Treatment of irritability in children with Autism Spectrum Disorder using Lumateperone

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy of Lumateperone in treating irritability associated with Autism Spectrum Disorder (ASD) in pediatric patients aged 5 to 17 years. The study consists of a screening period to assess eligibility, a 6-week double-blind treatment phase where participants receive either a high dose, low dose of Lumateperone, or a placebo, and a safety follow-up period. The primary diagnosis of ASD will be confirmed using standardized assessment tools. The goal is to determine the safety and effectiveness of Lumateperone in reducing irritability symptoms in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Pillar Clinical Research, LLC
  Little Rock, Arkansas, United States Recruiting
• University Of California - Davis
  Sacramento, California, United States Recruiting
• California Neuroscience Research
  Sherman Oaks, California, United States Recruiting
• Yale University School Of Medicine
  New Haven, Connecticut, United States Recruiting
• United Research Institute
  Hialeah, Florida, United States Recruiting
• Care Research Center Inc
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• KarXT + KarX-EC for irritability in kids and teens with autism

  This study tests whether KarXT plus KarX-EC can reduce irritability in children and adolescents with autism.

  Recruiting at 3 sites Phase 3 Bristol-Myers Squibb · Phoenix, Arizona and 66 other locations · NCT07285798

• KarXT plus KarX-EC for irritability in children and teens with autism

  This study tests whether KarXT with KarX-EC, compared to a matching placebo, can reduce irritability in kids and adolescents who have autism.

  Recruiting at 4 sites Phase 3 Bristol-Myers Squibb · Dothan, Alabama and 40 other locations · NCT07284745

• Treatment of irritability in children with autism using lumateperone

  This study is testing if a medication called lumateperone can help reduce irritability in children with autism, ages 5 to 17.

  Recruiting at 32 sites Phase 3 Intra-Cellular Therapies, Inc. · Dothan, Alabama and 38 other locations · NCT06690398

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.