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New pill could tame involuntary twitching in mental health patients

NCT ID NCT07365462

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests an experimental drug, NBI-1065890, to see if it can reduce involuntary movements in adults with tardive dyskinesia, a condition often caused by long-term use of certain mental health medications. About 100 participants with schizophrenia, bipolar disorder, or depression will receive either the drug or a placebo for 8 weeks. The main goal is to measure changes in movement severity using a standard rating scale.

What this could mean

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

Active substance
NBI-1065890
What this could lead to
If it works, this could provide a new option to reduce uncontrolled movements in people with tardive dyskinesia.
What could go wrong
This is an early Phase 2 trial with only 100 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

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

Started

Feb 2026

Expected to finish

Mar 2027

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 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.

Key Inclusion Criteria: * Medically confirmed diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder (MDD) as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for at least 3 months prior to screening. * Medically confirmed diagnosis of neuroleptic-induced TD as defined in the DSM-5 for at least 3 months prior to screening. * Moderate or severe TD (AIMS Item 8, severity of abnormal movement overall) as assessed by a blinded, external AIMS video reviewer using a video recording of the participant's AIMS assessment administered at the clinical site by a blinded, certified site AIMS rater. The AIMS dyskinesia total score (sum of Items 1 to 7) must be ≥6 as assessed by the blinded, external AIMS video reviewer. Key Exclusion Criteria: * Comorbid parkinsonism (drug-induced or otherwise) or more than a minimal level of extrapyramidal signs/symptoms, as documented by a score on the Modified Simpson-Angus Scale (mSAS) (excluding Items 8 and 10) \>6 at screening or Day -1 (baseline) or a score \>3 in any one item (excluding Items 8 and 10). * Barnes Akathisia Rating Scale (BARS) global clinical assessment score ≥2 at screening or Day -1. * Brief Psychiatric Rating Scale (BPRS) total score ≥50 at screening or Day -1. * Hospitalized for schizophrenia, schizoaffective disorder, bipolar disorder, or MDD within 6 months of screening. * Participant has an unstable medical condition or unstable chronic disease. * Any known history of neuroleptic malignant syndrome (NMS). Note: Other protocol-defined inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

tardive dyskinesia

As listed by the trial registrant

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

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

    18 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

    Fountain Valley, California, 92708, United States

  • Neurocrine Clinical Site

    RECRUITING

    Huntington Beach, California, 92648, United States

  • Neurocrine Clinical Site

    RECRUITING

    Long Beach, California, 90807, United States

  • Neurocrine Clinical Site

    RECRUITING

    Temecula, California, 92591, United States

  • Neurocrine Clinical Site

    RECRUITING

    Torrance, California, 90501, United States

  • Neurocrine Clinical Site

    RECRUITING

    Boca Raton, Florida, 33486, 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

    Tampa, Florida, 33629, United States

  • Neurocrine Clinical Site

    RECRUITING

    Marietta, Georgia, 30060, United States

  • Neurocrine Clinical Site

    RECRUITING

    Lincoln, Nebraska, 68526, United States

  • Neurocrine Clinical Site

    RECRUITING

    Beachwood, Ohio, 44122, United States

  • Neurocrine Clinical Site

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Neurocrine Clinical Site

    RECRUITING

    Houston, Texas, 77030, United States

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