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NCT07114874PHASE3Recruiting

NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia

Neurocrine Biosciences

Start Date

7/11/2025

Completion Date

12/1/2031

Summary

This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.

Eligibility Criteria

Age Range: 18 years to 65 years

Key Inclusion Criteria: * Participant has a primary diagnosis of schizophrenia * Participants taking prohibited medications, including antipsychotics, must discontinue before study participation * Participant must reside in a stable housing situation 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.

Interventions

DRUG

NBI-1117568

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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

Cerritos, California 90703

United States

Neurocrine Clinical Site

Chino, California 91710

United States

Neurocrine Clinical Site

Culver City, California 90230

United States

Neurocrine Clinical Site

Garden Grove, California 92845

United States

Neurocrine Clinical Site

La Habra, California 90631

United States

Neurocrine Clinical Site

Lemon Grove, California 91945

United States

Neurocrine Clinical Site

Oceanside, California 92056

United States

Neurocrine Clinical Site

Pico Rivera, California 90660

United States

Neurocrine Clinical Site

Riverside, California 92506

United States

Neurocrine Clinical Site

San Diego, California 92123

United States

Neurocrine Clinical Site

Sherman, California 91403

United States

Neurocrine Clinical Site

Torrance, California 90504

United States

Neurocrine Clinical Site

West Hills, California 91307

United States

Neurocrine Clinical Site

Atlantis, Florida 30328

United States

Neurocrine Clinical Site

Aventura, Florida 33108

United States

Neurocrine Clinical Site

Doral, Florida 33178

United States

Neurocrine Clinical Site

Hollywood, Florida 33024

United States

Neurocrine Clinical Site

Maitland, Florida 32751

United States

Neurocrine Clinical Site

Miami, Florida 33122

United States

Neurocrine Clinical Site

Miami, Florida 33155

United States

Neurocrine Clinical Site

Miami Lakes, Florida 33016

United States

Neurocrine Clinical Site

Tampa, Florida 33629

United States

Neurocrine Clinical Site

West Palm Beach, Florida 33407

United States

Neurocrine Clinical Site

Atlanta, Georgia 30328

United States

Neurocrine Clinical Site

Atlanta, Georgia 30331

United States

Neurocrine Clinical Site

Decatur, Georgia 30030

United States

Neurocrine Clinical Sites

Peachtree Corners, Georgia 30071

United States

Neurocrine Clinical Site

Chicago, Illinois 60640

United States

Neurocrine Clinical Site

Gaithersburg, Maryland 20877

United States

Neurocrine Clinical Site

Boston, Massachusetts 02116

United States

Neurocrine Clinical Site

Watertown, Massachusetts 02472

United States

Neurocrine Clinical Site

Flowood, Mississippi 39232

United States

Neurocrine Clinical Site

St Louis, Missouri 63141

United States

Neurocrine Clinical Site

Marlton, New Jersey 08053

United States

Neurocrine Clinical Site

Cedarhurst, New York 11516

United States

Neurocrine Clinical Site

New York, New York 10029

United States

Neurocrine Clinical Site

New York, New York 10036

United States

Neurocrine Clincial Site

Staten Island, New York 10314

United States

Neurocrine Clinical Sites

The Bronx, New York 10461

United States

Neurocrine Clinical Sites

North Canton, Ohio 44720

United States

Neurocrine Clinical Site

Philadelphia, Pennsylvania 19104

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

Neurocrine Clinical Sites

Orem, Utah 84058

United States

Neurocrine Clinical Site

Orem, Utah 84058

United States

Neurocrine Clinical Site

Bellevue, Washington 98007

United States

Neurocrine Clinical Site

Veliko Tarnovo, 5047

Bulgaria

Neurocrine Clinical Site

Vratsa, 5047

Bulgaria

Neurocrine Clinical Site

Brasov, 500123

Romania

Neurocrine Clinical Site

Bucharest, 41914

Romania

Neurocrine Clinical Site

Sânpetru, 507190

Romania

Neurocrine Clinical Site

Belgrade, 11000

Serbia

Neurocrine Clinical Site

Gornja Toponica, 18202

Serbia

Neurocrine Clinical Site

Kragujevac, 34000

Serbia