RecruitingPhase 3NCT07105098

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


Sponsor

Neurocrine Biosciences

Enrollment

284 participants

Start Date

Aug 11, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This inpatient study is testing a new drug called NBI-1117568 to see if it can safely and effectively reduce acute symptoms in people with schizophrenia who are currently hospitalized during a relapse or flare-up. **You may be eligible if...** - You have a primary diagnosis of schizophrenia - You are currently in the hospital due to worsening symptoms - You are willing to stay in the hospital for the duration of the study and follow the protocol - You are willing to stop taking antipsychotic medications before starting the study drug **You may NOT be eligible if...** - You have a known allergy to NBI-1117568 or its ingredients - You have unstable or serious medical conditions unrelated to schizophrenia - You are considered at imminent risk of harming yourself or others - You have certain other psychiatric or neurological diagnoses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNBI-1117568

NBI-1117568 will be administered per schedule specified in the arm description.

DRUGPlacebo

Placebo will be administered per schedule specified in the arm description.


Locations(11)

Neurocrine Clinical Site

Culver City, California, United States

Neurocrine Clinical Site

Garden Grove, California, United States

Neurocrine Clinical Site

Riverside, California, United States

Neurocrine Clinical Site

Atlanta, Georgia, United States

Neurocrine Clinical Site

North Canton, Ohio, United States

Neurocrine Clinical Site

Sliven, Bulgaria

Neurocrine Clinical Site

Veliko Tarnovo, Bulgaria

Neurocrine Clinical Site

Vratsa, Bulgaria

Neurocrine Clinical Site

Brasov, Romania

Neurocrine Clinical Site

Brasov, Romania

Neurocrine Clinical Site

Bucharest, Romania

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07105098


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