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

NCT04102579 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2023-10-11

Study results available
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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

DRUG

Valbenazine

vesicular monoamine transporter 2 (VMAT2) inhibitor

DRUG

Placebo

non-active dosage form

Sponsors & Collaborators

  • Huntington Study Group

    collaborator NETWORK

  • Neurocrine Biosciences

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-13
Primary Completion
2021-10-15
Completion
2021-10-26
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04102579 on ClinicalTrials.gov