NCT07365462 Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
| NCT ID | NCT07365462 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Neurocrine Biosciences |
| Condition | Tardive Dyskinesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-01-23 |
| Primary Completion | 2027-02 |
Trial Parameters
Eligibility Fast-Check
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Brief 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
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 S