Actively Recruiting
Phase 2 Study of NBI-1065890 Versus Placebo for Treating Adults With Tardive Dyskinesia and Related Psychiatric Disorders
Led by Neurocrine Biosciences · Updated on 2026-06-23
100
Participants Needed
18
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of NBI-1065890 compared to a placebo for treating tardive dyskinesia TD in adults. This Phase 2 study focuses on adults aged 18 to 75 with a confirmed diagnosis of TD caused by neuroleptic medication and other related psychiatric conditions such as schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. The study aims to assess the treatments impact on abnormal involuntary movements and overall improvement. Participants will be randomly assigned to receive either NBI-1065890 or a matching placebo, both taken orally. The study uses a parallel design with quadruple masking to compare the effects over an 8-week period. The main measurement is the change in the Abnormal Involuntary Movement Scale AIMS total score from baseline to week 8, along with secondary assessments of clinical global improvement. During the study, participants will undergo blinded video assessments of their movements, and their responses will be evaluated by expert raters. Researchers will monitor the severity of dyskinesia, psychiatric symptoms, and any side effects. The study includes regular visits over the 8-week treatment period, with safety and tolerability closely observed. Total participation lasts at least 8 weeks, concluding with the final evaluation of movement improvement.
CONDITIONS
Brief Title
Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
Research Team
N
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