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: 160
• Locations: 1 country
• Sites: 35

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 (35)

Harmonex Neuroscience Research

Dothan, Alabama, 36303, United States

RECRUITING

Southwest Autism Research and Resource Center

Phoenix, Arizona, 85006, United States

RECRUITING

Advanced Research Center Inc

Anaheim, California, 92805, United States

RECRUITING

Excell Research Inc

Oceanside, California, 92056, United States

RECRUITING

Inland Psychiatric Medical Group Inc

Redlands, California, 92373, United States

RECRUITING

Buena Park Research

Upland, California, 91786, United States

COMPLETED

Next Level Clinical Trials, LLC

West Covina, California, 91790, United States

RECRUITING

MCB Clinical Research Centers LLC

Colorado Springs, Colorado, 80910, United States

COMPLETED

Royal Palm Clinical Research

Fort Myers, Florida, 33901, United States

SUSPENDED

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

RECRUITING

Green Leaf Clinical Trials

Jacksonville, Florida, 32258, United States

RECRUITING

Columbus Clinical Services LLC

Miami, Florida, 33125, United States

RECRUITING

South Florida Research Phase I-IV

Miami, Florida, 33166, United States

RECRUITING

Diverse Clinical Research LLC

Miami, Florida, 33175, United States

RECRUITING

Anchor Medical Research LLC

Miami, Florida, 33176, United States

RECRUITING

Links Clinical Trials

Miami, Florida, 33176, United States

SUSPENDED

The Angel Medical Research Corporation

Miami Gardens, Florida, 33169, United States

RECRUITING

Health Synergy Clinical Research

West Palm Beach, Florida, 33407, United States

RECRUITING

CenExeli Research LLC

Savannah, Georgia, 31405, United States

RECRUITING

Revive Research Institute

Elgin, Illinois, 60123, United States

RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, 62701, United States

SUSPENDED

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

COMPLETED

UMass Memorial Healthcare

Worcester, Massachusetts, 01655, United States

RECRUITING

Midwest Research Group

Saint Charles, Missouri, 63304, United States

RECRUITING

Vector Clinical Trials

Las Vegas, Nevada, 89128, United States

RECRUITING

Charak Center for Health and Wellness

Garfield, Ohio, 44125, United States

RECRUITING

Westlake Brain Health

Westlake, Ohio, 44145, United States

COMPLETED

Access Clinical Trials

Nashville, Tennessee, 37203, United States

RECRUITING

REX Clinical Trials LLC

Beaumont, Texas, 77701, United States

RECRUITING

North Pointe Psychiatry

Flower Mound, Texas, 76028, United States

RECRUITING

Kaleidoscope Clinical Research

Houston, Texas, 77089, United States

RECRUITING

AIM Trials

Plano, Texas, 75093, United States

RECRUITING

Perceptive Pharma Research

Richmond, Texas, 77407, United States

RECRUITING

Clinical Research Partners, LLC

Petersburg, Virginia, 23805, United States

RECRUITING

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

RECRUITING

MeSH Terms

Interventions

lumateperone

Study Officials

• Intra-Cellular Therapies, Inc. Clinical Trial

  Intra-Cellular Therapies, Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.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): June 21, 2027
• Study Completion (Estimated): July 19, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (35)