NCT03891862

Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia

A Phase 4, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the persistence of effect of valbenazine 40 mg and 80 mg.

Conditions

• Tardive Dyskinesia (TD)

Interventions

Type	Name	Description
DRUG	Valbenazine	vesicular monoamine transporter 2 (VMAT2) inhibitor
DRUG	Placebo oral capsule	non-active dosage form

Timeline

• Start date: 2019-03-18
• Primary completion: 2019-12-23
• Completion: 2020-01-30
• First posted: 2019-03-27
• Last updated: 2021-04-20
• Results posted: 2021-03-10

Locations

43 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study