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New hope for uncontrolled muscle movements: valbenazine trial targets stubborn TD symptoms

NCT ID NCT07105111

Disease control 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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 1 time

Summary

This study tests whether valbenazine can reduce involuntary muscle movements (tardive dyskinesia) in adults who still have symptoms while taking or after stopping another similar drug. About 50 people with schizophrenia, bipolar disorder, or major depression will take valbenazine capsules for 24 weeks. Doctors and patients will report changes in movement severity and quality of life.

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 offer a new treatment option for people with tardive dyskinesia whose symptoms persist despite current medications.
What could go wrong
This is a small, open-label study (no placebo group), so results may be less reliable. It also focuses on people who already tried another drug, so benefits may not apply to everyone.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

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 years and older

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.

Key Inclusion Criteria: * 18 years of age or older * Diagnosed with one of the following at least 3 months prior to screening: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder * Diagnosed with at least mild neuroleptic-induced TD for at least 3 months prior to screening Key Exclusion Criteria: * Have comorbid Parkinsonism or abnormal involuntary movement(s) that is more prominent than TD * Diagnosis of moderate or severe substance use disorder in the last 6 months * History of long QT syndrome, cardiac arrythmia, or severe hepatic impairment

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Conditions

The condition(s) this trial relates to.

bipolar disorder major depressive disorder Psychotic Disorders schizoaffective disorder schizophrenia tardive dyskinesia

As listed by the trial registrant

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

Bipolar disorder Major depressive disorder Schizoaffective disorder Schizophrenia Tardive dyskinesia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    19 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Neurocrine Clinical Site

    RECRUITING

    Bryant, Arkansas, 72022, United States

  • Neurocrine Clinical Site

    RECRUITING

    Chino, California, 91710, United States

  • Neurocrine Clinical Site

    RECRUITING

    Fresno, California, 93701, United States

  • Neurocrine Clinical Site

    RECRUITING

    Long Beach, California, 90807, United States

  • Neurocrine Clinical Site

    RECRUITING

    Orange, California, 92866, United States

  • Neurocrine Clinical Site

    RECRUITING

    Redlands, California, 92373, United States

  • Neurocrine Clinical Site

    RECRUITING

    San Diego, California, 92123, United States

  • Neurocrine Clinical Site

    RECRUITING

    Bonita Springs, Florida, 34134, United States

  • Neurocrine Clinical Site

    RECRUITING

    Hialeah, Florida, 33012, United States

  • Neurocrine Clinical Site

    RECRUITING

    Miami, Florida, 33176, United States

  • Neurocrine Clinical Site

    RECRUITING

    Orange City, Florida, 32763, United States

  • Neurocrine Clinical Site

    RECRUITING

    Port Charlotte, Florida, 33980, United States

  • Neurocrine Clinical Site

    RECRUITING

    Tampa, Florida, 33629, United States

  • Neurocrine Clinical Site

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Neurocrine Clinical Site

    RECRUITING

    Naperville, Illinois, 60563, United States

  • Neurocrine Clinical Site

    RECRUITING

    Omaha, Nebraska, 68124, United States

  • Neurocrine Clinical Site

    RECRUITING

    Independence, Ohio, 44131, United States

  • Neurocrine Clinical Site

    RECRUITING

    Austin, Texas, 78754, United States

  • Neurocrine Clinical Site

    RECRUITING

    Richmond, Virginia, 23226, United States

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