Study of Lumateperone to Treat Irritability in Children and Teens Ages 13 to 17 with Autism Spectrum Disorder

What this Trial Is About

Researchers are evaluating lumateperone for treating irritability in pediatric patients aged 5 to 17 years diagnosed with Autism Spectrum Disorder ASD based on DSM-5-TR criteria and confirmed by K-SADS-PL. This multicenter, randomized, double-blind, placebo-controlled Phase 3 study aims to understand the effects and safety of lumateperone in this population. The study includes three phases a screening period lasting up to 14 days to assess eligibility a 6-week double-blind treatment period where patients are randomly assigned to receive either a high dose of lumateperone 42 mg for ages 13-17, a low dose of lumateperone 21 mg for ages 13-17, or placebo once daily and a safety follow-up visit about one week after the last dose to monitor safety. Participants will attend clinic visits for screening, treatment, and safety follow-up. Researchers will assess irritability using the Aberrant Behavior Checklist - Irritability subscale ABC-I at week 6 as the primary outcome, alongside secondary measures like Clinical Global Impression-Severity CGI-S. Safety and well-being will be monitored throughout, with the entire study lasting approximately 7 weeks from screening to follow-up.

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