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NCT07365462PHASE2Recruiting

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

Neurocrine Biosciences

Start Date

2/6/2026

Completion Date

3/1/2027

Summary

The primary objective of this study is to evaluate the efficacy of NBI-1065890 compared with placebo for the treatment of tardive dyskinesia (TD) in adult participants.

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

NBI-1065890

DRUG

Placebo

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Conditions

Tardive Dyskinesia

Locations

Neurocrine Clinical Site

Bryant, Arkansas 72022

United States

Neurocrine Clinical Site

Chino, California 91710

United States

Neurocrine Clinical Site

Fountain Valley, California 92708

United States

Neurocrine Clinical Site

Huntington Beach, California 92648

United States

Neurocrine Clinical Site

Long Beach, California 90807

United States

Neurocrine Clinical Site

Temecula, California 92591

United States

Neurocrine Clinical Site

Torrance, California 90501

United States

Neurocrine Clinical Site

Boca Raton, Florida 33486

United States

Neurocrine Clinical Site

Bonita Springs, Florida 34134

United States

Neurocrine Clinical Site

Hialeah, Florida 33012

United States

Neurocrine Clinical Site

Miami, Florida 33176

United States

Neurocrine Clinical Site

Orange City, Florida 32763

United States

Neurocrine Clinical Site

Tampa, Florida 33629

United States

Neurocrine Clinical Site

Marietta, Georgia 30060

United States

Neurocrine Clinical Site

Lincoln, Nebraska 68526

United States

Neurocrine Clinical Site

Beachwood, Ohio 44122

United States

Neurocrine Clinical Site

Fort Worth, Texas 76104

United States

Neurocrine Clinical Site

Houston, Texas 77030

United States