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A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia (KINECT 3)

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Last updated:1st Oct 2014

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


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel, Fixed-Dose Study to Assess the Efficacy, Safety, and Tolerability of NBI-98854 for the Treatment of Tardive Dyskinesia
Estimated Enrollment: 240
Study Start Date: October 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
NBI-98854 40 mg
- Experimental: NBI-98854 80 mg
- Experimental: Placebo

Category Value
Study start date 2014-10-01

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