RecruitingPhase 3NCT07114874
NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia
A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia
Sponsor
Neurocrine Biosciences
Enrollment
800 participants
Start Date
Jul 11, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria3
- 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
Exclusion Criteria6
- 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 protocol requirements.
Interventions
DRUGNBI-1117568
NBI-1117568 will be administered per schedule specified in the arm description.
Locations(24)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07114874
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