CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 298 enrolled / 298 target
Drug / intervention
SD-809 +1 moredrug
Likely dose
6 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/NCT02291861
NCT02291861Phase 3CompletedMonitor (2.1/mo)Completion was 118mo ago
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia

Auspex Pharmaceuticals, Inc.·interventional·Posted Nov 17, 2014·Updated Jun 23, 2026

In Brief

A Phase 3 clinical trial evaluating SD-809 and Placebo for Tardive Dyskinesia. Completed, enrolled 298 participants across 106 sites in 6 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

The purpose of this study is to determine whether fixed-doses of an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.

Study Details

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

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 17, 2014
Enrollment StartOct 31, 2014
Primary CompletionAug 19, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.6 years ago

Arms & Interventions

Placeboplacebo_comparator

Placebo tablets taken twice daily for 12 weeks.

Drug: Placebo
SD-809 12 mg/dayexperimental

SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.

Drug: SD-809
SD-809 24 mg/dayexperimental

SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.

Drug: SD-809
SD-809 36 mg/dayexperimental

SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.

Drug: SD-809

Interventions

SD-809drug

SD-809 tablets dose titrated for 4 weeks until target randomized dose is reached. The dose is maintained for an additional 8 weeks. Tablets were swallowed whole with water and taken with food.

Placebodrug

Placebo tablets taken twice daily for 12 weeks. Tablets were swallowed whole with water and taken with food.