NCT04102579

Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of valbenazine to treat chorea in participants with Huntington disease.

Conditions

• Chorea, Huntington

Interventions

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

Timeline

• Start date: 2019-11-13
• Primary completion: 2021-10-15
• Completion: 2021-10-26
• First posted: 2019-09-25
• Last updated: 2023-10-11
• Results posted: 2023-10-11

Locations

46 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study