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RECRUITING

NCT06706674

PHASE3

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

Sponsor: Intra-Cellular Therapies, Inc.

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

5 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2024-12-06

Completion Date

2027-06-21

Last Updated

2026-07-07

Healthy Volunteers

Conditions

Irritability Associated With Autism Spectrum Disorder

Interventions

DRUG

Lumateperone high dose

Lumateperone administered orally once daily

DRUG

Lumateperone low dose

Lumateperone administered orally once daily

DRUG

Placebo

Matching Placebo administered orally once daily

Inclusion Criteria: 1. All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patient's condition, and accompany the patient to study visits. 2. Able to provide consent as follows: 1. The patient's LAR must provide written, informed consent. 2. When developmentally appropriate based on Investigator judgment, the patient should provide written assent. 3. Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment. 4. Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL); 5. ABC-I subscale score of \>18 at Screening and Baseline; 6. CGI-S score \> 4 with respect to irritability associated with ASD at Screening and Baseline. Exclusion Criteria: 1. Has a primary psychiatric diagnosis other than ASD. Exceptions include: 1. Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records. 2. Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded). 2. History or current diagnosis of Rett syndrome or Fragile X syndrome; 3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or 1. At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (CSSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit; 2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or 3. The patient is considered to be an imminent danger to themselves or others.

Locations (38)

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

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

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (38)