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

NCT06690398 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: ITI-007-601
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 37

Brief 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

Outcome Measures

Primary Outcomes (1)

• Aberrant Behavior Checklist - Irritability (ABC-I)

  The ABC-I subscale contains 15 items which rate symptoms on a scale ranging from 0 (not at all a problem) to 3 (severe).

  Week 6

Secondary Outcomes (1)

• Clinical Global Impression-Severity (CGI-S)

  Week 6

Study Arms (3)

Lumateperone high dose

EXPERIMENTAL

Lumateperone 42 mg for patients ages 13-17 years old

Drug: Lumateperone high dose

Lumateperone low dose

EXPERIMENTAL

Lumateperone 21 mg for patients ages 13-17 years old

Drug: Lumateperone low dose

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Lumateperone high dose DRUG

Lumateperone administered orally once daily

Lumateperone high dose

Lumateperone low dose DRUG

Lumateperone administered orally once daily

Lumateperone low dose

Placebo DRUG

Matching Placebo administered orally once daily

Placebo

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patient's condition, and accompany the patient to study visits.
• Able to provide consent as follows:
• The patient's LAR must provide written, informed consent.
• When developmentally appropriate based on Investigator judgment, the patient should provide written assent.
• Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
• Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
• ABC-I subscale score of \>18 at Screening and Baseline;
• CGI-S score \> 4 with respect to irritability associated with ASD at Screening and Baseline.

You may not qualify if:

• Has a primary psychiatric diagnosis other than ASD. Exceptions include:
• Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.
• Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).
• History or current diagnosis of Rett syndrome or Fragile X syndrome;
• In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or
• At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;
• At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
• The patient is considered to be an imminent danger to themselves or others.

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (37)

Clinical Site

Dothan, Alabama, 36303, United States

RECRUITING

Clinical Site

Peoria, Arizona, 85382, United States

NOT YET RECRUITING

Clinical Site

Phoenix, Arizona, 85006, United States

RECRUITING

Clinical Site

Anaheim, California, 92805, United States

RECRUITING

Clinical Site

Buena Park, California, 90621, United States

NOT YET RECRUITING

Clinical Site

Corona, California, 92879, United States

NOT YET RECRUITING

Clinical Site

Oceanside, California, 92056, United States

RECRUITING

Clinical Site

Redlands, California, 92373, United States

RECRUITING

Clinical Site

Upland, California, 91786, United States

RECRUITING

Clinical Site

West Covina, California, 91790, United States

RECRUITING

Clinical Site

Colorado Springs, Colorado, 80910, United States

RECRUITING

Clinical Site

Gainesville, Florida, 32607, United States

RECRUITING

Clinical Site

Jacksonville, Florida, 32258, United States

RECRUITING

Clinical Site

Miami, Florida, 33125, United States

RECRUITING

Clinical Site

Miami, Florida, 33175, United States

RECRUITING

Clinical Site

Miami, Florida, 33176, United States

RECRUITING

Clinical Site

Miami, Florida, 33186, United States

RECRUITING

Clinical Site

Miami Lakes, Florida, 33016, United States

RECRUITING

Clinical Site

Miami Springs, Florida, 33166, United States

RECRUITING

Clinical Site

West Palm Beach, Florida, 33407, United States

RECRUITING

Clinical Site

Savannah, Georgia, 31405, United States

RECRUITING

Clinical Site

Arlington Heights, Illinois, 60005, United States

NOT YET RECRUITING

Clinical Site

Springfield, Illinois, 62701, United States

RECRUITING

Clinical Site

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Clinical Site

Saint Charles, Missouri, 63304, United States

RECRUITING

Clinical Site

Las Vegas, Nevada, 89128, United States

RECRUITING

Clinical Site

Cincinnati, Ohio, 45229, United States

NOT YET RECRUITING

Clinical Site

Garfield, Ohio, 44125, United States

RECRUITING

Clinical Site

Westlake, Ohio, 44145, United States

RECRUITING

Clinical Site

Nashville, Tennessee, 37203, United States

RECRUITING

Clinical Site

Dallas, Texas, 75251, United States

NOT YET RECRUITING

Clinical Site

Frisco, Texas, 75034, United States

NOT YET RECRUITING

Clinical Site

Houston, Texas, 77089, United States

RECRUITING

Clinical Site

Plano, Texas, 75093, United States

RECRUITING

Clinical Site

Richmond, Texas, 77407, United States

RECRUITING

Clinical Site

Petersburg, Virginia, 23805, United States

RECRUITING

Clinical Site

Bellevue, Washington, 98007, United States

RECRUITING

MeSH Terms

Interventions

lumateperone

Central Study Contacts

ITI Clinical Trials

CONTACT

646 440-9333; ITCIClinicalTrials@itci-inc.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: November 22, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (37)