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

Tardive Dyskinesia Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dyskinesias
• Psychotic Disorders
• Schizophrenia
• Tardive Dyskinesia

• NCT number: NCT01688037
• Study type: Interventional
• Source: Neurocrine Biosciences
• Status: Completed
• Phase: Phase 2
• Start date: September 2012
• Completion date: October 2013