Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease

Completed · Phase 3

Conditions studied: Chorea, Huntington

In brief

This is a Phase 3, open-label study to evaluate the long-term safety and tolerability of valbenazine, and to provide participants continued access to valbenazine for the treatment of chorea associated with Huntington disease.

Key facts

Study ID

NCT04400331

Run by

Neurocrine Biosciences

People needed

154

Starts

2020-09-18

Expected to finish

2025-11-05

Last updated by the study team

2026-06-17

Who can join

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

You may qualify if…

• Either #1 or #2 must be met for inclusion eligibility.
• Have participated in Study NBI-98854-HD3005 and
• a. Study drug dosing completion of Study NBI-98854-HD3005, as demonstrated by completed study drug dosing through the follow-up visit or early terminated Study NBI-98854-HD3005 for administrative reasons due to COVID-19 (for example, site closure related to COVID-19)
• Did not participate in Study NBI-98854-HD3005 and
• Have a clinical and genetic diagnosis of Huntington Disease (HD) with chorea
• Be able to walk, with or without the assistance of a person or device
• Be able to read and understand English and capable of providing consent to study participation or have a legally authorized representative providing consent and the participant providing assent
• 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

You may not qualify if…

• Have difficulty swallowing
• Are currently pregnant or breastfeeding
• Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch block, atrioventricular (AV) 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
• Have received gene therapy at any time
• Have received an investigational drug in a clinical study (other than valbenazine) within 30 days before the baseline visit or plan to use such investigational drug (other than valbenazine) during the study
• Have had a blood loss ≥550 mL or donated blood within 30 days before the baseline visit
• Have a history of severe hepatic impairment or history of protocol specified hematologic abnormalities during the course of the NBI-98854-HD3005 study
• Had a medically significant illness within 30 days before baseline, or any history of neuroleptic malignant syndrome
• Have a known hypersensitivity to any component of the formulation of valbenazine
• For participants who did not participate in NBI-98854-HD3005: have a history of VMAT2 inhibitor use within 30 days of baseline

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 — Aurora, Colorado, United States
• Neurocrine Clinical Site — Washington D.C., District of Columbia, United States
• Neurocrine Clinical Site — Boca Raton, Florida, United States
• Neurocrine Clinical Site — Gainesville, 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 — 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 — Charlestown, Massachusetts, United States
• Neurocrine Clinical Site — Ann Arbor, Michigan, United States
• Neurocrine Clinical Site — Omaha, Nebraska, United States
• Neurocrine Clinical Site — Rochester, New York, United States
• Neurocrine Clinical Site — Williamsville, New York, United States
• Neurocrine Clinical Site — Durham, North Carolina, United States
• Neurocrine Clinical Site — Columbus, Ohio, United States
• Neurocrine Clinical Site — Toledo, Ohio, United States
• Neurocrine Clinical Site — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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