NCT01688037

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess 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: 109 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

Detailed description

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for up to 2 weeks. The study will also allow for an evaluation of the efficacy of NBI-98854 50 mg once daily for up to 6 weeks and the safety and tolerability of NBI 98854 50 mg once daily for up to 12 weeks. The double-blind placebo-controlled treatment period the study has three arms: * NBI-98854 50 mg once daily for 6 weeks * NBI-98854 100 mg once daily for 2 weeks followed by 50 mg once daily for the remaining 4 weeks * placebo At the end of the 6-week placebo-controlled double-blind treatment period, subjects will continue in the study for an additional 6-week open-label period where all subjects who have completed the double-blind treatment period will receive NBI-98854 50 mg once daily. Two and four weeks after the last dose of study drug, follow-up assessments will be performed.

Conditions

• Tardive Dyskinesia

Interventions

Type	Name	Description
DRUG	NBI-98854	25 mg capsule
DRUG	NBI-98854	50 mg capsule
DRUG	Placebo

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2012-09-19
• Last updated: 2017-11-08
• Results posted: 2017-11-08

Locations

51 sites across 2 countries: United States, Puerto Rico