NCT01795859

First Time Use of SD-809 in Huntington Disease

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of SD-809 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 and 45 subjects receiving placebo. The study will be conducted at approximately 30 centers in the U.S. and Canada.

Conditions

• Chorea

Interventions

Type	Name	Description
DRUG	SD-809	SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
DRUG	Placebo	Placebo tablets are identical in appearance to SD-809 tablets.

Timeline

• Start date: 2013-08-05
• Primary completion: 2014-12-05
• Completion: 2014-12-05
• First posted: 2013-02-21
• Last updated: 2017-09-20
• Results posted: 2017-08-11

Locations

43 sites across 3 countries: United States, Australia, Canada