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OpenTrials
Completed

NCT Number: NCT05545111

Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, multi-arm, multi-stage inpatient study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of NBI-1117568 compared with placebo in adult subjects with a primary diagnosis of schizophrenia, who are experiencing an acute exacerbation or relapse of symptoms.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Neurocrine Clinical Site, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Completed informed consent.
  • 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.

Key Exclusion Criteria:

  • An unstable medical condition, chronic disease, or malignancy.
  • 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.

Treatment and study plan

NBI-1117568

Drug

Active treatment with orally administered NBI-1117568

Placebo

Drug

Placebo matching NBI-1117568

Primary outcomes

  1. Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6

    Time frame: Baseline and Week 6

    The PANSS evaluates the severity of various symptoms of schizophrenia, and is commonly used to measure symptom reduction in patients taking antipsychotics. Each item is scored on a 7-point severity scale (1=absent; 2=minimal; 3=mild; 4=moderate; 5=moderate severe; 6=severe; 7=extreme). The PANSS total score is derived from the summation of each item. A higher score indicates greater severity.

Sponsors and collaborators

Lead sponsor

Neurocrine Biosciences

Industry

Registry information

Official study title

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2022
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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