Evaluating lumateperone for children with autism

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

This study is testing a new medication called lumateperone to see if it is safe and helpful for children with autism who struggle with irritability.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Ages: 5 Years to 12 Years
• Sex: All
• Sponsor: Intra-Cellular Therapies, Inc. (Industry-sponsored)
• Locations: 8 sites (Miami, Florida and 7 other locations)
• Trial ID: NCT06557902 on ClinicalTrials.gov

What this trial studies

This Phase 1b clinical trial aims to assess the safety, tolerability, and pharmacokinetics of lumateperone in pediatric patients diagnosed with Autism Spectrum Disorder (ASD). The study involves administering various formulations of lumateperone to children aged 5 to less than 13 years who exhibit symptoms of irritability associated with ASD. Participants will be monitored for any adverse effects and how well their bodies process the medication. The trial is open-label and multicenter, meaning it will take place at multiple locations to gather diverse data.

Who should consider this trial

Good fit: Ideal candidates are children aged 5 to less than 13 years with a clinical diagnosis of Autism Spectrum Disorder and symptoms of irritability.

Not a fit: Patients with primary psychiatric diagnoses other than ASD or those with significant safety risks will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for managing irritability in children with autism.

How similar studies have performed: While this approach is novel in the context of lumateperone for pediatric ASD, similar studies have shown promise in evaluating treatments for irritability in autism.

Eligibility criteria

Inclusion 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

Exclusion Criteria:

* 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

Where this trial is running

Miami, Florida and 7 other locations

• Clinical Site 6 — Miami, Florida, United States (Not_yet_recruiting)
• Clinical Site 7 — Orlando, Florida, United States (Not_yet_recruiting)
• Clinical Site 1 — Atlanta, Georgia, United States (Recruiting)
• Clinical Site 2 — Decatur, Georgia, United States (Recruiting)
• Clinical Site 3 — Savannah, Georgia, United States (Recruiting)
• Clinical Site 4 — Saint Charles, Missouri, United States (Recruiting)
• Clinical Site 5 — Lincoln, Nebraska, United States (Recruiting)
• Clinical Site 8 — Everett, Washington, United States (Recruiting)

Study contacts

• Study coordinator: ITI Clinical Trials

Conditions Autism Spectrum Disorder