First Time Use of SD-809 in Huntington Disease



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:2/7/2015
Start Date:June 2013
End Date:August 2015
Contact:Huntington Study Group (HSG)
Email:info@hsglimited.org
Phone:800-487-7671

Use our guide to learn which trials are right for you!

A Randomized Double Blind, Placebo Controlled Study of SD-809 Extended Release for the Treatment of Chorea Associated With Huntington Disease

The purpose of this study is to determine whether SD-809 ER tablets are effective in the
treatment of chorea associated with Huntington's Disease.

This is a randomized, double blind, placebo controlled, parallel group study designed to
evaluate the efficacy, safety and tolerability of SD-809 ER for the treatment of chorea
associated with Huntington's Disease. Approximately 90 subjects will be randomized (1:1)
into the study, with approximately 45 subjects receiving SD-809 ER and 45 subjects receiving
placebo. The study will be conducted at approximately 30 centers in the U.S. and Canada.

Inclusion Criteria:

1. Subject is at least 18 years of age or the age of majority (whichever is older) at
Screening.

2. Subject has been diagnosed with manifest HD, as indicated by characteristic motor
exam features and has a documented expanded CAG repeat (≥ 37) at or before Screening.

3. Subject has a Total Maximal Chorea Score (TMC) ≥ 8 at Screening and Baseline.

4. Subject has a Total Functional Capacity (TFC) score ≥ 5 at Screening.

5. Subject is able to swallow study medication whole.

6. Subject has provided written, informed consent or, a legally authorized
representative (LAR) has provided written informed consent and the subject has
provided assent.

7. Female subjects of childbearing potential agree to use an acceptable method of
contraception from screening through study completion.

8. The subject has a reliable caregiver who interacts with the patient on a daily basis,
oversees study drug administration, assures attendance at study visits and
participates in evaluations, as required.

9. Subject is able to ambulate without assistance for at least 20 yards (Note: The use
of assistive devices (i.e., walker, cane) is permitted during ambulation).

Exclusion Criteria:

1. Subject has a serious untreated or under-treated psychiatric illness, such as
depression, at Screening or Baseline.

2. Subject has active suicidal ideation at Screening or Baseline.

3. Subject has history of suicidal behavior at Screening or Baseline:

4. Subject has evidence for depression at Screening or Baseline.

5. Subject has an unstable or serious medical or psychiatric illness at Screening or
Baseline.

6. Subject has been recently exposed to tetrabenazine.

7. Subject has received any of the following concomitant medications within 30 days of
Screening or Baseline:

- Antipsychotics

- Metoclopramide

- Monoamine oxidase inhibitors (MAOI)

- Levodopa or dopamine agonists

- Reserpine

- Amantadine

- Memantine

8. Subject has significantly impaired swallowing function at Screening.

9. Subject has significantly impaired speaking at Screening.

10. Subject requires treatment with drugs known to prolong the QT interval.

11. Subject has a prolonged QT interval on 12-lead ECG at Screening.

12. Subject has evidence of hepatic impairment at Screening.

13. Subject has evidence of significant renal impairment at Screening.

14. Subject has known allergy to any of the components of study medication.

15. Subject has participated in an investigational drug or device trial within 30 days
(or 5 drug half-lives) of Screening, whichever is longer.

16. Subject is pregnant or breast-feeding at Screening or Baseline.

17. Subject acknowledges present use of illicit drugs at Screening.

18. Subject has a history of alcohol or substance abuse in the previous 12 months.
We found this trial at
34
sites
?
mi
from
Albany, NY
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Burlington, VT
Click here to add this to my saved trials
?
mi
from
Camden, NJ
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
Englewood, CO
Click here to add this to my saved trials
?
mi
from
Fayetteville, AR
Click here to add this to my saved trials
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
?
mi
from
Kirkland, WA
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Brunswick, New Jersey 08901
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Patchogue, NY
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials