NCT06690398

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

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study will be conducted in 3 phases: * Screening Period (up to 14 days) during which patient eligibility will be assessed. * Double-blind Treatment Period (DBTP) (6 weeks) during which all patients will be randomized in a 1:1:1 ratio to receive either lumateperone high dose, lumateperone low dose, or placebo as a once daily dose. * Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up (SFU) visit approximately 1 week after the last dose of study drug.

Conditions

• Irritability Associated With Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Lumateperone high dose	Lumateperone administered orally once daily
DRUG	Lumateperone low dose	Lumateperone administered orally once daily
DRUG	Placebo	Matching Placebo administered orally once daily

Timeline

• Start date: 2024-11-22
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2024-11-15
• Last updated: 2025-07-04

Locations

37 sites across 1 country: United States

Regulatory

• FDA-regulated drug study