Clinical trial

Open-Label Study of Valbenazine for the Treatment of Chorea Associated With Huntington Disease in Canada

Name
NBI-98854-HD3022
Description
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.
Trial arms
Trial start
2024-03-01
Estimated PCD
2026-03-01
Trial end
2026-03-01
Phase
Early phase I
Treatment
Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Arms:
Valbenazine
Other names:
NBI-98854
Size
7
Primary endpoint
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Up to Week 106
Eligibility criteria
Key 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 7, 'type': 'ESTIMATED'}}
Updated at
2024-03-15

1 organization

1 product

2 indications

Indication
Chorea