NCT02736955

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study was terminated after 60 weeks due to the commercial availability of valbenazine.

Conditions

• Tardive Dyskinesia

Interventions

Type	Name	Description
DRUG	Valbenazine

Timeline

• Start date: 2016-06-13
• Primary completion: 2017-06-30
• Completion: 2017-06-30
• First posted: 2016-04-13
• Last updated: 2018-12-19
• Results posted: 2018-12-19

Locations

27 sites across 1 country: United States