CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 167 enrolled
Drug / intervention
NBI-98854drug
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.

Search/NCT02405091
NCT02405091Phase 3Completed
CompareCT.gov

A Phase 3, Open-Label, Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia

Neurocrine Biosciences·interventional·Posted Apr 1, 2015·Updated Nov 30, 2018

In Brief

A Phase 3 clinical trial evaluating NBI-98854 for Tardive Dyskinesia. Completed, enrolled 167 participants across 48 sites in 3 countries.

Detailed Summary

Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately 150 medically stable male and female subjects with clinical diagnoses of schizophrenia or schizoaffective disorder with neuroleptic-induced TD or mood disorder with neuroleptic-induced TD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTardive Dyskinesia
CountriesCanada, Puerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 1, 2015
Enrollment StartMar 1, 2015
Primary CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 11.3 years ago

Interventions

NBI-98854drug