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
Intra-Cellular Therapies, Inc.
Summary
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).
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
- Age range
- 5–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patient's condition, and accompany the patient to study visits. 2. Able to provide consent as follows: 1. The patient's LAR must provide written, informed consent. 2. When developmentally appropriate based on Investigator judgment, the patient should provide written assent. 3. Male or female patients 5 to 17 years of age. Currently, only patients aged 13…
Interventions
- DrugLumateperone high dose
Lumateperone administered orally once daily
- DrugLumateperone low dose
Lumateperone administered orally once daily
- DrugPlacebo
Matching Placebo administered orally once daily
Locations (39)
- Clinical SiteLittle Rock, Arkansas
- Clinical SiteImperial, California
- Clinical SiteSacramento, California
- Clinical SiteSherman Oaks, California
- Clinical SiteNew Haven, Connecticut
- Clinical SiteHialeah, Florida