RECRUITING

Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Study ITI-007-035 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone for pediatric patients with Autism Spectrum Disorder.

Official Title

An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumateperone in Pediatric Patients, Ages 5 to Less Than 13 Years, Diagnosed With Autism Spectrum Disorder

Quick Facts

Study Start:2024-05-10

Study Completion:2026-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06557902

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.

Ages Eligible for Study:5 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Male or female patients between 5 to less than 13 years of age * Primary clinical diagnosis of ASD with symptoms of irritability * ABC-I subscale score of ≥12 at Screening * CGI-S score of ≥3 at Screening * Body mass index (BMI) greater than the 5th percentile according to age- and gender-specific CDC Clinical Growth Charts (2000) at Screening * Ability to swallow capsules	* Has a primary psychiatric diagnosis other than ASD * Reports suicidal ideation (Type 3, 4 or 5 on the Baseline/Screening version of the C-SSRS) within 6 months prior to Screening, or any suicidal behavior within 2 years prior to Screening, and/or the Investigator assesses the patient to be a safety risk to him/herself or others * Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables * History of a clinically significant cardiac disorder and/or abnormal screening ECG or a QT interval corrected for heart rate using Fridericia formula (QTcF) \> 460 msec at Screening * Patients with a history of orthostatic hypotension or who have orthostatic hypotension at Screening * Has a history of uncontrolled/disruptive behavior in the past 30 days that, in the Investigator's opinion, would preclude the ability to participate in study procedures

Inclusion Criteria

Exclusion Criteria

* Male or female patients between 5 to less than 13 years of age
* Primary clinical diagnosis of ASD with symptoms of irritability
* ABC-I subscale score of ≥12 at Screening
* CGI-S score of ≥3 at Screening
* Body mass index (BMI) greater than the 5th percentile according to age- and gender-specific CDC Clinical Growth Charts (2000) at Screening
* Ability to swallow capsules

* Has a primary psychiatric diagnosis other than ASD
* Reports suicidal ideation (Type 3, 4 or 5 on the Baseline/Screening version of the C-SSRS) within 6 months prior to Screening, or any suicidal behavior within 2 years prior to Screening, and/or the Investigator assesses the patient to be a safety risk to him/herself or others
* Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables
* History of a clinically significant cardiac disorder and/or abnormal screening ECG or a QT interval corrected for heart rate using Fridericia formula (QTcF) \> 460 msec at Screening
* Patients with a history of orthostatic hypotension or who have orthostatic hypotension at Screening
* Has a history of uncontrolled/disruptive behavior in the past 30 days that, in the Investigator's opinion, would preclude the ability to participate in study procedures

Contacts and Locations

Study Contact

ITI Clinical Trials

CONTACT

6464409333

ITCIClinicalTrials@itci-inc.com

Study Locations (Sites)

Clinical Site 6

Miami, Florida, 33133

United States

Clinical Site 7

Orlando, Florida, 32803

United States

Clinical Site 1

Atlanta, Georgia, 30331

United States

Clinical Site 2

Decatur, Georgia, 30030

United States

Clinical Site 3

Savannah, Georgia, 31405

United States

Clinical Site 4

Saint Charles, Missouri, 63304

United States

Clinical Site 5

Lincoln, Nebraska, 68526

United States

Clinical Site 8

Everett, Washington, 98201

United States

Collaborators and Investigators

Sponsor: 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 Registration Dates

Study Start Date2024-05-10

Study Completion Date2026-07-31

Study Record Updates

Study Start Date2024-05-10

Study Completion Date2026-07-31

Terms related to this study

Additional Relevant MeSH Terms

Autism Spectrum Disorder