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Clinical Trials in the USA / NCT07105098
Recruiting Phase 3

NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

NCT07105098 · tracked via the Priya Life Science USA tracker
Sponsor
Neurocrine Biosciences
Phase
Phase 3
Started
2025-08-11
Last updated
2026-05-15

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

NBI-1117568Placebo

NBI-1117568: NBI-1117568 will be administered per schedule specified in the arm description.

Placebo: Placebo will be administered per schedule specified in the arm description.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Neurocrine Clinical Site Culver City California Recruiting
Neurocrine Clinical Site Garden Grove California Recruiting
Neurocrine Clinical Site Riverside California Recruiting
Neurocrine Clinical Site Atlanta Georgia Recruiting
Neurocrine Clinical Site North Canton Ohio Recruiting
Neurocrine Clinical Site Sliven Bulgaria Recruiting
Neurocrine Clinical Site Veliko Tarnovo Bulgaria Withdrawn
Neurocrine Clinical Site Vratsa Bulgaria Recruiting
Neurocrine Clinical Site Győr Hungary Recruiting
Neurocrine Clinical Site Brasov Romania Recruiting
Neurocrine Clinical Site Brasov Romania Recruiting
Neurocrine Clinical Site Bucharest Romania Recruiting
Neurocrine Clinical Site Belgrade Serbia Recruiting
Neurocrine Clinical Site Gornja Toponica Serbia Recruiting
Neurocrine Clinical Site Kragujevac Serbia Recruiting

More Neurocrine Biosciences trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07105098 on ClinicalTrials.gov ↗ ← All trials in the USA