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New drug shows promise for controlling Huntington's chorea

NCT ID NCT04400331

Symptom relief Sponsor: Neurocrine Biosciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 study tested the long-term safety of valbenazine in 154 people with Huntington disease who have chorea (uncontrolled movements). Participants either continued from a previous study or joined new. The goal was to see if valbenazine is safe and helps control chorea over time. Results may support its use as a long-term symptom management option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
valbenazine
What this could lead to
If successful, this could provide a long-term treatment option to reduce involuntary movements (chorea) in people with Huntington disease.
What could go wrong
This is an open-label study without a placebo group, so results may be less reliable. Side effects are possible, and the drug only manages symptoms, not the underlying disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

154 people

The number who actually took part.

Started

Sep 2020

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Either #1 or #2 must be met for inclusion eligibility. 1. 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) 2. Did not participate in Study NBI-98854-HD3005 and 1. Have a clinical and genetic diagnosis of Huntington Disease (HD) with chorea 2. Be able to walk, with or without the assistance of a person or device 3. 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 4. 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 Exclusion Criteria: 1. Have difficulty swallowing 2. Are currently pregnant or breastfeeding 3. Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch block, atrioventricular (AV) block, uncontrolled bradyarrhythmia, or heart failure 4. Have an unstable or serious medical or psychiatric illness 5. Have a significant risk of suicidal behavior 6. Have a history of substance dependence or substance (drug) or alcohol abuse, within 1 year of screening 7. Have received gene therapy at any time 8. 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 9. Have had a blood loss ≥550 mL or donated blood within 30 days before the baseline visit 10. Have a history of severe hepatic impairment or history of protocol specified hematologic abnormalities during the course of the NBI-98854-HD3005 study 11. Had a medically significant illness within 30 days before baseline, or any history of neuroleptic malignant syndrome 12. Have a known hypersensitivity to any component of the formulation of valbenazine 13. For participants who did not participate in NBI-98854-HD3005: have a history of VMAT2 inhibitor use within 30 days of baseline

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Conditions

The condition(s) this trial relates to.

Huntington disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chorea, Huntington

Contacts and locations

Locations

  • Neurocrine Clinical Site

    Birmingham, Alabama, 35294, United States

  • Neurocrine Clinical Site

    Little Rock, Arkansas, 72205, United States

  • Neurocrine Clinical Site

    La Jolla, California, 92037, United States

  • Neurocrine Clinical Site

    Aurora, Colorado, 80045, United States

  • Neurocrine Clinical Site

    Washington D.C., District of Columbia, 20007, United States

  • Neurocrine Clinical Site

    Boca Raton, Florida, 33486, United States

  • Neurocrine Clinical Site

    Gainesville, Florida, 32608, United States

  • Neurocrine Clinical Site

    Atlanta, Georgia, 30329, United States

  • Neurocrine Clinical Site

    Chicago, Illinois, 60611, United States

  • Neurocrine Clinical Site

    Chicago, Illinois, 60612, United States

  • Neurocrine Clinical Site

    Indianapolis, Indiana, 46202, United States

  • Neurocrine Clinical Site

    Iowa City, Iowa, 52242, United States

  • Neurocrine Clinical Site

    Wichita, Kansas, 67226, United States

  • Neurocrine Clinical Site

    Louisville, Kentucky, 40202, United States

  • Neurocrine Clinical Site

    New Orleans, Louisiana, 70121, United States

  • Neurocrine Clinical Site

    Boston, Massachusetts, 02215, United States

  • Neurocrine Clinical Site

    Charlestown, Massachusetts, 02129, United States

  • Neurocrine Clinical Site

    Ann Arbor, Michigan, 48105, United States

  • Neurocrine Clinical Site

    Omaha, Nebraska, 68105, United States

  • Neurocrine Clinical Site

    Rochester, New York, 14618, United States

  • Neurocrine Clinical Site

    Williamsville, New York, 14221, United States

  • Neurocrine Clinical Site

    Durham, North Carolina, 27705, United States

  • Neurocrine Clinical Site

    Columbus, Ohio, 43221, United States

  • Neurocrine Clinical Site

    Toledo, Ohio, 43614, United States

  • Neurocrine Clinical Site

    Pittsburgh, Pennsylvania, 15213, United States

  • Neurocrine Clinical Site

    Charleston, South Carolina, 29425, United States

  • Neurocrine Clinical Site

    Columbia, South Carolina, 29203, United States

  • Neurocrine Clinical Site

    Greenville, South Carolina, 29615, United States

  • Neurocrine Clinical Site

    Nashville, Tennessee, 37212, United States

  • Neurocrine Clinical Site

    Houston, Texas, 77054, United States

  • Neurocrine Clinical Site

    Burlington, Vermont, 05401, United States

  • Neurocrine Clinical Site

    Vancouver, British Columbia, V6T 2B5, Canada

  • Neurocrine Clinical Site

    Ottawa, Ontario, K1Y 4E9, Canada

  • Neurocrine Clinical Site

    Toronto, Ontario, MK2 1E1, Canada

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