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Valbenazine shows promise for easing involuntary movements in tardive dyskinesia

NCT ID NCT05859698

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 4 study tested valbenazine in 59 adults with tardive dyskinesia (involuntary muscle movements) caused by psychiatric medications. Participants had schizophrenia, bipolar disorder, or major depression. Over 24 weeks, researchers measured changes in quality of life, daily functioning, and overall health using patient and clinician reports. The goal was to see if valbenazine reduces the impact of these movements on everyday 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, valbenazine could offer a well-tolerated option to reduce the impact of tardive dyskinesia on daily life and emotional well-being.
What could go wrong
This is a small, single-arm, open-label study with no placebo group, so results may be less reliable. Tardive dyskinesia can be persistent, and not everyone may respond.

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

59 people

The number who actually took part.

Started

May 2023

Finished

Dec 2024

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: * At least 18 years of age * Have one of the following clinical diagnoses: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder * Have a clinical diagnosis of neuroleptic-induced TD * Medication(s) for schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder and other protocol-allowed concurrent medications must be at a stable dose and expected to remain stable during the study * Participants must be outpatients and have a stable psychiatric status Key Exclusion Criteria: * Have comorbid abnormal involuntary movement(s) (for example, Parkinsonism, akathisia) that is more prominent than TD * Have an active, clinically significant unstable medical condition in the judgement of the investigator, or have any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Neurocrine Clinical Site

    Bryant, Arkansas, 72022, United States

  • Neurocrine Clinical Site

    Anaheim, California, 92805, United States

  • Neurocrine Clinical Site

    Orange, California, 92868, United States

  • Neurocrine Clinical Site

    Torrance, California, 90504, United States

  • Neurocrine Clinical Site

    Bonita Springs, Florida, 34134, United States

  • Neurocrine Clinical Site

    Miami, Florida, 33176, United States

  • Neurocrine Clinical Site

    Miami Lakes, Florida, 33016, United States

  • Neurocrine Clinical Site

    Okeechobee, Florida, 34972, United States

  • Neurocrine Clinical Site

    Tampa, Florida, 33629, United States

  • Neurocrine Clinical Site

    Atlanta, Georgia, 30328, United States

  • Neurocrine Clinical Site

    Augusta, Georgia, 30912, United States

  • Neurocrine Clinical Site

    Marietta, Georgia, 30060, United States

  • Neurocrine Clinical Site

    Lincoln, Nebraska, 68526, United States

  • Neurocrine Clinical Site

    Beechwood, Ohio, 44122, United States

  • Neurocrine Clinical Site

    Oklahoma City, Oklahoma, 73112, United States

  • Neurocrine Clinical Site

    DeSoto, Texas, 75115, United States

  • Neurocrine Clinical Site

    El Paso, Texas, 79902, United States

  • Neurocrine Clinical Site

    Houston, Texas, 77030, United States

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