At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 117 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.
A Randomized, Double-Blind, Placebo-Controlled Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia
In Brief
A Phase 3 clinical trial evaluating SD-809 and Placebo for Tardive Dyskinesia. Completed, enrolled 117 participants across 41 sites in 4 countries.
Detailed Summary
The purpose of this study is to determine whether 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, Poland, Slovakia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJun 2014
First PostedJul 2014
Primary CompletionMay 2015
TodayJul 2026
First PostedJul 21, 2014
Enrollment StartJun 1, 2014
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.9 years ago
Interventions
SD-809drug
SD-809 tablets taken twice daily for 12 weeks, includes a dose titration period and maintenance period.
Placebodrug
Placebo tablets taken twice daily for 12 weeks.