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NBI-1065890 for Tardive Dyskinesia

This study is testing a drug called NBI-1065890 to see if it can help adults with tardive dyskinesia (TD). TD is a condition that causes involuntary movements. You would either receive NBI-1065890 or a placebo (an inactive substance, like a sugar pill). Researchers will measure changes in your involuntary movements using a special scale called the Abnormal Involuntary Movement Scale (AIMS) over 8 weeks. To join, you must be between 18 and 75 years old and have a confirmed diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder (MDD) for at least 3 months. The current status of this study is unclear.

Study design
This is an interventional study comparing NBI-1065890 to a placebo. It plans to enroll about 100 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your involuntary movements will be assessed at the beginning of the study and again at Week 8.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07365462

Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Neurocrine Biosciences
~100 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:NBI-1065890Placebo

At a glance

Recruiting sites
18 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 8 Based on the Blinded Central AIMS Video Raters' Assessment
Measured over Baseline and Week 8

Conditions

Tardive Dyskinesia

Explore related trials

Tardive dyskinesia

Where it's being run

18 sites across 7 states
California6
Florida6
Texas2
Arkansas1
Georgia1
Nebraska1
Ohio1

Study leadership

  • Clinical Development Lead · STUDY_DIRECTOR · Neurocrine Biosciences

Who to contact

Neurocrine Medical Information Call Center
[email protected]
1-877-641-3461
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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).

What this trial measures

  • Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 8 Based on the Blinded Central AIMS Video Raters' AssessmentBaseline and Week 8