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
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:
• 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.
• 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.
• Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
• 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);
• ABC-I subscale score of \>18 at Screening and Baseline;
• CGI-S score \> 4 with respect to irritability associated with ASD at Screening and Baseline.
Locations
United States
Arkansas
Pillar Clinical Research, LLC
RECRUITING
Little Rock
California
University Of California - Davis
RECRUITING
Sacramento
California Neuroscience Research
RECRUITING
Sherman Oaks
Connecticut
Yale University School Of Medicine
RECRUITING
New Haven
Florida
United Research Institute
RECRUITING
Hialeah
Advanced Research Institute of Miami
SUSPENDED
Homestead
AP Medical Research
SUSPENDED
Miami
Blue Medical Research
RECRUITING
Miami
Care Research Center Inc
RECRUITING
Miami
GTL Medical and Research Group
COMPLETED
Miami
Vital Care Research
SUSPENDED
Miami
New Med Research Inc
RECRUITING
Miami Gardens
Riveldi Biomedical Research
SUSPENDED
Miami Lakes
APG Research LLC
RECRUITING
Orlando
Orlando Psychiatric Associates
COMPLETED
Orlando
Clinical Research Center of Florida
RECRUITING
Pompano Beach
University of South Florida Rothman Center of Neuropsychiatry
RECRUITING
St. Petersburg
Georgia
Advanced Discovery Research
COMPLETED
Atlanta
Salveo Integrative Health Inc
COMPLETED
Lawrenceville
Illinois
EmVenio Research at Chicago
RECRUITING
Chicago
Baber Research Group
RECRUITING
Naperville
Indiana
Riley Hospital for Children at Indiana University Health
COMPLETED
Indianapolis
Louisiana
Louisiana State University Health Sciences Center Shreveport
RECRUITING
Shreveport
Michigan
Neurobehavioral Medicine Group
RECRUITING
Bloomfield Hills
Nebraska
Alivation Research LLC
RECRUITING
Lincoln
New York
NYU Child Study Center
RECRUITING
New York
Nathan Kline Institute
RECRUITING
Orangeburg
Richmond Behavioral Associates
RECRUITING
Staten Island
Advantage Clinical Trials
RECRUITING
The Bronx
Ohio
Quest Therapeutics of Avon Lake
RECRUITING
Avon Lake
Oklahoma
Sooner Clinical Research
RECRUITING
Oklahoma City
SP Research, PLLC (dba Rivus Wellness & Research Institute)
RECRUITING
Oklahoma City
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
BioBehavioral Research of Austin PC
COMPLETED
Austin
Texas Research Group
RECRUITING
Coppell
Future Search Trials of Dallas
COMPLETED
Dallas
North Texas Clinical Trials
SUSPENDED
Fort Worth
Red Oak Psychiatry Associates
RECRUITING
Houston
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Washington
Core Clinical Research
RECRUITING
Everett
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date:2024-12-06
Estimated Completion Date:2027-06-21
Participants
Target number of participants:160
Treatments
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