Lumateperone for Autism

Recruiting at 7 trial locations

Overseen By ITI Clinical Trials

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Intra-Cellular Therapies, Inc.

Disqualifiers: Suicidal ideation, Cardiac disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

26 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Ability to swallow capsules

I have been diagnosed with ASD and experience irritability.

ABC-I subscale score of ≥12 at Screening

Exclusion Criteria

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lumateperone once daily with varying doses over 5 days

1 week

Daily visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Lumateperone

Trial Overview 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.

Participant Groups

Group I: Group 2 (5 to less than 10 years) Experimental Treatment 4 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 Treatment 2 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

Lumateperone is already approved in United States for the following indications:

Approved in United States as Caplyta for:

• Schizophrenia
• Bipolar I or II disorder (bipolar depression)

Who Is Running the Clinical Trial?

Intra-Cellular Therapies, Inc.

Lead Sponsor

Trials

42

Recruited

10,700+