Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada
- Registration Number
- NCT06312189
- Lead Sponsor
- Neurocrine Biosciences
- Brief Summary
This study will evaluate long-term safety and tolerability of valbenazine in participants with chorea associated with Huntington Disease (HD) who participated in Study NBI-98854-HD3006 (NCT04400331) in Canada.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
- Participated in Study NBI-98854-HD3006 and completing dosing through the Week 156 visit; or were actively participating, receiving study treatment, and completed an early termination visit Study NBI-98854-HD3006 at the time of the study closure at sites in Canada.
- Participants of childbearing potential must agree to use contraception consistently while participating in the study until 30 days after last dose of the study treatment.
Key
Exclusion Criteria
- Have difficulty swallowing
- Are currently pregnant or breastfeeding
- Have a medically significant abnormality, physical examination finding, clinically significant laboratory abnormality
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Valbenazine Valbenazine Capsule, administered orally once daily.
- Primary Outcome Measures
Name Time Method Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Up to Week 106
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Neurocrine Clinical Site
🇨🇦Toronto, Ontario, Canada