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

Neurocrine Biosciences

Status and phase: Invitation-only; Phase 3

Conditions: Chorea, Huntington

Treatments: Drug: Valbenazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06312189

NBI-98854-HD3022

Details and patient eligibility

About

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.

Enrollment: 7 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Valbenazine

Experimental group

Description:

Capsule, administered orally once daily.

Treatment:

Drug: Valbenazine