First Time Use of SD-809 in Huntington Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Chorea

In brief

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

Key facts

Study ID

NCT01795859

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

90

Starts

2013-08-05

Expected to finish

2014-12-05

Last updated by the study team

2017-09-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is at least 18 years of age or the age of majority (whichever is older) at Screening.
• Subject has been diagnosed with manifest HD
• Subject is able to swallow study medication whole.
• Female subjects of childbearing potential agree to use an acceptable method of contraception from screening through study completion.
• 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.
• 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).

You may not qualify if…

• Subject has a serious untreated or under-treated psychiatric illness, such as depression, at Screening or Baseline.
• Subject has active suicidal ideation at Screening or Baseline.
• Subject has history of suicidal behavior at Screening or Baseline:
• Subject has evidence for depression at Screening or Baseline.
• Subject has an unstable or serious medical or psychiatric illness at Screening or Baseline.
• Subject has been recently exposed to tetrabenazine.
• 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
• Subject has significantly impaired swallowing function at Screening.
• Subject has significantly impaired speaking at Screening.
• Subject requires treatment with drugs known to prolong the QT interval.
• Subject has a prolonged QT interval on 12-lead ECG at Screening.
• Subject has evidence of hepatic impairment at Screening.
• Subject has evidence of significant renal impairment at Screening.
• Subject has known allergy to any of the components of study medication.
• Subject has participated in an investigational drug or device trial within 30 days (or 5 drug half-lives) of Screening, whichever is longer.
• Subject is pregnant or breast-feeding at Screening or Baseline.
• Subject acknowledges present use of illicit drugs at Screening.
• Subject has a history of alcohol or substance abuse in the previous 12 months.

Where it is running

• Teva Investigational Site 057 — Birmingham, Alabama, United States
• Teva Investigational Site 038 — Phoenix, Arizona, United States
• Teva Investigational Site 298 — Fayetteville, Arkansas, United States
• Teva Investigational Site 050 — Los Angeles, California, United States
• Teva Investigational Site 052 — Englewood, Colorado, United States
• Teva Investigational Site 333 — Washington D.C., District of Columbia, United States
• Teva Investigational Site 196 — Boca Raton, Florida, United States
• Teva Investigational Site 160 — Gainesville, Florida, United States
• Teva Investigational Site 014 — Miami, Florida, United States
• Teva Investigational Site 032 — Atlanta, Georgia, United States
• Teva Investigational Site 045 — Indianapolis, Indiana, United States
• Teva Investigational Site 024 — Iowa City, Iowa, United States
• Teva Investigational Site 029 — Kansas City, Kansas, United States
• Teva Investigational Site 083 — Wichita, Kansas, United States
• Teva Investigational Site 087 — Louisville, Kentucky, United States
• Teva Investigational Site 028 — Baltimore, Maryland, United States
• Teva Investigational Site 040 — Boston, Massachusetts, United States
• Teva Investigational Site 027 — St Louis, Missouri, United States
• Teva Investigational Site 194 — Las Vegas, Nevada, United States
• Teva Investigational Site 328 — Camden, New Jersey, United States
• Teva Investigational Site 026 — New Brunswick, New Jersey, United States
• Teva Investigational Site 037 — Albany, New York, United States
• Teva Investigational Site 002 — New York, New York, United States
• Teva Investigational Site 342 — Patchogue, New York, United States
• Teva Investigational Site 119 — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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