Recruiting

Phase 3

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

Sponsor:

Neurocrine Biosciences

Code:

NCT07114874

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

NBI-1117568

Study Details

Brief summary:

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

Conditions

Schizophrenia

Study ID

NCT07114874

Start date

Jul 11, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NBI-1117568

Participants will receive NBI-1117568 once daily (QD) orally for up to 36 months.

Interventions

NBI-1117568

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

Primary outcome measure

Number of Participants with Treatment-emergent Adverse Events [ Time Frame: Up to 36 months ]

Central Contacts and Locations

Central contacts

Neurocrine Medical Information Call Center

877-641-3461 medinfo@neurocrine.com

Locations

Neurocrine Clinical Site

Recruiting

Bryant, Arkansas, United States, 72022

Neurocrine Clinical Site

Recruiting

Little Rock, Arkansas, United States, 72211

Neurocrine Clinical Site

Recruiting

Cerritos, California, United States, 90703

Neurocrine Clinical Site

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Chino, California, United States, 91710

Neurocrine Clinical Site

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Culver City, California, United States, 90230

Neurocrine Clinical Site

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Garden Grove, California, United States, 92845

Neurocrine Clinical Site

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La Habra, California, United States, 90631

Neurocrine Clinical Site

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Lemon Grove, California, United States, 91945

Neurocrine Clinical Site

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Oceanside, California, United States, 92056

Neurocrine Clinical Site

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Pico Rivera, California, United States, 90660

Neurocrine Clinical Site

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Riverside, California, United States, 92506

Neurocrine Clinical Site

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San Diego, California, United States, 92123

Neurocrine Clinical Site

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Sherman, California, United States, 91403

Neurocrine Clinical Site

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Torrance, California, United States, 90504

Neurocrine Clinical Site

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West Hills, California, United States, 91307

Neurocrine Clinical Site

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Atlantis, Florida, United States, 30328

Neurocrine Clinical Site

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Aventura, Florida, United States, 33108

Neurocrine Clinical Site

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Doral, Florida, United States, 33178

Neurocrine Clinical Site

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Hollywood, Florida, United States, 33024

Neurocrine Clinical Site

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Maitland, Florida, United States, 32751

Neurocrine Clinical Site

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Miami, Florida, United States, 33122

Neurocrine Clinical Site

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Miami, Florida, United States, 33155

Neurocrine Clinical Site

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Miami Lakes, Florida, United States, 33016

Neurocrine Clinical Site

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Tampa, Florida, United States, 33629

Neurocrine Clinical Site

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West Palm Beach, Florida, United States, 33407

Neurocrine Clinical Site

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Atlanta, Georgia, United States, 30328

Neurocrine Clinical Site

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Atlanta, Georgia, United States, 30331

Neurocrine Clinical Site

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Decatur, Georgia, United States, 30030

Neurocrine Clinical Sites

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Peachtree Corners, Georgia, United States, 30071

Neurocrine Clinical Site

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Chicago, Illinois, United States, 60640

Neurocrine Clinical Site

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Gaithersburg, Maryland, United States, 20877

Neurocrine Clinical Site

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Boston, Massachusetts, United States, 02116

Neurocrine Clinical Site

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Watertown, Massachusetts, United States, 02472

Neurocrine Clinical Site

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Flowood, Mississippi, United States, 39232

Neurocrine Clinical Site

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St Louis, Missouri, United States, 63141

Neurocrine Clinical Site

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Marlton, New Jersey, United States, 08053

Neurocrine Clinical Site

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Cedarhurst, New York, United States, 11516

Neurocrine Clinical Site

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New York, New York, United States, 10029

Neurocrine Clinical Site

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New York, New York, United States, 10036

Neurocrine Clincial Site

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Staten Island, New York, United States, 10314

Neurocrine Clinical Sites

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The Bronx, New York, United States, 10461

Neurocrine Clinical Sites

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North Canton, Ohio, United States, 44720

Neurocrine Clinical Site

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Philadelphia, Pennsylvania, United States, 19104

Neurocrine Clinical Site

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Austin, Texas, United States, 78754

Neurocrine Clinical Site

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DeSoto, Texas, United States, 75115

Neurocrine Clinical Site

Recruiting

Houston, Texas, United States, 77043

Neurocrine Clinical Sites

Recruiting

Orem, Utah, United States, 84058

Neurocrine Clinical Site

Recruiting

Orem, Utah, United States, 84058

Neurocrine Clinical Site

Recruiting

Bellevue, Washington, United States, 98007

More Information

Sponsor

Neurocrine Biosciences

Last update posted

Jun 5, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Neurocrine Biosciences on 2026-06-05.