Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
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
- Irritability Associated With Autism Spectrum Disorder
Eligibility
- Eligible Ages
- Between 5 Years and 17 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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 (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; 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Lumateperone high dose |
Lumateperone 42 mg for patients ages 13-17 years old |
|
|
Experimental Lumateperone low dose |
Lumateperone 21 mg for patients ages 13-17 years old |
|
|
Placebo Comparator Placebo |
Placebo |
|
Recruiting Locations
Pillar Clinical Research, LLC
Little Rock, Arkansas 72204
Little Rock, Arkansas 72204
University Of California - Davis
Sacramento, California 95817
Sacramento, California 95817
California Neuroscience Research
Sherman Oaks, California 91403
Sherman Oaks, California 91403
Yale University School Of Medicine
New Haven, Connecticut 06519
New Haven, Connecticut 06519
United Research Institute
Hialeah, Florida 33012
Hialeah, Florida 33012
Care Research Center Inc
Miami, Florida 33130
Miami, Florida 33130
Blue Medical Research
Miami, Florida 33144
Miami, Florida 33144
New Med Research Inc
Miami Gardens, Florida 33056
Miami Gardens, Florida 33056
APG Research LLC
Orlando, Florida 32803
Orlando, Florida 32803
Clinical Research Center of Florida
Pompano Beach, Florida 33060
Pompano Beach, Florida 33060
University of South Florida Rothman Center of Neuropsychiatry
St. Petersburg, Florida 33701
St. Petersburg, Florida 33701
Advanced Discovery Research
Atlanta, Georgia 30318
Atlanta, Georgia 30318
Salveo Integrative Health Inc
Lawrenceville, Georgia 30046
Lawrenceville, Georgia 30046
EmVenio Research at Chicago
Chicago, Illinois 60622
Chicago, Illinois 60622
Baber Research Group
Naperville, Illinois 60563
Naperville, Illinois 60563
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana 71101
Shreveport, Louisiana 71101
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan 48302
Bloomfield Hills, Michigan 48302
Alivation Research LLC
Lincoln, Nebraska 68526
Lincoln, Nebraska 68526
NYU Child Study Center
New York, New York 10016
New York, New York 10016
Nathan Kline Institute
Orangeburg, New York 10962
Orangeburg, New York 10962
Richmond Behavioral Associates
Staten Island, New York 10314
Staten Island, New York 10314
Advantage Clinical Trials
The Bronx, New York 10467
The Bronx, New York 10467
Quest Therapeutics of Avon Lake
Avon Lake, Ohio 44012
Avon Lake, Ohio 44012
SP Research, PLLC (dba Rivus Wellness & Research Institute)
Oklahoma City, Oklahoma 73112
Oklahoma City, Oklahoma 73112
Sooner Clinical Research
Oklahoma City, Oklahoma 73116
Oklahoma City, Oklahoma 73116
Medical University of South Carolina
Charleston, South Carolina 29425
Charleston, South Carolina 29425
BioBehavioral Research of Austin PC
Austin, Texas 78759
Austin, Texas 78759
Red Oak Psychiatry Associates
Houston, Texas 77090
Houston, Texas 77090
Virginia Commonwealth University
Richmond, Virginia 23220
Richmond, Virginia 23220
Core Clinical Research
Everett, Washington 98201
Everett, Washington 98201
More Details
- Status
- Recruiting
- Sponsor
- Intra-Cellular Therapies, Inc.
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.