Recruiting NCT07114874

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

Phase III Interventional Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: NBI-1117568.
Who it may be relevant to: Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Bulgaria, Romania, Serbia
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia

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

Drug NBI-1117568
NBI-1117568 will be administered per schedule specified in the arm description.

Number of Participants with Treatment-emergent Adverse Events [Time frame: Up to 36 months]

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 49 centers

Romania · 3 centers

Serbia · 3 centers

Bulgaria · 2 centers

NCT: NCT07114874 · NBI-1117568-SCZ3032 · 2025-521216-19-00