CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 161 enrolled
Drug / intervention
Valbenazinedrug
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/NCT02736955
NCT02736955Phase 3Completed

Open-Label Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia

Neurocrine Biosciences·interventional·Posted Apr 13, 2016·Updated Dec 19, 2018

In Brief

A Phase 3 clinical trial evaluating Valbenazine for Tardive Dyskinesia. Completed, enrolled 161 participants across 27 sites.

Detailed Summary

This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for the treatment of adults with TD until valbenazine is anticipated to be available commercially or they complete 72 weeks of treatment. This study will allow enrollment of up to 150 medically stable male and female participants with TD who previously participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 13, 2016
Enrollment StartJun 13, 2016
Primary CompletionJun 30, 2017
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 10.2 years ago

Interventions

Valbenazinedrug