At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 37 enrolled
Drug / intervention
NBI-98854 +2 moredrug
Likely dose
NBI-98854 12.5 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, Double-Blind, Randomized, Placebo-Controlled, Two-Period Cross-Over Study to Evaluate 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 37 participants across 11 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive dyskinesia in subjects with schizophrenia or schizoaffective disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTardive Dyskinesia
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartAug 2011
Primary CompletionFeb 2012
TodayJul 2026
First PostedJul 13, 2011
Enrollment StartAug 1, 2011
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.0 years ago
Interventions
NBI-98854drug
12.5 mg powder in bottle once daily for 14 days
NBI-98854drug
50 mg powder in bottle once daily for 14 days
Placebodrug
Solution containing no active substance