Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada

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.

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Key information

Conditions

Chorea, Huntington Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Huntington Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Neurocrine Clinical Site, Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valbenazine

Drug

vesicular monoamine transporter 2 (VMAT2) inhibitor

Other names: NBI-98854

Primary outcomes

Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

Time frame: Up to Week 210

Sponsors and collaborators

Lead sponsor

Neurocrine Biosciences

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2028
First posted: Mar 15, 2024
Registry last updated: Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed