NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

Last updated: April 30, 2025
Sponsor: Neurocrine Biosciences
Overall Status: Active - Not Recruiting

Phase

3

Condition

Tourette's Syndrome

Psychosis

Mood Disorders

Treatment

Placebo

NBI-1117568

Clinical Study ID

NCT06963034
NBI-1117568-SCZ3029
  • Ages 18-65
  • All Genders

Study Summary

The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Participant has a primary diagnosis of schizophrenia

  • Participant is experiencing an acute exacerbation or relapse of symptoms andcurrently warrants hospitalization.

  • Participants taking prohibited medications, including antipsychotics, mustdiscontinue before study participation

  • Participant is willing and able to remain in an inpatient setting for the studyduration, follow instructions, and comply with the protocol requirements

Exclusion

Key Exclusion Criteria:

  • Participant has known hypersensitivity to any component of the formulation ofNBI-1117568.

  • Participant has an unstable or poorly controlled medical condition or chronicdisease

  • Participant is considered by the investigator to be at imminent risk of suicide orinjury to self or others

  • Participant has a diagnosis of moderate or severe substance use disorder (with theexception of nicotine or caffeine dependence) within 6 months prior to screening

  • Participant has a positive alcohol test or drug screen for disallowed substances

  • Participants have a history of poor or suspected poor compliance in clinicalresearch studies and/or in the investigator's opinion, the participant is notcapable of adhering to the protocol requirements.

Note: Other protocol-specified inclusion/exclusion criteria may apply.

Study Design

Total Participants: 284
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
May 01, 2025
Estimated Completion Date:
October 31, 2027