Long-term treatment with NBI-1117568 for adults with schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial administers NBI-1117568 to adults with a primary diagnosis of schizophrenia and follows them over an extended period to monitor safety. Participants must discontinue prohibited medications, including other antipsychotics, and live in a stable housing situation. Key exclusions include known hypersensitivity to the drug, unstable medical conditions, recent moderate-to-severe substance use disorder, positive disallowed drug/alcohol screens, imminent suicide risk, or inability to comply with study procedures. Safety monitoring will include regular clinical assessments and adverse event reporting at Neurocrine clinical sites in Arkansas and California.

Why it matters

Who can join: the full rules

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.

Where it's running

• Neurocrine Clinical Site
  Bryant, Arkansas, United States Recruiting
• Neurocrine Clinical Site
  Little Rock, Arkansas, United States Recruiting
• Neurocrine Clinical Site
  Cerritos, California, United States Recruiting
• Neurocrine Clinical Site
  Chino, California, United States Recruiting
• Neurocrine Clinical Site
  Culver City, California, United States Recruiting
• Neurocrine Clinical Site
  Garden Grove, California, United States Recruiting

+11 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Neurocrine Medical Information Call Center
• Email: medinfo@neurocrine.com
• Phone: 877-641-3461

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.