NCT01897896

Alternatives for Reducing Chorea in Huntington Disease

An Open-Label, Long Term Safety Study of SD-809 ER in Subjects With Chorea Associated With Huntington Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Auspex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of SD-809 extended release (ER) in participants switching from tetrabenazine to SD-809 ER. In addition, the safety and tolerability of long-term treatment with SD-809 ER will be assessed in "Switch" participants as well as "Rollover" participants completing a randomized, double blind, placebo-controlled study of SD-809 ER.

Conditions

• Chorea Associated With Huntington Disease

Interventions

Type	Name	Description
DRUG	SD-809	SD-809 tablets will be provided in dose strengths of 6, 9 and 12 mg.

Timeline

• Start date: 2013-11-12
• Primary completion: 2017-08-21
• Completion: 2017-08-21
• First posted: 2013-07-12
• Last updated: 2021-11-09
• Results posted: 2019-04-16

Locations

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

Regulatory

• FDA-regulated drug study