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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06312189
Other study ID # NBI-98854-HD3022
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04400331 - Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease Phase 3
Completed NCT04102579 - Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease Phase 3