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RecruitingPhase 3NCT07114874

NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia

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Trial Parameters

ConditionSchizophrenia
SponsorNeurocrine Biosciences
Study TypeINTERVENTIONAL
PhasePhase 3
Enrollment800
SexALL
Min Age18 Years
Max Age65 Years
Start Date2025-07-11
Completion2031-12
Interventions
NBI-1117568

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Brief Summary

This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.

Eligibility Criteria

Key Inclusion Criteria: * Participant has a primary diagnosis of schizophrenia * Participants taking prohibited medications, including antipsychotics, must discontinue before study participation * Participant must reside in a stable housing situation Key Exclusion Criteria: * Participant has known hypersensitivity to any component of the formulation of NBI-1117568 * Participant has an unstable or poorly controlled medical condition or chronic disease * Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others * Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening * Participant has a positive alcohol test or drug screen for disallowed substances * Participant has a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the participant is not capable of adhering to the prot

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