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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 5 Years and 17 Years
Eligible Sex
All
Accepts 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 to 17 years will be eligible for enrollment. 4. Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL); 5. ABC-I subscale score of >18 at Screening and Baseline; 6. CGI-S score > 4 with respect to irritability associated with ASD at Screening and Baseline.

Exclusion Criteria

  1. Has a primary psychiatric diagnosis other than ASD. Exceptions include: 1. Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records. 2. Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded). 2. History or current diagnosis of Rett syndrome or Fragile X syndrome; 3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or 1. At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) 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; 2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or 3. The patient is considered to be an imminent danger to themselves or others.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Lumateperone high dose 		Lumateperone 42 mg for patients ages 13-17 years old
  • Drug: Lumateperone high dose
    Lumateperone administered orally once daily
Experimental
Lumateperone low dose 		Lumateperone 21 mg for patients ages 13-17 years old
  • Drug: Lumateperone low dose
    Lumateperone administered orally once daily
Placebo Comparator
Placebo 		Placebo
  • Drug: Placebo
    Matching Placebo administered orally once daily

Recruiting Locations

Harmonex Neuroscience Research
Dothan, Alabama 36303

Southwest Autism Research and Resource Center
Phoenix, Arizona 85006

Advanced Research Center Inc
Anaheim, California 92805

Excell Research Inc
Oceanside, California 92056

Inland Psychiatric Medical Group Inc
Redlands, California 92373

Next Level Clinical Trials, LLC
West Covina, California 91790

Sarkis Clinical Trials
Gainesville, Florida 32607

Green Leaf Clinical Trials
Jacksonville, Florida 32258

South Florida Research Phase I-IV
Miami, Florida 33166

Diverse Clinical Research LLC
Miami, Florida 33175

Anchor Medical Research LLC
Miami, Florida 33176

Links Clinical Trials
Miami, Florida 33176

The Angel Medical Research Corporation
Miami Gardens, Florida 33169

Health Synergy Clinical Research
West Palm Beach, Florida 33407

CenExeli Research LLC
Savannah, Georgia 31405

Revive Research Institute
Elgin, Illinois 60123

Midwest Research Group
Saint Charles, Missouri 63304

Vector Clinical Trials
Las Vegas, Nevada 89128

Charak Center for Health and Wellness
Garfield, Ohio 44125

Access Clinical Trials
Nashville, Tennessee 37203

REX Clinical Trials LLC
Beaumont, Texas 77701

North Pointe Psychiatry
Flower Mound, Texas 76028

Kaleidoscope Clinical Research
Houston, Texas 77089

AIM Trials
Plano, Texas 75093

Perceptive Pharma Research
Richmond, Texas 77407

Clinical Research Partners, LLC
Petersburg, Virginia 23805

Northwest Clinical Research Center
Bellevue, Washington 98007

More Details

Status
Recruiting
Sponsor
Intra-Cellular Therapies, Inc.

Study Contact

ITI Clinical Trials
646 440-9333
ITCIClinicalTrials@itci-inc.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.