NCT02274558

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 234 (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 NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

Detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel, fixed-dose study to evaluate the efficacy, safety, and tolerability of two doses of NBI-98854 (40 mg and 80 mg) compared to placebo, administered once daily. The study design includes a double-blind, placebo-controlled treatment period for 6 weeks and a double-blind NBI-98854 treatment period for an additional 42 weeks, for a total of 48 weeks of treatment. Final follow-up assessments will be conducted 4 weeks after the last dose of the study drug.

Conditions

• Tardive Dyskinesia

Interventions

Type	Name	Description
DRUG	NBI-98854	NBI-98854 40 mg capsules
DRUG	Placebo	NBI-98854 placebo capsules

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-09-01
• Completion: 2016-07-01
• First posted: 2014-10-24
• Last updated: 2017-07-11
• Results posted: 2017-07-11

Locations

54 sites across 3 countries: United States, Canada, Puerto Rico