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

Last updated: March 5, 2026
Sponsor: Neurocrine Biosciences
Overall Status: Active - Recruiting

Phase

3

Condition

Psychosis

Mood Disorders

Tourette's Syndrome

Treatment

Placebo

NBI-1117568

Clinical Study ID

NCT06963034
NBI-1117568-SCZ3029
  • Ages 18-65
  • All Genders

Study 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

Inclusion

Key Inclusion Criteria:

  • Participant has a primary diagnosis of schizophrenia

  • Participant is experiencing an acute exacerbation or relapse of symptoms andcurrently warrants hospitalization.

  • Participants taking prohibited medications, including antipsychotics, mustdiscontinue before study participation

  • Participant is willing and able to remain in an inpatient setting for the studyduration, follow instructions, and comply with the protocol requirements

Exclusion

Key Exclusion Criteria:

  • Participant has known hypersensitivity to any component of the formulation ofNBI-1117568.

  • Participant has an unstable or poorly controlled medical condition or chronicdisease

  • Participant is considered by the investigator to be at imminent risk of suicide orinjury to self or others

  • Participant has a diagnosis of moderate or severe substance use disorder (with theexception 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 clinicalresearch studies and/or in the investigator's opinion, the participant is notcapable of adhering to the protocol requirements.

Note: Other protocol-specified inclusion/exclusion criteria may apply.

Study Design

Total Participants: 284
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
May 08, 2025
Estimated Completion Date:
October 31, 2027

Connect with a study center

  • Neurocrine Clinical Site

    Bryant, Arkansas 72022
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Little Rock, Arkansas 72211
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Little Rock 4119403, Arkansas 4099753 72211
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Anaheim, California 92805
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Pico Rivera, California 90660
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    San Diego, California 92123
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Sherman Oaks, California 91403
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Torrance, California 90504
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Anaheim 5323810, California 5332921 92805
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Pico Rivera 5382496, California 5332921 90660
    United States

    Site Not Available

  • Neurocrine Clinical Site

    San Diego 5391811, California 5332921 92123
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Sherman Oaks 5395244, California 5332921 91403
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Torrance 5403022, California 5332921 90504
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Hollywood 4158928, Florida 4155751 33024
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Miami Lakes 4164186, Florida 4155751 33016
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Atlanta, Georgia 30331
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Snellville, Georgia 30078
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Atlanta 4180439, Georgia 4197000 30331
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Decatur 4191124, Georgia 4197000 30030
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Peachtree Corners 4215114, Georgia 4197000 30071
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Chicago, Illinois 60640
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Chicago 4887398, Illinois 4896861 60640
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Gaithersburg, Maryland 20877
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Gaithersburg 4355843, Maryland 4361885 20877
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Watertown, Massachusetts 02472
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Watertown 4954611, Massachusetts 6254926 02472
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Marlton, New Jersey 08053
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Marlton 4502911, New Jersey 5101760 08053
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Staten Island, New York 10314
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    The Bronx, New York 10461
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Staten Island 5139568, New York 5128638 10314
    United States

    Site Not Available

  • Neurocrine Clinical Site

    The Bronx 5110266, New York 5128638 10461
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Austin, Texas 78754
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    DeSoto, Texas 75115
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Houston, Texas 77043
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Austin 4671654, Texas 4736286 78754
    United States

    Site Not Available

  • Neurocrine Clinical Site

    DeSoto 4685524, Texas 4736286 75115
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Houston 4699066, Texas 4736286 77043
    United States

    Site Not Available

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