RecruitingPhase 2NCT07365462
Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1065890 in Adult Participants With Tardive Dyskinesia
Sponsor
Neurocrine Biosciences
Enrollment
100 participants
Start Date
Jan 23, 2026
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria3
- 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 Criteria6
- 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).
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Interventions
DRUGNBI-1065890
Oral administration
DRUGPlacebo
Oral administration
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07365462
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