Clinical Trial

An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania

Recruiting Phase 2
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Summary
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or without mixed features.
Protocol Amendment History 1 change
notable Trial sites expanded: 6 -> 9 locations 2026-08-01
Trial Details
NCT Number NCT07288320
Lead Sponsor Neurocrine Biosciences
Conditions Bipolar I Disorder, Mania
Enrollment 150 participants
Start Date 2025-12-24
Primary Completion 2028-02 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-31