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Long-Term Safety Study of NBI-1117568 for Schizophrenia

This study is looking at the long-term safety of a drug called NBI-1117568 for adults with schizophrenia. You might be able to join if you are between 18 and 65 years old, have a primary diagnosis of schizophrenia, and live in stable housing. You would need to stop taking certain medications, including antipsychotics, before starting the study. The main goal is to see how many participants experience side effects over a period of up to 36 months. The study is currently unclear about its recruitment status and plans to enroll about 600 people.

Study design
This is an interventional study, meaning participants will receive the study drug NBI-1117568. The study aims to enroll 600 participants.
What's involved
NBI-1117568 will be given according to a schedule. The study will monitor for side effects for up to 36 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-emergent adverse events (side effects) for up to 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07114874

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

Recruiting
PHASE3Ages 18–65InterventionalTreatment
Neurocrine Biosciences
~600 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:NBI-1117568

At a glance

Recruiting sites
56 of 57 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment-emergent Adverse Events
Measured over Up to 36 months

Conditions

Schizophrenia

Explore related trials

Schizophrenia

Where it's being run

57 sites across 19 states
California13
Florida10
New York5
Georgia4
Texas3
Romania3
Serbia3
Arkansas2

Study leadership

  • Clinical Development Lead · STUDY_DIRECTOR · Neurocrine Biosciences

Who to contact

Neurocrine Medical Information Call Center
[email protected]
877-641-3461
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants with Treatment-emergent Adverse EventsUp to 36 months