RecruitingPhase 3NCT06963034
NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
A 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
Sponsor
Neurocrine Biosciences
Enrollment
284 participants
Start Date
May 8, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria4
- 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
Exclusion Criteria6
- 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
- Participants have 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.
Interventions
DRUGNBI-1117568
NBI-1117568 will be administered per schedule specified in the arm description.
DRUGPlacebo
Placebo will be administered per schedule specified in the arm description.
Locations(21)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06963034
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