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Antipsychotic

Lumateperone for Autism

Phase 1
Recruiting
Research Sponsored by Intra-Cellular Therapies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary clinical diagnosis of ASD with symptoms of irritability
Body mass index (BMI) greater than the 5th percentile according to age- and gender-specific CDC Clinical Growth Charts (2000) at Screening
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 6
Awards & highlights

Summary

"This trial is testing a new medication called lumateperone on children with Autism Spectrum Disorder to see if it is safe and well-tolerated."

Who is the study for?
This trial is for pediatric patients with Autism Spectrum Disorder. Specific details about who can join are not provided, but typically participants must meet certain health criteria and may need parental consent due to their age.
What is being tested?
The study is testing the safety, how well it's tolerated, and how the body processes various doses of Lumateperone (a drug) in different forms like capsules or orally disintegrating tablets (ODTs) in children with Autism Spectrum Disorder.
What are the potential side effects?
Since this is a Phase 1b trial primarily focused on safety and tolerability, specific side effects are not listed. However, common clinical trial side effects could include nausea, headaches, sleepiness or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with ASD and experience irritability.
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My BMI is above the 5th percentile for my age and gender.
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I am between 5 and 12 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a heart condition or an abnormal heart rhythm test result.
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I have a history of or currently experience sudden blood pressure drops when standing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pharmacokinetics: AUC0-tau
Pharmacokinetics: Cmax
Pharmacokinetics: Tmax
Secondary study objectives
Change from baseline in Abnormal Involuntary Movement Scale (AIMS)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2 (5 to less than 10 years)Experimental Treatment4 Interventions
Lumateperone ODT once daily: 5 mg on Days 1 and 2; 5 mg or 10.5 mg on Day 3; 5 mg or 10.5 mg on Days 4 and 5; dosing regimen may be adjusted after the first 6 patients dosed and will not exceed 21 mg in subsequent patients
Group II: Group 1 (10 to less than 13 years)Experimental Treatment2 Interventions
Lumateperone capsule once daily: 10.5 mg on Days 1 and 2; 10.5 mg or 21 mg on Day 3; 10.5 mg or 21 mg on Days 4 and 5

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Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
35 Previous Clinical Trials
9,306 Total Patients Enrolled
~17 spots leftby Jul 2026
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