NCT02405091

Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tardive Dyskinesia

Interventions

Type	Name	Description
DRUG	NBI-98854

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2015-04-01
• Last updated: 2018-11-30
• Results posted: 2018-11-30

Locations

48 sites across 3 countries: United States, Canada, Puerto Rico