Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia
NCT ID: NCT05545111
Last Updated: 2025-07-11
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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COMPLETED
PHASE2
210 participants
INTERVENTIONAL
2022-10-04
2024-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dose Level A
Participant administered Dose Level A (6 weeks)
NBI-1117568
Active treatment with orally administered NBI-1117568
Dose Level B
Participant administered Dose Level B (6 weeks)
NBI-1117568
Active treatment with orally administered NBI-1117568
Dose Level C
Participant administered Dose Level C (6 weeks)
NBI-1117568
Active treatment with orally administered NBI-1117568
Dose Level D
Participant administered Dose Level D (6 weeks)
NBI-1117568
Active treatment with orally administered NBI-1117568
Placebo Schedule
Participant administered placebo (6 weeks)
Placebo
Placebo matching NBI-1117568
Interventions
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NBI-1117568
Active treatment with orally administered NBI-1117568
Placebo
Placebo matching NBI-1117568
Eligibility Criteria
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Inclusion Criteria
* Subject has a primary diagnosis of schizophrenia.
* The subject is experiencing an acute exacerbation or relapse of symptoms and currently requires hospitalization.
* Subjects taking prohibited medications, including antipsychotics, must discontinue before study participation
* Subject is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements.
Exclusion Criteria
* Considered by the investigator to be at imminent risk of suicide or injury to self or others.
* Diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening.
* Positive alcohol test or drug screen for disallowed substances.
* Have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the subject is not capable of adhering to the protocol requirements.
18 Years
55 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
Rogers, Arkansas, United States
Neurocrine Clinical Site
Lemon Grove, California, United States
Neurocrine Clinical Site
Pico Rivera, California, United States
Neurocrine Clinical Site
San Diego, California, United States
Neurocrine Clinical Site
Torrance, California, United States
Neurocrine Clinical Site
Miami Lakes, Florida, United States
Neurocrine Clinical Site
Oakland Park, Florida, United States
Neurocrine Clinical Site
Gaithersburg, Maryland, United States
Neurocrine Clinical site
St Louis, Missouri, United States
Neurocrine Clinical Site
Berlin, New Jersey, United States
Neurocrine Clinical Site
North Canton, Ohio, United States
Neurocrine Clinical Site
Austin, Texas, United States
Neurocrine Clinical Site
DeSoto, Texas, United States
Neurocrine Clinical Site
Richardson, Texas, United States
Countries
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Other Identifiers
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NBI-1117568-SCZ2028
Identifier Type: -
Identifier Source: org_study_id
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