NCT01393600

NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tardive Dyskinesia

Interventions

Type	Name	Description
DRUG	NBI-98854	12.5 mg powder in bottle once daily for 14 days
DRUG	NBI-98854	50 mg powder in bottle once daily for 14 days
DRUG	Placebo	Solution containing no active substance

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2011-07-13
• Last updated: 2017-08-10
• Results posted: 2017-08-10

Locations

11 sites across 1 country: United States