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

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.