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

Neurocrine Biosciences

Status and phase

Enrolling

Phase 3

Conditions

Schizophrenia

Treatments

Drug: NBI-1117568

Study type

Interventional

Funder types

Industry

Identifiers

2025-521216-19-00 (EU Trial (CTIS) Number)

NBI-1117568-SCZ3032

Details and patient eligibility

About

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

Enrollment

800 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.