Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease
NCT04400331 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 154
Last updated 2024-12-24
Summary
This is a Phase 3, open-label study to evaluate the long-term safety and tolerability of valbenazine, and to provide participants continued access to valbenazine for the treatment of chorea associated with Huntington disease.
Conditions
- Chorea, Huntington
Interventions
- DRUG
-
Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Sponsors & Collaborators
-
Huntington Study Group
collaborator NETWORK -
Neurocrine Biosciences
lead INDUSTRY
Principal Investigators
-
Chief Medical Officer · Chief Medical Officer
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-18
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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