RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Intra-Cellular Therapies, Inc. • ClinicalTrials.gov ID: NCT06690398

Registry updated: 2026-09-25

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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).

Interventions

Lumateperone high dose (Drug)
Lumateperone administered orally once daily
Lumateperone low dose (Drug)
Lumateperone administered orally once daily
Placebo (Drug)
Matching Placebo administered orally once daily

Eligibility criteria

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 (C-SSRS) 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.

Conditions

Irritability Associated With Autism Spectrum Disorder

Locations

Harmonex Neuroscience Research — Dothan, Alabama, United States
Southwest Autism Research and Resource Center — Phoenix, Arizona, United States
Advanced Research Center Inc — Anaheim, California, United States
Excell Research Inc — Oceanside, California, United States
Inland Psychiatric Medical Group Inc — Redlands, California, United States
Buena Park Research — Upland, California, United States
Next Level Clinical Trials, LLC — West Covina, California, United States
MCB Clinical Research Centers LLC — Colorado Springs, Colorado, United States
Royal Palm Clinical Research — Fort Myers, Florida, United States
Sarkis Clinical Trials — Gainesville, Florida, United States
Green Leaf Clinical Trials — Jacksonville, Florida, United States
Columbus Clinical Services LLC — Miami, Florida, United States
South Florida Research Phase I-IV — Miami, Florida, United States
Diverse Clinical Research LLC — Miami, Florida, United States
Anchor Medical Research LLC — Miami, Florida, United States
Links Clinical Trials — Miami, Florida, United States
The Angel Medical Research Corporation — Miami Gardens, Florida, United States
Health Synergy Clinical Research — West Palm Beach, Florida, United States
CenExeli Research LLC — Savannah, Georgia, United States
Revive Research Institute — Elgin, Illinois, United States
Southern Illinois University School of Medicine — Springfield, Illinois, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
UMass Memorial Healthcare — Worcester, Massachusetts, United States
Midwest Research Group — Saint Charles, Missouri, United States
Vector Clinical Trials — Las Vegas, Nevada, United States
Charak Center for Health and Wellness — Garfield, Ohio, United States
Westlake Brain Health — Westlake, Ohio, United States
Access Clinical Trials — Nashville, Tennessee, United States
REX Clinical Trials LLC — Beaumont, Texas, United States
North Pointe Psychiatry — Flower Mound, Texas, United States
Kaleidoscope Clinical Research — Houston, Texas, United States
AIM Trials — Plano, Texas, United States
Perceptive Pharma Research — Richmond, Texas, United States
Clinical Research Partners, LLC — Petersburg, Virginia, United States
Northwest Clinical Research Center — Bellevue, Washington, United States

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment