NBI-1065890 versus placebo for 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
This trial will test if NBI-1065890 reduces involuntary movements in adults with tardive dyskinesia compared with a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Neurocrine Biosciences Industry-sponsored |
| Locations | 6 sites (Chino, California and 5 other locations) |
| Trial ID | NCT07365462 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial compares the investigational drug NBI-1065890 to placebo in adults who have neuroleptic-induced tardive dyskinesia and a qualifying psychiatric diagnosis. Participants must have had TD for at least three months and meet a minimum severity threshold on the AIMS dyskinesia total score as confirmed by a blinded external video reviewer. Dosing is compared against placebo while blinded certified site raters and external reviewers use AIMS video assessments to measure changes in abnormal movements; safety and tolerability are also monitored. The study is being conducted at Neurocrine Clinical Sites in California and Florida.
Who should consider this trial
Good fit: Adults with a confirmed diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder and neuroleptic-induced TD for at least three months with AIMS dyskinesia total score ≥6 are ideal candidates.
Not a fit: Patients with comorbid parkinsonism, only mild TD, or TD not caused by neuroleptic exposure are unlikely to benefit from this specific trial.
Why it matters
Potential benefit: If effective, NBI-1065890 could reduce the severity of involuntary movements and improve daily functioning for people with tardive dyskinesia.
How similar studies have performed: Drugs targeting the same general pathway (VMAT2 inhibitors such as valbenazine and deutetrabenazine) have shown benefit in TD, so this approach builds on established pharmacology though NBI-1065890 itself is investigational.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chino, California and 5 other locations
- Neurocrine Clinical Site — Chino, California, United States (Recruiting)
- Neurocrine Clinical Site — Torrance, California, United States (Recruiting)
- Neurocrine Clinical Site — Hialeah, Florida, United States (Recruiting)
- Neurocrine Clinical Site — Miami, Florida, United States (Recruiting)
- Neurocrine Clinical Site — Tampa, Florida, United States (Recruiting)
- Neurocrine Clinical Site — Lincoln, Nebraska, United States (Recruiting)
Study contacts
- Study coordinator: Neurocrine Medical Information Call Center
- Email: medinfo@neurocrine.com
- Phone: 1-877-641-3461
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.