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

Chorea, Huntington Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06312189
• Other study ID #: NBI-98854-HD3022
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: April 24, 2024
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 7
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chorea
• Chorea, Huntington
• Huntington Disease

Intervention

Drug:
• Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor

Locations

Country	Name	City	State
Canada	Neurocrine Clinical Site	Ottawa	Ontario
Canada	Neurocrine Clinical Site	Toronto	Ontario
Canada	Neurocrine Clinical Site	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Treatment-Emergent Adverse Events (TEAEs)		Up to Week 106