NBI-1117568 for adults hospitalized 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, placebo-controlled inpatient trial compares NBI-1117568 with placebo in adults who are experiencing an acute exacerbation of schizophrenia and require hospitalization. Participants must discontinue prohibited antipsychotics before enrollment and remain in a supervised inpatient setting while receiving study medication or placebo. The primary outcome is change in behavioral and psychological symptoms of schizophrenia from baseline compared with placebo, with safety and tolerability monitored throughout the inpatient period.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Participant has a primary diagnosis of schizophrenia
* Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization.
* Participants taking prohibited medications, including antipsychotics, must discontinue before study participation
* Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements

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
  Little Rock, Arkansas, United States Recruiting
• Neurocrine Clinical Site
  Culver City, California, United States Recruiting
• Neurocrine Clinical Site
  Garden Grove, California, United States Recruiting
• Neurocrine Clinical Site
  Riverside, California, United States Recruiting
• Neurocrine Clinical Site
  Hollywood, Florida, United States Recruiting
• Neurocrine Clinical Site
  North Canton, Ohio, United States Recruiting

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.