At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 109 enrolled
Drug / intervention
NBI-98854 +2 moredrug
Likely dose
NBI-98854 25 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 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
In Brief
A Phase 2 clinical trial evaluating NBI-98854 and Placebo for Tardive Dyskinesia. Completed, enrolled 109 participants across 51 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTardive Dyskinesia
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2012
First PostedSep 2012
Primary CompletionSep 2013
Study CompletionOct 2013
TodayJul 2026
First PostedSep 19, 2012
Enrollment StartSep 1, 2012
Primary CompletionSep 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.8 years ago
Interventions
NBI-98854drug
25 mg capsule
NBI-98854drug
50 mg capsule
Placebodrug