Clinical Trial

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

Recruiting Phase 3
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Summary
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-11-22; most recent amendment 2026-07-22.
Trial Details
NCT Number NCT06706674
Lead Sponsor Intra-Cellular Therapies, Inc.
Conditions Irritability Associated With Autism Spectrum Disorder
Enrollment 160 participants
Start Date 2024-12-06
Primary Completion 2027-06-21 (estimated)
Study Completion 2027-06-21 (estimated)
Updated on ClinicalTrials.gov 2026-07-31