Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NBI-1065890, Placebo.
- Who it may be relevant to
- Registry conditions: Tardive Dyskinesia. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug NBI-1065890
Oral administration - Drug Placebo
Oral administration
Primary outcome measures
- Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 8 Based on the Blinded Central AIMS Video Raters' Assessment [Time frame: Baseline and Week 8]
Secondary outcome measures (1)
- Percentage of Participants Who Are a Clinical Global Impression - Improvement (CGI-I) Responder 1 at Week 8 [Time frame: Week 8]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 18 centers
- Neurocrine Clinical Site — Bryant
- Neurocrine Clinical Site — Chino
- Neurocrine Clinical Site — Fountain Valley
- Neurocrine Clinical Site — Huntington Beach
- Neurocrine Clinical Site — Long Beach
- Neurocrine Clinical Site — Temecula
- Neurocrine Clinical Site — Torrance
- Neurocrine Clinical Site — Boca Raton
- … and 10 more centers
Identifiers
NCT: NCT07365462 · NBI-1065890-TD2033 · 2025-524104-30-00