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
- Schizophrenia
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Neurocrine Biosciences
- Enrolment target
- 284
- Started
- 11 August 2025
- Main results due
- November 2027
- Study sites
- 20
- Registry updated
- 25 September 2026
Can you take part?
- Ages 18 years to 65 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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 this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(20)
Neurocrine Clinical Site
Little Rock, Arkansas, United States
Recruiting
Neurocrine Clinical Site
Culver City, California, United States
Recruiting
Neurocrine Clinical Site
Garden Grove, California, United States
Recruiting
Neurocrine Clinical Site
Riverside, California, United States
Recruiting
Neurocrine Clinical Site
Hollywood, Florida, United States
Recruiting
Neurocrine Clinical Site
Atlanta, Georgia, United States
Completed
Neurocrine Clinical Site
North Canton, Ohio, United States
Recruiting
Neurocrine Clinical Site
Pleven, Bulgaria
Recruiting
Neurocrine Clinical Site
Sliven, Bulgaria
Recruiting
Neurocrine Clinical Site
Veliko Tarnovo, Bulgaria
Withdrawn
Neurocrine Clinical Site
Vratsa, Bulgaria
Recruiting
Neurocrine Clinical Site
Budapest, Hungary
Recruiting
Neurocrine Clinical Site
Gyöngyös, Hungary
Recruiting
Neurocrine Clinical Site
Győr, Hungary
Completed
Neurocrine Clinical Site
Brasov, Romania
Recruiting
Neurocrine Clinical Site
Brasov, Romania
Recruiting
Neurocrine Clinical Site
Bucharest, Romania
Completed
Neurocrine Clinical Site
Belgrade, Serbia
Withdrawn
Neurocrine Clinical Site
Gornja Toponica, Serbia
Recruiting
Neurocrine Clinical Site
Kragujevac, Serbia
Recruiting
Showing 20 of 20 sites. 15 of the 20 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07105098. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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