At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 102 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, Dose-Titration Study to Assess the Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Tardive Dyskinesia
In Brief
A Phase 2 clinical trial evaluating NBI-98854 and Placebo for Tardive Dyskinesia. Completed, enrolled 102 participants across 22 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 (titrated to a subject's optimal dose in the range of 25 to 75 mg) 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
First PostedNov 2012
Enrollment StartDec 2012
Primary CompletionDec 2013
TodayJul 2026
First PostedNov 26, 2012
Enrollment StartDec 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.6 years ago
Interventions
NBI-98854drug
25 mg capsule
NBI-98854drug
50 mg capsule
Placebodrug