Status:
COMPLETED
Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease
Lead Sponsor:
Neurocrine Biosciences
Collaborating Sponsors:
Huntington Study Group
Conditions:
Chorea, Huntington
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of valbenazine to treat chorea in participants with Huntington disease.
Eligibility Criteria
Inclusion
- Have a clinical diagnosis of Huntington Disease (HD) with chorea
- Be able to walk, with or without the assistance of a person or device
- Participants of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently while participating in the study until 30 days (females) or 90 days (males) after the last dose of the study drug
- Be able to read and understand English
Exclusion
- Have a history of previously established therapy with a VMAT2 inhibitor, in the judgement of the investigator
- Have difficulty swallowing
- Are currently pregnant or breastfeeding
- Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch block, atrioventricular block, uncontrolled bradyarrhythmia, or heart failure
- Have an unstable or serious medical or psychiatric illness
- Have a significant risk of suicidal behavior
- Have a history of substance dependence or substance (drug) or alcohol abuse, within 1 year of screening
- If taking antidepressant therapy, be on a stable regimen
- Have received gene therapy at any time
- Have received an investigational drug in a clinical study within 30 days of the baseline visit or plan to use such investigational drug (other than valbenazine) during the study
- Have had a blood loss ≥550 milliliters (mL) or donated blood within 30 days before the baseline visit
- Had a medically significant illness within 30 days before baseline, or any history of neuroleptic malignant syndrome
Key Trial Info
Start Date :
November 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2021
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04102579
Start Date
November 13 2019
End Date
October 26 2021
Last Update
October 11 2023
Active Locations (46)
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1
Neurocrine Clinical Site
Birmingham, Alabama, United States, 35233
2
Neurocrine Clinical Site
Little Rock, Arkansas, United States, 72205
3
Neurocrine Clinical Site
La Jolla, California, United States, 92037
4
Neurocrine Clinical Site
Sacramento, California, United States, 95817