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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Intra-Cellular Therapies, Inc. • ClinicalTrials.gov ID: NCT06706674

Registry updated: 2026-09-25
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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 (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.

Conditions

Irritability Associated With Autism Spectrum Disorder

Locations

  • 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
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Official Source

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

View Official Record