RecruitingPhase 3NCT06963034

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

A 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

May 8, 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 study is testing a new medication called NBI-1117568 for people with schizophrenia who are experiencing an acute episode (a relapse or worsening of symptoms) serious enough to require hospitalization. The goal is to assess whether this drug is effective and safe for treating active schizophrenia symptoms in an inpatient setting. **You may be eligible if...** - You have been diagnosed with schizophrenia - You are currently experiencing a relapse or worsening of symptoms and need to be hospitalized - You are willing and able to remain in an inpatient setting for the duration of the study - You are willing to stop other antipsychotic medications before participating **You may NOT be eligible if...** - You have a known allergy to any ingredient in NBI-1117568 - You have an unstable or poorly controlled medical condition or serious chronic illness - You are considered to be at risk of harming yourself or others - You have had moderate to severe substance use disorder (other than nicotine or caffeine) within the past 6 months - You tested positive for alcohol or other prohibited drugs at screening - You have a history of not following research protocols 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(21)

Neurocrine Clinical Site

Bryant, Arkansas, United States

Neurocrine Clinical Site

Little Rock, Arkansas, United States

Neurocrine Clinical Site

Anaheim, California, United States

Neurocrine Clinical Site

Pico Rivera, California, United States

Neurocrine Clinical Site

San Diego, California, United States

Neurocrine Clinical Site

Sherman Oaks, California, United States

Neurocrine Clinical Site

Torrance, California, United States

Neurocrine Clinical Site

Hollywood, Florida, United States

Neurocrine Clinical Site

Miami Lakes, Florida, United States

Neurocrine Clinical Site

Atlanta, Georgia, United States

Neurocrine Clinical Site

Decatur, Georgia, United States

Neurocrine Clinical Site

Snellville, Georgia, United States

Neurocrine Clinical Site

Chicago, Illinois, United States

Neurocrine Clinical Site

Gaithersburg, Maryland, United States

Neurocrine Clinical Site

Watertown, Massachusetts, United States

Neurocrine Clinical Site

Marlton, New Jersey, United States

Neurocrine Clinical Site

Staten Island, New York, United States

Neurocrine Clinical Site

The Bronx, New York, United States

Neurocrine Clinical Site

Austin, Texas, United States

Neurocrine Clinical Site

DeSoto, Texas, United States

Neurocrine Clinical Site

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06963034


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