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Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Valbenazine for Huntington's Disease
Phase 3
Waitlist Available
Research Sponsored by Neurocrine Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will look at how safe and well-tolerated valbenazine is for people with Huntington Disease who have uncontrollable movements.
Who is the study for?
This trial is for individuals in Canada with Huntington's Disease who experience chorea (involuntary movements) and were part of a previous study, NBI-98854-HD3006. Specific eligibility details are not provided, but typically participants must meet certain health standards to be included.
What is being tested?
The focus of this study is on the long-term safety and tolerability of a drug called Valbenazine for patients with chorea due to Huntington's Disease. It extends research from an earlier trial.
What are the potential side effects?
While specific side effects for Valbenazine in this context aren't listed here, common ones may include sleepiness, balance problems, dry mouth, and gastrointestinal issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ValbenazineExperimental Treatment1 Intervention
Capsule, administered orally once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valbenazine
2018
Completed Phase 4
~880
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Who is running the clinical trial?
Neurocrine BiosciencesLead Sponsor
75 Previous Clinical Trials
6,714 Total Patients Enrolled
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,567 Total Patients Enrolled
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