Lumateperone for Autism

Recruiting at 33 trial locations

Overseen By ITI Clinical Trials

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Intra-Cellular Therapies, Inc.

Must be taking: ADHD medications

Disqualifiers: Rett syndrome, Fragile X, suicidal risk, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 0

174 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking medication for ADHD, you must be on a stable treatment plan for at least 30 days before the trial and continue it throughout the study.

Eligibility Criteria

This trial is for children aged 5 to 17 with a diagnosis of irritability associated with Autism Spectrum Disorder (ASD), confirmed by specific psychiatric assessments. Details on who can or cannot participate are not fully provided.

Inclusion Criteria

Able to provide consent as follows: The patient's LAR must provide written, informed consent. When developmentally appropriate based on Investigator judgment, the patient should provide written assent.

CGI-S score > 4 with respect to irritability associated with ASD at Screening and Baseline.

ABC-I subscale score of >18 at Screening and Baseline;

Exclusion Criteria

History or current diagnosis of Rett syndrome or Fragile X syndrome;

Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).

In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or: At Screening, the patient scores 'yes' on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (CSSRS) within 6 months prior to Screening or, at Baseline, the patient scores 'yes' on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit; At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or The patient is considered to be an imminent danger to themselves or others.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Double-blind Treatment

Participants are randomized to receive either lumateperone high dose, lumateperone low dose, or placebo once daily for 6 weeks

6 weeks

Safety Follow-up

Participants return to the clinic for a safety follow-up visit approximately 1 week after the last dose of study drug

1 week

Treatment Details

Interventions

• Lumateperone

Trial Overview The study tests two doses of Lumateperone against a placebo in pediatric patients. It's designed to be randomized and double-blind, meaning neither the researchers nor participants know who receives the actual drug or placebo.

Participant Groups

Group I: Lumateperone low dose Experimental Treatment 1 Intervention

Lumateperone 21 mg for patients ages 13-17 years old

Group II: Lumateperone high dose Experimental Treatment 1 Intervention

Lumateperone 42 mg for patients ages 13-17 years old

Group III: Placebo Placebo Group 1 Intervention

Placebo

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+