A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated with Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age

LH

Leslie Hulvershorn, MD, MSc

Principal Investigator

Status: Recruiting Ages: 5 Years - 17 Years Gender: All Genders Phase: N/A 1 Locations

Brief Description

This is a multicenter study in pediatric patients aged 5 to 17 years with a primary diagnosis of Autism Spectrum Disorder associated with irritability to evaluate the efficacy of high and low doses of lumateperone compared to placebo for the treatment of irritability associated with Autism Spectrum Disorder and to determine the safety and tolerability of high and low doses of lumateperone compared to placebo.

Note: We are currently enrolling patients age 13-17 years old only 

Detailed Description

The study will be conducted in 3 phases:

  • Screening Period (up to 14 days) during which patient eligibility will be assessed.
  • Double-blind Treatment Period (DBTP) (6 weeks) during which all patients will be randomized in a 1:1:1 ratio to receive either lumateperone high dose, lumateperone low dose, or placebo as a once daily dose.
  • Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up (SFU) visit approximately 1 week after the last dose of study drug.

Eligibility of study

Inclusion Criteria:

  1. The Child has a legally authorized representative (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the child, provide information about the patient's condition, and accompany the patient to study visits.
  2. Able to provide consent as follows:
    1. The child's legally authorized representative must provide written, informed consent.
    2. The patient should provide written assent when developmentally appropriate.
  3. The child is a male or female and is 5 to 17 years of age
  4. The child has an official primary diagnosis of Autism Spectrum Disorder
  5. The child is able to swallow capsules

Note: We are currently enrolling patients age 13-17 years old only 

Exclusion Criteria:

  1. The child has a primary psychiatric diagnosis other than Autism Spectrum Disorder, Except Attention Deficit Hyperactivity Disorder (ADHD) and Mild and moderate intellectual disability
  2. The child has a history or current diagnosis of Rett syndrome or Fragile X syndrome
  3. The child has a history of suicidal intent, suicidal plan or suicidal attempt in the past 2 years
  4. The child is considered to be an imminent danger to themselves or others.

Other inclusion and exclusion criteria may apply

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.