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

NCT06706674 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: ITI-007-602
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 40

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 (CSSRS) 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 (40)

Pillar Clinical Research, LLC

Little Rock, Arkansas, 72204, United States

RECRUITING

University Of California - Davis

Sacramento, California, 95817, United States

RECRUITING

California Neuroscience Research

Sherman Oaks, California, 91403, United States

RECRUITING

Yale University School Of Medicine

New Haven, Connecticut, 06519, United States

RECRUITING

United Research Institute

Hialeah, Florida, 33012, United States

RECRUITING

Advanced Research Institute of Miami

Homestead, Florida, 33033, United States

SUSPENDED

Vital Care Research

Miami, Florida, 33122, United States

SUSPENDED

Care Research Center Inc

Miami, Florida, 33130, United States

RECRUITING

Blue Medical Research

Miami, Florida, 33144, United States

RECRUITING

AP Medical Research

Miami, Florida, 33165, United States

SUSPENDED

GTL Medical and Research Group

Miami, Florida, 33173, United States

COMPLETED

New Med Research Inc

Miami Gardens, Florida, 33056, United States

RECRUITING

Riveldi Biomedical Research

Miami Lakes, Florida, 33014, United States

SUSPENDED

APG Research LLC

Orlando, Florida, 32803, United States

RECRUITING

Orlando Psychiatric Associates

Orlando, Florida, 32809, United States

COMPLETED

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

RECRUITING

University of South Florida Rothman Center of Neuropsychiatry

St. Petersburg, Florida, 33701, United States

RECRUITING

Advanced Discovery Research

Atlanta, Georgia, 30318, United States

RECRUITING

Salveo Integrative Health Inc

Lawrenceville, Georgia, 30046, United States

RECRUITING

EmVenio Research at Chicago

Chicago, Illinois, 60622, United States

RECRUITING

Baber Research Group

Naperville, Illinois, 60563, United States

RECRUITING

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

COMPLETED

Louisiana State University Health Sciences Center Shreveport

Shreveport, Louisiana, 71101, United States

RECRUITING

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, 48302, United States

RECRUITING

Alivation Research LLC

Lincoln, Nebraska, 68526, United States

RECRUITING

NYU Child Study Center

New York, New York, 10016, United States

RECRUITING

Nathan Kline Institute

Orangeburg, New York, 10962, United States

RECRUITING

Richmond Behavioral Associates

Staten Island, New York, 10314, United States

RECRUITING

Advantage Clinical Trials

The Bronx, New York, 10467, United States

RECRUITING

Quest Therapeutics of Avon Lake

Avon Lake, Ohio, 44012, United States

RECRUITING

SP Research, PLLC (dba Rivus Wellness & Research Institute)

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Sooner Clinical Research

Oklahoma City, Oklahoma, 73116, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

BioBehavioral Research of Austin PC

Austin, Texas, 78759, United States

COMPLETED

Texas Research Group

Coppell, Texas, 75019, United States

RECRUITING

Future Search Trials of Dallas

Dallas, Texas, 75251, United States

COMPLETED

North Texas Clinical Trials

Fort Worth, Texas, 76104, United States

SUSPENDED

Red Oak Psychiatry Associates

Houston, Texas, 77090, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23220, United States

RECRUITING

Core Clinical Research

Everett, Washington, 98201, 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 22, 2024
• First Posted: November 26, 2024
• Study Start: December 6, 2024
• Primary Completion (Estimated): June 21, 2027
• Study Completion (Estimated): June 21, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (40)