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NCT07105098From ClinicalTrials.govRecruiting

NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

A Global, Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization

  • Schizophrenia

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Neurocrine Biosciences
Enrolment target
284
Started
11 August 2025
Main results due
November 2027
Study sites
20
Registry updated
25 September 2026

Can you take part?

  • Ages 18 years to 65 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Key Inclusion Criteria:

* Participant has a primary diagnosis of schizophrenia
* Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization.
* Participants taking prohibited medications, including antipsychotics, must discontinue before study participation
* Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements

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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(20)

  • Neurocrine Clinical Site

    Little Rock, Arkansas, United States

    Recruiting

  • Neurocrine Clinical Site

    Culver City, California, United States

    Recruiting

  • Neurocrine Clinical Site

    Garden Grove, California, United States

    Recruiting

  • Neurocrine Clinical Site

    Riverside, California, United States

    Recruiting

  • Neurocrine Clinical Site

    Hollywood, Florida, United States

    Recruiting

  • Neurocrine Clinical Site

    Atlanta, Georgia, United States

    Completed

  • Neurocrine Clinical Site

    North Canton, Ohio, United States

    Recruiting

  • Neurocrine Clinical Site

    Pleven, Bulgaria

    Recruiting

  • Neurocrine Clinical Site

    Sliven, Bulgaria

    Recruiting

  • Neurocrine Clinical Site

    Veliko Tarnovo, Bulgaria

    Withdrawn

  • Neurocrine Clinical Site

    Vratsa, Bulgaria

    Recruiting

  • Neurocrine Clinical Site

    Budapest, Hungary

    Recruiting

  • Neurocrine Clinical Site

    Gyöngyös, Hungary

    Recruiting

  • Neurocrine Clinical Site

    Győr, Hungary

    Completed

  • Neurocrine Clinical Site

    Brasov, Romania

    Recruiting

  • Neurocrine Clinical Site

    Brasov, Romania

    Recruiting

  • Neurocrine Clinical Site

    Bucharest, Romania

    Completed

  • Neurocrine Clinical Site

    Belgrade, Serbia

    Withdrawn

  • Neurocrine Clinical Site

    Gornja Toponica, Serbia

    Recruiting

  • Neurocrine Clinical Site

    Kragujevac, Serbia

    Recruiting

Showing 20 of 20 sites. 15 of the 20 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07105098. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia | Trialion