NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia
NCT ID: NCT07114874
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
800 participants
INTERVENTIONAL
2025-07-11
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NBI-1117568
Participants will receive NBI-1117568 once daily (QD) orally for up to 36 months.
NBI-1117568
NBI-1117568 will be administered per schedule specified in the arm description.
Interventions
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NBI-1117568
NBI-1117568 will be administered per schedule specified in the arm description.
Eligibility Criteria
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Inclusion Criteria
* Participants taking prohibited medications, including antipsychotics, must discontinue before study participation
* Participant must reside in a stable housing situation
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Neurocrine Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Lead
Role: STUDY_DIRECTOR
Neurocrine Biosciences
Locations
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Neurocrine Clinical Site
Little Rock, Arkansas, United States
Neurocrine Clinical Site
Culver City, California, United States
Neurocrine Clinical Site
Garden Grove, California, United States
Neurocrine Clinical Site
Pico Rivera, California, United States
Neurocrine Clinical Site
Riverside, California, United States
Neurocrine Clinical Site
San Diego, California, United States
Neurocrine Clinical Site
Sherman, California, United States
Neurocrine Clinical Site
Torrance, California, United States
Neurocrine Clinical Site
Hollywood, Florida, United States
Neurocrine Clinical Site
Miami Lakes, Florida, United States
Neurocrine Clinical Site
Atlanta, Georgia, United States
Neurocrine Clinical Site
Atlanta, Georgia, United States
Neurocrine Clinical Site
Decatur, Georgia, United States
Neurocrine Clinical Sites
Peachtree Corners, Georgia, United States
Neurocrine Clinical Site
Chicago, Illinois, United States
Neurocrine Clinical Site
Gaithersburg, Maryland, United States
Neurocrine Clinical Site
Watertown, Massachusetts, United States
Neurocrine Clinical Site
St Louis, Missouri, United States
Neurocrine Clinical Site
Marlton, New Jersey, United States
Neurocrine Clincial Site
Staten Island, New York, United States
Neurocrine Clinical Sites
The Bronx, New York, United States
Neurocrine Clinical Sites
North Canton, Ohio, United States
Neurocrine Clinical Site
Austin, Texas, United States
Neurocrine Clinical Sites
Orem, Utah, United States
Countries
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Central Contacts
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Other Identifiers
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2025-521216-19-00
Identifier Type: CTIS
Identifier Source: secondary_id
NBI-1117568-SCZ3032
Identifier Type: -
Identifier Source: org_study_id
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