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Clinical Trials in the USA / NCT06963034
Recruiting Phase 3

NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

NCT06963034 · tracked via the Priya Life Science USA tracker
Sponsor
Neurocrine Biosciences
Phase
Phase 3
Started
2025-05-08
Last updated
2026-03-06

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 * 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.

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
Neurocrine Clinical Site Bryant Arkansas Recruiting
Neurocrine Clinical Site Little Rock Arkansas Recruiting
Neurocrine Clinical Site Anaheim California Recruiting
Neurocrine Clinical Site Pico Rivera California Recruiting
Neurocrine Clinical Site San Diego California Recruiting
Neurocrine Clinical Site Sherman Oaks California Recruiting
Neurocrine Clinical Site Torrance California Recruiting
Neurocrine Clinical Site Hollywood Florida Recruiting
Neurocrine Clinical Site Miami Lakes Florida Recruiting
Neurocrine Clinical Site Atlanta Georgia Recruiting
Neurocrine Clinical Site Decatur Georgia Recruiting
Neurocrine Clinical Site Snellville Georgia Recruiting
Neurocrine Clinical Site Chicago Illinois Recruiting
Neurocrine Clinical Site Gaithersburg Maryland Recruiting
Neurocrine Clinical Site Watertown Massachusetts Recruiting
Neurocrine Clinical Site Marlton New Jersey Recruiting
Neurocrine Clinical Site Staten Island New York Recruiting
Neurocrine Clinical Site The Bronx New York Recruiting
Neurocrine Clinical Site Austin Texas Recruiting
Neurocrine Clinical Site DeSoto Texas Recruiting
Neurocrine Clinical Site Houston Texas 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 NCT06963034 on ClinicalTrials.gov ↗ ← All trials in the USA