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

July 3, 2025 updated by: Intra-Cellular Therapies, Inc.

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
174

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • Clinical Site
    • California
      • Imperial, California, United States, 92251
        • Not yet recruiting
        • Clinical Site
      • Sacramento, California, United States, 95817
        • Not yet recruiting
        • Clinical Site
      • Sherman Oaks, California, United States, 91403
        • Recruiting
        • Clinical Site
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Not yet recruiting
        • Clinical Site
    • Florida
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33122
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33144
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33130
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33165
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33173
        • Recruiting
        • Clinical Site
      • Miami Gardens, Florida, United States, 33056
        • Recruiting
        • Clinical Site
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Clinical Site
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Clinical Site
      • Orlando, Florida, United States, 32809
        • Recruiting
        • Clinical Site
      • Pompano Beach, Florida, United States, 33060
        • Recruiting
        • Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Clinical Site
      • Lawrenceville, Georgia, United States, 30046
        • Recruiting
        • Clinical Site
    • Illinois
      • Naperville, Illinois, United States, 60563
        • Recruiting
        • Clinical Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Not yet recruiting
        • Clinical Site
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Clinical Site
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48302
        • Recruiting
        • Clinical Site
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Not yet recruiting
        • Clinical Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Recruiting
        • Clinical Site
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Clinical Site
      • Orangeburg, New York, United States, 10962
        • Recruiting
        • Clinical Site
      • Staten Island, New York, United States, 10314
        • Recruiting
        • Clinical Site
    • North Carolina
      • Kinston, North Carolina, United States, 28504
        • Not yet recruiting
        • Clinical Site
    • Ohio
      • Avon Lake, Ohio, United States, 44012
        • Recruiting
        • Clinical Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Recruiting
        • Clinical Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Not yet recruiting
        • Clinical Site
    • Texas
      • Austin, Texas, United States, 78759
        • Recruiting
        • Clinical Site
      • Coppell, Texas, United States, 75019
        • Not yet recruiting
        • Clinical Site
      • Dallas, Texas, United States, 75251
        • Recruiting
        • Clinical Site
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Clinical Site
      • Houston, Texas, United States, 77090
        • Recruiting
        • Clinical Site
    • Virginia
      • Richmond, Virginia, United States, 23220
        • Recruiting
        • Clinical Site
    • Washington
      • Everett, Washington, United States, 98201
        • Recruiting
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.

  2. Able to provide consent as follows:

    1. The patient's LAR must provide written, informed consent.
    2. When developmentally appropriate based on Investigator judgment, the patient should provide written assent.
  3. Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
  4. 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);
  5. ABC-I subscale score of >18 at Screening and Baseline;
  6. CGI-S score > 4 with respect to irritability associated with ASD at Screening and Baseline.

Exclusion Criteria:

  1. Has a primary psychiatric diagnosis other than ASD. Exceptions include:

    1. 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.
    2. Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).
  2. History or current diagnosis of Rett syndrome or Fragile X syndrome;

  3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or

    1. 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;
    2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
    3. The patient is considered to be an imminent danger to themselves or others.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Matching Placebo administered orally once daily
Experimental: Lumateperone high dose
Lumateperone 42 mg for patients ages 13-17 years old
Drug: Lumateperone high dose
Lumateperone administered orally once daily
Experimental: Lumateperone low dose
Lumateperone 21 mg for patients ages 13-17 years old
Drug: Lumateperone low dose
Lumateperone administered orally once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Aberrant Behavior Checklist - Irritability (ABC-I)
Time Frame: Week 6
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Global Impression-Severity (CGI-S)
Time Frame: Week 6
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intra-Cellular Therapies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ITI-007-602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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