Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
Launched by INTRA-CELLULAR THERAPIES, INC. · Nov 22, 2024
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called Lumateperone to see if it can help reduce irritability in children and teenagers aged 5 to 17 who have Autism Spectrum Disorder (ASD). The trial is being conducted at multiple locations and is designed to compare the effects of Lumateperone to a placebo (a treatment that looks like the drug but has no active ingredients) to find out if Lumateperone is more effective. To be eligible for the study, participants must have a confirmed diagnosis of ASD and show significant irritability symptoms. They will need to have a parent or legal guardian who can provide consent and support them throughout the trial.
If your child is eligible and decides to participate, they will be randomly assigned to receive either Lumateperone or the placebo for a certain period. Throughout the study, researchers will monitor their progress and any changes in irritability. It's important for families to know that safety is a top priority, and the study has specific guidelines to ensure the well-being of all participants. This trial aims to provide more information about how Lumateperone can potentially help children with ASD manage their irritability.
Gender
ALL
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.
About Intra Cellular Therapies, Inc.
Intra-Cellular Therapies, Inc. is a biopharmaceutical company dedicated to the development of innovative therapies for neuropsychiatric and other central nervous system disorders. The company focuses on leveraging its proprietary technologies to explore novel mechanisms of action, aiming to address unmet medical needs in complex conditions such as schizophrenia, bipolar disorder, and depression. Intra-Cellular Therapies is committed to advancing clinical research and improving patient outcomes through rigorous scientific inquiry, robust clinical trials, and a patient-centered approach to drug development.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Sherman Oaks, California, United States
Dallas, Texas, United States
Miami, Florida, United States
Charleston, South Carolina, United States
Hialeah, Florida, United States
Avon Lake, Ohio, United States
Orlando, Florida, United States
Lawrenceville, Georgia, United States
Indianapolis, Indiana, United States
Oklahoma City, Oklahoma, United States
Sacramento, California, United States
Miami Lakes, Florida, United States
Atlanta, Georgia, United States
Lincoln, Nebraska, United States
Kinston, North Carolina, United States
Austin, Texas, United States
Houston, Texas, United States
Miami Gardens, Florida, United States
Little Rock, Arkansas, United States
Imperial, California, United States
New Haven, Connecticut, United States
Pompano Beach, Florida, United States
Naperville, Illinois, United States
Evansville, Indiana, United States
Bloomfield Hills, Michigan, United States
Saint Louis, Missouri, United States
Bronx, New York, United States
Orangeburg, New York, United States
Staten Island, New York, United States
Coppell, Texas, United States
Fort Worth, Texas, United States
Richmond, Virginia, United States
Everett, Washington, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported