First Time Use of SD-809 in Huntington Disease

• Status: Completed
• Trial end date: 2014-12-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.