but the most common side effects of midodrine are:

o Lying and sitting o Heartburn

hypertension o Nausea
o Paresthesia o Inflammation
(pins and needles) of the mouth and lips
o Itching (mainly of the scalp) o The urge to urinate
o Goosebumps o Urine retention
o Chills o A change in urinary
o Skin rash and redness frequency

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NOTES

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Important reminder
Please bring to the study center or have available at home the
following for each study visit:
• Your study booklet with completed diaries (for the first
26 weeks only)
• All unused investigational drug and empty bottles

Contact information

Please contact a member of the study team as soon as possible

if you:
• Are thinking about leaving the study
• Notice any changes in your health
• Cannot attend a study visit and need to reschedule
• Have any questions during the study

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© 2019 Theravance Biopharma. All rights reserved. Patient Study Guide, 1 Sept 2020 [V03 USA(en)]