RECRUITINGPhase 3INTERVENTIONAL
NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
A Global, Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
About This Trial
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 May Be Eligible (Plain English)
Key Who May Qualify:
- 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 Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
NBI-1117568
NBI-1117568 will be administered per schedule specified in the arm description.
DRUG
Placebo
Placebo will be administered per schedule specified in the arm description.
Locations (5)
Neurocrine Clinical Site
Culver City, California, United States
Neurocrine Clinical Site
Garden Grove, California, United States
Neurocrine Clinical Site
Riverside, California, United States
Neurocrine Clinical Site
Atlanta, Georgia, United States
Neurocrine Clinical Site
North Canton, Ohio, United States