At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 234 enrolled
Drug / intervention
NBI-98854 +1 moredrug
Likely dose
NBI-98854 40 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.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel, Fixed-Dose Study to Assess the Efficacy, Safety, and Tolerability of NBI-98854 for the Treatment of Tardive Dyskinesia
In Brief
A Phase 3 clinical trial evaluating NBI-98854 and Placebo for Tardive Dyskinesia. Completed, enrolled 234 participants across 54 sites in 3 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTardive Dyskinesia
CountriesCanada, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
First PostedOct 2014
Primary CompletionSep 2015
Study CompletionJul 2016
TodayJul 2026
First PostedOct 24, 2014
Enrollment StartOct 1, 2014
Primary CompletionSep 1, 2015
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.7 years ago
Interventions
NBI-98854drug
NBI-98854 40 mg capsules
Placebodrug
NBI-98854 placebo capsules