NCT06312189

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

3 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 24, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

March 8, 2024

Last Update Submit

April 6, 2026

Conditions

Chorea, Huntington

Outcome Measures

Primary Outcomes (1)

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

    Up to Week 106

Study Arms (1)

Valbenazine

EXPERIMENTAL

Capsule, administered orally once daily.

Drug: Valbenazine

Interventions

ValbenazineDRUG

vesicular monoamine transporter 2 (VMAT2) inhibitor

Also known as: NBI-98854
Valbenazine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Have difficulty swallowing
  • Are currently pregnant or breastfeeding
  • Have a medically significant abnormality, physical examination finding, clinically significant laboratory abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Neurocrine Clinical Site

Vancouver, British Columbia, V6T 2B5, Canada

Location

Neurocrine Clinical Site

Ottawa, Ontario, K1Y 4E9, Canada

Location

Neurocrine Clinical Site

Toronto, Ontario, MK2 1E1, Canada

Location

MeSH Terms

Conditions

Huntington Disease

Interventions

valbenazine

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Clinical Development Lead

    Neurocrine Biosciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2024

First Posted

March 15, 2024

Study Start

April 24, 2024

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)