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
Organization
Neurocrine BiosciencesProduct
ValbenazineIndication
ChoreaIndication
Huntington's disease