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

Launched by NEUROCRINE BIOSCIENCES · Aug 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety of a medication called NBI-1117568 in adults who have schizophrenia, a condition that affects how a person thinks, feels, and behaves. The main goal is to see how safe this medicine is when taken over a longer period. The study is currently looking for participants.

Adults with a diagnosis of schizophrenia may be eligible to join, especially if they live in a stable home environment and are not currently taking other antipsychotic medicines (they would need to stop these before starting the trial). People who have serious medical problems, recent substance abuse issues (except for nicotine or caffeine), or who might be at risk of harming themselves or others would not be able to participate. Participants can expect to be closely monitored throughout the study to ensure their safety and to see how well the medicine works over time. If you or a family member are considering joining, it’s important to discuss any current medications and health conditions with the study team to determine eligibility.

Gender

ALL

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.