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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 262 weeks
Awards & highlights

Study Summary

This trial will study the long-term safety and effectiveness of a drug for treating Huntington disease.

Who is the study for?
This trial is for individuals with Huntington's Disease and chorea who either completed a prior study (NBI-98854-HD3005) or have not used VMAT2 inhibitors in the last 30 days. Participants must be able to walk, understand English, consent to the study, and agree to use contraception if of childbearing potential.Check my eligibility
What is being tested?
The trial is testing Valbenazine's long-term safety and effectiveness in treating chorea associated with Huntington’s Disease. It's an open-label Phase 3 study providing ongoing access to Valbenazine for those who need it.See study design
What are the potential side effects?
While specific side effects are not listed here, Valbenazine may cause similar side effects as other medications that affect brain chemistry such as drowsiness, restlessness, nausea, and potentially heart-related issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 262 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 262 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Secondary outcome measures
Change from Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score

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

Find a Location

Who is running the clinical trial?

Huntington Study GroupNETWORK
13 Previous Clinical Trials
8,636 Total Patients Enrolled
Neurocrine BiosciencesLead Sponsor
75 Previous Clinical Trials
6,597 Total Patients Enrolled
Chief Medical OfficerStudy DirectorChief Medical Officer
122 Previous Clinical Trials
21,370 Total Patients Enrolled

Media Library

Valbenazine (Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04400331 — Phase 3
Huntington's Disease Research Study Groups: Valbenazine
Huntington's Disease Clinical Trial 2023: Valbenazine Highlights & Side Effects. Trial Name: NCT04400331 — Phase 3
Valbenazine (Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04400331 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people who are not yet 50 years old join this clinical trial?

"This study requires that all participants are between 18-75 years old."

Answered by AI

Has Valbenazine's safety been verified by the FDA?

"Valbenazine's safety is estimated to be a 3. This judgement comes from the fact that this medication is in Phase 3 trials, meaning that there is both evidence of its efficacy and multiple rounds of data supporting its safety."

Answered by AI

How many people are included in this research project?

"That is correct. The information available on clinicaltrials.gov attests that this trial is still actively looking for subjects. This particular study was first posted on September 18th, 2020 and was most recently edited on October 31st, 2022. In total, they are looking to have 150 participants at 33 locations across the country."

Answered by AI

What are the ideal characteristics for participants of this clinical trial?

"To be eligible for this study, participants must have Huntington's disease, be aged 18-75, and meet either requirement #1 or #2. Additionally, candidates must be able to walk unassisted or with the help of a mobility device. Those who have participated in Study NBI-98854-HD3005 are ineligible."

Answered by AI

Are researchers looking for more participants for this trial?

"The trial is currently seeking patients, according to the information on clinicaltrials.gov. This study was first posted on September 18th 2020 and was most recently updated on October 31st 2022."

Answered by AI

Has a study like this been done before?

"Valbenazine has been under investigation since 2020. The first study was a Phase 1 clinical trial sponsored by Neurocrine Biosciences. After the initial success in 2020, which involved 150 participants, Valbenazine received approval for Phase 3 trials. Currently, there are 3 live trials taking place across 52 cities in 2 countries."

Answered by AI

What other research has been conducted on Valbenazine?

"Valbenazine was first studied in 2020 by Neurocrine, and since then there have been 19 completed clinical trials. As of now, 3 more studies are underway with active recruitment. These trials are primarily based out of Toronto, Canada."

Answered by AI

Does this trial have a broad reach in Canada?

"33 clinical trial sites are currently operational. These locations include major cities such as Toronto, Omaha and Chicago. There may be a location near you, which would reduce travel time if you decided to participate in this study."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Neurocrine Clinical Site
What portion of applicants met pre-screening criteria?
Met criteria
~52 spots leftby Mar 2026