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

NCT06706674 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2025-07-08

No results posted yet for this study

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).

Conditions

  • Irritability Associated With Autism Spectrum Disorder

Interventions

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

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-06
Primary Completion
2027-03-31
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06706674 on ClinicalTrials.gov