Trials / Active Not Recruiting
Active Not RecruitingNCT04400331
Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 154 (actual)
- Sponsor
- Neurocrine Biosciences · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
After completion of Week 156/early termination visit, participants in the US will be given the option to continue into an extended maintenance period for up to 104 weeks and participants in Canada will have the option to participate in a separate open-label study (Study NBI-98854-HD3022).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Valbenazine | vesicular monoamine transporter 2 (VMAT2) inhibitor |
Timeline
- Start date
- 2020-09-18
- Primary completion
- 2026-03-01
- Completion
- 2026-03-01
- First posted
- 2020-05-22
- Last updated
- 2024-12-24
Locations
34 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04400331. Inclusion in this directory is not an endorsement.