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A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder Who Are Currently Experiencing a Manic Episode or Manic Episode With Mixed Features, With or Without Psychotic Symptoms, and Warrant Inpatient Hospitalization
Conditions
Interventions
NBI-1117568
Placebo
Locations
6
United States
Neurocrine Clinical Site
Garden Grove, California, United States
Neurocrine Clinical Site
Hollywood, California, United States
Neurocrine Clinical Site
San Diego, California, United States
Neurocrine Clinical Site
Atlanta, Georgia, United States
Neurocrine Clinical Site
Gaithersburg, Maryland, United States
Neurocrine Clinical Site
Marlton, New Jersey, United States
Start Date
December 24, 2025
Primary Completion Date
February 1, 2028
Completion Date
February 1, 2028
Last Updated
March 24, 2026
NCT07140913
NCT07540338
NCT00344188
NCT07494305
NCT07172516
NCT07213466
Lead Sponsor
Neurocrine Biosciences
Data Source & Attribution
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