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

Launched by INTRA-CELLULAR THERAPIES, INC. · Nov 13, 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 study is being conducted at multiple locations and involves random assignment of participants to either receive Lumateperone or a placebo (a pill with no active medication) without knowing which one they are getting. To be eligible for the trial, children must be diagnosed with ASD and show significant irritability symptoms, which will be assessed using specific assessment tools. Parents or legal guardians must provide consent for their child to participate, and older kids (ages 13 to 17) are currently being recruited.

Participants in the study can expect to attend regular visits where their symptoms and well-being will be monitored. They will also have the support of their parents or guardians throughout the process. It’s important to note that children with certain other mental health issues or severe disabilities may not be able to join the study. The goal of this research is to find out if Lumateperone can be a safe and effective treatment option for managing irritability in young people with ASD.

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 (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.