Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Chorea, Huntington

In brief

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.

Key facts

Study ID

NCT04102579

Run by

Neurocrine Biosciences

People needed

128

Starts

2019-11-13

Expected to finish

2021-10-26

Last updated by the study team

2023-10-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Neurocrine Clinical Site — Birmingham, Alabama, United States
• Neurocrine Clinical Site — Little Rock, Arkansas, United States
• Neurocrine Clinical Site — La Jolla, California, United States
• Neurocrine Clinical Site — Sacramento, California, United States
• Neurocrine Clinical Site — Aurora, Colorado, United States
• Neurocrine Clinical Site — Englewood, Colorado, United States
• Neurocrine Clinical Site — Washington D.C., District of Columbia, United States
• Neurocrine Clinical Site — Gainesville, Florida, United States
• Neurocrine Clinical Site — Miami, Florida, United States
• Neurocrine Clinical Site — Atlanta, Georgia, United States
• Neurocrine Clinical Site — Chicago, Illinois, United States
• Neurocrine Clinical Site — Chicago, Illinois, United States
• Neurocrine Clinical Site — Indianapolis, Indiana, United States
• Neurocrine Clinical Site — Iowa City, Iowa, United States
• Neurocrine Clinical Site — Kansas City, Kansas, United States
• Neurocrine Clinical Site — Wichita, Kansas, United States
• Neurocrine Clinical Site — Louisville, Kentucky, United States
• Neurocrine Clinical Site — New Orleans, Louisiana, United States
• Neurocrine Clinical Site — Boston, Massachusetts, United States
• Neurocrine Clinical Site — Boston, Massachusetts, United States
• Neurocrine Clinical Site — Charlestown, Massachusetts, United States
• Neurocrine Clinical Site — Ann Arbor, Michigan, United States
• Neurocrine Clinical Site — West Bloomfield, Michigan, United States
• Neurocrine Clinical Site — Omaha, Nebraska, United States
• Neurocrine Clinical Site — Rochester, New York, United States

Full record on ClinicalTrials.gov

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