CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 343 enrolled
Drug / intervention
SD-809 +1 moredrug
Likely dose
Not stated in 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/NCT02198794
NCT02198794Phase 3Completed
CompareCT.gov

An Open-Label, Long-Term Safety Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia

Auspex Pharmaceuticals, Inc.·interventional·Posted Jul 24, 2014·Updated Apr 1, 2022

In Brief

A Phase 3 clinical trial evaluating SD-809 and Placebo for Tardive Dyskinesia. Completed, enrolled 343 participants across 82 sites in 6 countries.

Detailed Summary

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe tardive dyskinesia. The purpose of part B is to establish the durability of effect of SD-809 following 1-week period of randomized withdrawal (SD-809 and placebo), followed by 12 weeks of maintenance with SD-809.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTardive Dyskinesia
CountriesCzechia, Germany, Hungary, Poland, Slovakia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 24, 2014
Enrollment StartOct 20, 2014
Primary CompletionDec 6, 2019
Study CompletionDec 14, 2020
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 11.9 years ago

Interventions

SD-809drug

SD-809 will be administered per dose and schedule specified in the arm.

Placebodrug

Placebo matching to SD-809 will be administered per schedule specified in the arm.