NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia (NCT07105098) | Clinical Trial Compass
RecruitingPhase 3
NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
United States284 participantsStarted 2025-08-11
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5