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NCT06963034PHASE3Recruiting

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

Neurocrine Biosciences

Start Date

5/8/2025

Completion Date

10/1/2027

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

Age Range: 18 years to 65 years

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.

Interventions

DRUG

NBI-1117568

DRUG

Placebo

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Conditions

Schizophrenia

Locations

Neurocrine Clinical Site

Bryant, Arkansas 72022

United States

Neurocrine Clinical Site

Little Rock, Arkansas 72211

United States

Neurocrine Clinical Site

Anaheim, California 92805

United States

Neurocrine Clinical Site

Pico Rivera, California 90660

United States

Neurocrine Clinical Site

San Diego, California 92123

United States

Neurocrine Clinical Site

Sherman Oaks, California 91403

United States

Neurocrine Clinical Site

Torrance, California 90504

United States

Neurocrine Clinical Site

Hollywood, Florida 33024

United States

Neurocrine Clinical Site

Miami Lakes, Florida 33016

United States

Neurocrine Clinical Site

Atlanta, Georgia 30331

United States

Neurocrine Clinical Site

Decatur, Georgia 30030

United States

Neurocrine Clinical Site

Snellville, Georgia 30078

United States

Neurocrine Clinical Site

Chicago, Illinois 60640

United States

Neurocrine Clinical Site

Gaithersburg, Maryland 20877

United States

Neurocrine Clinical Site

Watertown, Massachusetts 02472

United States

Neurocrine Clinical Site

Marlton, New Jersey 08053

United States

Neurocrine Clinical Site

Staten Island, New York 10314

United States

Neurocrine Clinical Site

The Bronx, New York 10461

United States

Neurocrine Clinical Site

Austin, Texas 78754

United States

Neurocrine Clinical Site

DeSoto, Texas 75115

United States

Neurocrine Clinical Site

Houston, Texas 77043

United States