RecruitingPhase 3NCT06706674

Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age

Sponsor

Intra-Cellular Therapies, Inc.

Enrollment

160 participants

Start Date

Dec 6, 2024

Study Type

INTERVENTIONAL

Conditions

Irritability Associated With Autism Spectrum Disorder

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).

Eligibility

Min Age: 5 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Lumateperone high dose, a drug called Lumateperone low dose, and others for people with irritability associated with autism spectrum disorder. The study is currently recruiting participants at 39 locations. People eligible for this study include aged 5 Years to 17 Years.

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

DRUGLumateperone high dose

Lumateperone administered orally once daily

DRUGLumateperone low dose

Lumateperone administered orally once daily

DRUGPlacebo

Matching Placebo administered orally once daily

Locations(40)

Pillar Clinical Research, LLC

Little Rock, Arkansas, United States

University Of California - Davis

Sacramento, California, United States

California Neuroscience Research

Sherman Oaks, California, United States

Yale University School Of Medicine

New Haven, Connecticut, United States

United Research Institute

Hialeah, Florida, United States

Advanced Research Institute of Miami

Homestead, Florida, United States

Vital Care Research

Miami, Florida, United States

Care Research Center Inc

Miami, Florida, United States

Blue Medical Research

Miami, Florida, United States

AP Medical Research

Miami, Florida, United States

GTL Medical and Research Group

Miami, Florida, United States

New Med Research Inc

Miami Gardens, Florida, United States

Riveldi Biomedical Research

Miami Lakes, Florida, United States

APG Research LLC

Orlando, Florida, United States

Orlando Psychiatric Associates

Orlando, Florida, United States

Clinical Research Center of Florida

Pompano Beach, Florida, United States

University of South Florida Rothman Center of Neuropsychiatry

St. Petersburg, Florida, United States

Advanced Discovery Research

Atlanta, Georgia, United States

Salveo Integrative Health Inc

Lawrenceville, Georgia, United States

EmVenio Research at Chicago

Chicago, Illinois, United States

Baber Research Group

Naperville, Illinois, United States

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States

Louisiana State University Health Sciences Center Shreveport

Shreveport, Louisiana, United States

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, United States

Alivation Research LLC

Lincoln, Nebraska, United States

NYU Child Study Center

New York, New York, United States

Nathan Kline Institute

Orangeburg, New York, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Advantage Clinical Trials

The Bronx, New York, United States

Quest Therapeutics of Avon Lake

Avon Lake, Ohio, United States

SP Research, PLLC (dba Rivus Wellness & Research Institute)

Oklahoma City, Oklahoma, United States

Sooner Clinical Research

Oklahoma City, Oklahoma, United States

Medical University of South Carolina

Charleston, South Carolina, United States

BioBehavioral Research of Austin PC

Austin, Texas, United States

Texas Research Group

Coppell, Texas, United States

Future Search Trials of Dallas

Dallas, Texas, United States

North Texas Clinical Trials

Fort Worth, Texas, United States

Red Oak Psychiatry Associates

Houston, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Core Clinical Research

Everett, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06706674

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