Clinical Trial: First Time Use of SD-809 in Huntington Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized Double Blind, Placebo Controlled Study of SD-809 Extended Release for the Treatment of Chorea Associated With Huntington Disease
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: Teva Pharmaceutical Industries
Current Primary Outcome: Total Maximal Chorea Score (TMC) [ Time Frame: 12 weeks ]
Original Primary Outcome: Total Maximal Chorea Score (TMC) [ Time Frame: 3 weeks ]
Current Secondary Outcome:
- Treatment Success at the end of therapy as measured by the Patient Global Impression of Change (PGIC) [ Time Frame: 12 weeks ]
- Treatment success at the end of therapy based on Clinical Global Impression of Change (CGIC) [ Time Frame: 12 weeks ]
- Change in Short Form 36 Health Survey (SF-36) Physical component summary score [ Time Frame: 12 weeks ]
- Change in Berg Balance Test (BBT) [ Time Frame: 12 weeks ]
Original Secondary Outcome: Same as current
Information By: Teva Pharmaceutical Industries
Dates:
Date Received: February 20, 2013
Date Started: July 2013
Date Completion:
Last Updated: January 12, 2016
Last Verified: January 2016
