Status:
RECRUITING
NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
Lead Sponsor:
Neurocrine Biosciences
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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
- 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
- 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.
- Note: Other protocol-specified inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
May 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT06963034
Start Date
May 8 2025
End Date
October 1 2027
Last Update
December 15 2025
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Neurocrine Clinical Site
Little Rock, Arkansas, United States, 72211
2
Neurocrine Clinical Site
Anaheim, California, United States, 92805
3
Neurocrine Clinical Site
Pico Rivera, California, United States, 90660
4
Neurocrine Clinical Site
San Diego, California, United States, 92123