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Enrolling by invitation NCT06312189

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

Phase III Interventional Chorea, Huntington

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Valbenazine.
Who it may be relevant to
Registry conditions: Chorea, Huntington. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Valbenazine
    vesicular monoamine transporter 2 (VMAT2) inhibitor

Primary outcome measures

  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to Week 210]

Eligibility criteria

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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 3 centers
  • Neurocrine Clinical Site — Vancouver
  • Neurocrine Clinical Site — Ottawa
  • Neurocrine Clinical Site — Toronto

Identifiers

NCT: NCT06312189 · NBI-98854-HD3022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗