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 | 2026-02-06 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2026-02-06 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Clinical Development Lead
STUDY DIRECTOR
Neurocrine Biosciences
Frequently Asked Questions
Who can join the NCT07365462 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Tardive Dyskinesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07365462 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07365462 currently recruiting?
Yes, NCT07365462 is actively recruiting participants. Contact the research team at medinfo@neurocrine.com for enrollment information.
Where is the NCT07365462 trial being conducted?
This trial is being conducted at Bryant, United States, Chino, United States, Fountain Valley, United States, Huntington Beach, United States and 11 additional locations.
Who is sponsoring the NCT07365462 clinical trial?
NCT07365462 is sponsored by Neurocrine Biosciences. The principal investigator is Clinical Development Lead at Neurocrine Biosciences. The trial plans to enroll 100 participants.