Study of Lumateperone to Treat Irritability in Children and Teens with Autism Spectrum Disorder Ages 5 to 17

What this Trial Is About

Researchers are evaluating lumateperone for treating irritability in children and adolescents aged 5 to 17 years diagnosed with Autism Spectrum Disorder ASD. This randomized, double-blind, placebo-controlled study focuses on pediatric patients with confirmed ASD diagnosis and irritability symptoms as measured by specific behavioral scales. Participants will be randomly assigned to receive either a high dose or low dose of lumateperone, or a placebo, taken orally once daily during a 6-week double-blind treatment period. The study includes a screening period up to 14 days to confirm eligibility, followed by a 1-week safety follow-up visit after the last dose. During the trial, participants will undergo assessments including behavior checklists for irritability and clinical global impression scales at week 6. Safety and tolerability will be monitored throughout the study. The total participation time includes screening, 6 weeks of treatment, and a safety follow-up week, with regular visits to the clinic for evaluations.

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