CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 119 enrolled
Drug / intervention
SD-809drug
Likely dose
SD-809 12 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01897896
NCT01897896Phase 3Completed
CompareCT.gov

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

Auspex Pharmaceuticals, Inc.·interventional·Posted Jul 12, 2013·Updated Nov 9, 2021

In Brief

A Phase 3 clinical trial evaluating SD-809 for Chorea Associated With Huntington Disease. Completed, enrolled 119 participants across 38 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChorea Associated With Huntington Disease
CountriesAustralia, Canada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 12, 2013
Enrollment StartNov 12, 2013
Primary CompletionAug 21, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 13.0 years ago

Interventions

SD-809drug

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