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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 6

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met