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NCT07114874
NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia
Conditions: Schizophrenia
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 600
Sponsor: Neurocrine Biosciences
Location: Neurocrine Clinical Site Bryant Arkansas
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 protocol requirements.
Note: Other protocol-specified inclusion/exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT07114874). StuddyBuddy aggregates publicly available trial information.