NCT03698331

The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine

A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the potential for clinical dependence and withdrawal symptoms associated with valbenazine.

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: 2018-09-14
• Primary completion: 2019-04-03
• Completion: 2019-04-03
• First posted: 2018-10-09
• Last updated: 2020-06-04
• Results posted: 2020-06-04

Locations

17 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study