NCT07105098PHASE3Recruiting
NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
Neurocrine Biosciences
Start Date
8/11/2025
Completion Date
11/1/2027
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
Age Range: 18 years to 65 years
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.
Interventions
DRUG
NBI-1117568
DRUG
Placebo
Conditions
Schizophrenia
Locations
Neurocrine Clinical Site
Culver City, California 90230
United States
Neurocrine Clinical Site
Garden Grove, California 92845
United States
Neurocrine Clinical Site
Riverside, California 92506
United States
Neurocrine Clinical Site
Atlanta, Georgia 30328
United States
Neurocrine Clinical Site
North Canton, Ohio 44720
United States
Neurocrine Clinical Site
Sliven, 8800
Bulgaria
Neurocrine Clinical Site
Veliko Tarnovo, 5047
Bulgaria
Neurocrine Clinical Site
Vratsa, 3001
Bulgaria
Neurocrine Clinical Site
Győr, 9024
Hungary
Neurocrine Clinical Site
Brasov, 500123
Romania
Neurocrine Clinical Site
Brasov, 507190
Romania
Neurocrine Clinical Site
Bucharest, 41914
Romania
Neurocrine Clinical Site
Belgrade, 11000
Serbia
Neurocrine Clinical Site
Gornja Toponica, 18202
Serbia
Neurocrine Clinical Site
Kragujevac, 34000
Serbia