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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. ;


Study Design


Related Conditions & MeSH terms


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

See also
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