RecruitingPhase 3NCT07114874

NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia

A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia

Sponsor

Neurocrine Biosciences

Enrollment

800 participants

Start Date

Jul 11, 2025

Study Type

INTERVENTIONAL

Conditions

Schizophrenia

Summary

This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This long-term study is evaluating the safety and effectiveness of an experimental drug called NBI-1117568 in adults with schizophrenia. The drug works differently from traditional antipsychotics by targeting a specific brain receptor (muscarinic M4). **You may be eligible if...** - You have a primary diagnosis of schizophrenia - You have stable housing - You are willing to stop taking antipsychotic medications before entering the study (as instructed by the study team) **You may NOT be eligible if...** - You have a known allergy to any ingredient in NBI-1117568 - You have an unstable or poorly controlled physical health condition - You are considered at imminent risk of harming yourself or others - You have moderate or severe substance use disorder (other than nicotine or caffeine) within the past 6 months - You have a history of not following research study requirements 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.

Locations(53)

Neurocrine Clinical Site

Bryant, Arkansas, United States

Neurocrine Clinical Site

Little Rock, Arkansas, United States

Neurocrine Clinical Site

Chino, California, United States

Neurocrine Clinical Site

Culver City, California, United States

Neurocrine Clinical Site

Garden Grove, California, United States

Neurocrine Clinical Site

La Habra, California, United States

Neurocrine Clinical Site

Lemon Grove, California, United States

Neurocrine Clinical Site

Oceanside, California, United States

Neurocrine Clinical Site

Pico Rivera, California, United States

Neurocrine Clinical Site

Riverside, California, United States

Neurocrine Clinical Site

San Diego, California, United States

Neurocrine Clinical Site

Sherman, California, United States

Neurocrine Clinical Site

Torrance, California, United States

Neurocrine Clinical Site

West Hills, California, United States

Neurocrine Clinical Site

Atlantis, Florida, United States

Neurocrine Clinical Site

Aventura, Florida, United States

Neurocrine Clinical Site

Doral, Florida, United States

Neurocrine Clinical Site

Hollywood, Florida, United States

Neurocrine Clinical Site

Maitland, Florida, United States

Neurocrine Clinical Site

Miami, Florida, United States

Neurocrine Clinical Site

Miami Lakes, Florida, United States

Neurocrine Clinical Site

Tampa, Florida, United States

Neurocrine Clinical Site

West Palm Beach, Florida, United States

Neurocrine Clinical Site

Atlanta, Georgia, United States

Neurocrine Clinical Site

Atlanta, Georgia, United States

Neurocrine Clinical Site

Decatur, Georgia, United States

Neurocrine Clinical Sites

Peachtree Corners, Georgia, United States

Neurocrine Clinical Site

Chicago, Illinois, United States

Neurocrine Clinical Site

Gaithersburg, Maryland, United States

Neurocrine Clinical Site

Boston, Massachusetts, United States

Neurocrine Clinical Site

Watertown, Massachusetts, United States

Neurocrine Clinical Site

Flowood, Mississippi, United States

Neurocrine Clinical Site

St Louis, Missouri, United States

Neurocrine Clinical Site

Marlton, New Jersey, United States

Neurocrine Clinical Site

Cedarhurst, New York, United States

Neurocrine Clinical Site

New York, New York, United States

Neurocrine Clinical Site

New York, New York, United States

Neurocrine Clincial Site

Staten Island, New York, United States

Neurocrine Clinical Sites

The Bronx, New York, United States

Neurocrine Clinical Sites

North Canton, Ohio, United States

Neurocrine Clinical Site

Philadelphia, Pennsylvania, United States

Neurocrine Clinical Site

Austin, Texas, United States

Neurocrine Clinical Site

DeSoto, Texas, United States

Neurocrine Clinical Site

Houston, Texas, United States

Neurocrine Clinical Sites

Orem, Utah, United States

Neurocrine Clinical Site

Orem, Utah, United States

Neurocrine Clinical Site

Bellevue, Washington, United States

Neurocrine Clinical Site

Veliko Tarnovo, Bulgaria

Neurocrine Clinical Site

Vratsa, Bulgaria

Neurocrine Clinical Site

Brasov, Romania

Neurocrine Clinical Site

Bucharest, Romania

Neurocrine Clinical Site

Sânpetru, Romania

Neurocrine Clinical Site

Belgrade, Serbia

View Full Details on ClinicalTrials.gov

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NCT07114874

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