Last updated on May 2018

A Study to Investigate the Efficacy and Safety of RO5285119 in Participants With Autism Spectrum Disorder (ASD)


Brief description of study

This is a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of RO5285119 in children and adolescents aged 5-17 years with ASD who are high functioning (intelligence quotient [IQ] greater than or equal to [>=] 70). Enrollment will be staggered, starting first with adolescents (aged 13 to 17 years) and then with children (aged 5 to 12 years). Initially, a first cohort of approximately 24 adolescents will be enrolled together. Based on pharmacokinetic evaluation, safety, and tolerability in the first adolescent cohort and determined final doses, enrollment of adolescents will resume and the enrollment of a first cohort of approximately 24 children (aged 5 to 12 years) can commence. Based on acceptable safety and tolerability in the first children cohort and determined final doses, enrollment of children will resume.

Clinical Study Identifier: NCT02901431

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Harmonex Neuroscience Research
Dothan, AL United States
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Southwest Autism Research & Resource Center
Phoenix, AZ United States
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PCSD Feighner Research
San Diego, CA United States
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DBA IMMUNOe Int'l Res Center
Centennial, CO United States
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Sarkis Clinical Trials
Gainesville, FL United States
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Medical Research Group of Central Florida
Orange City, FL United States
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APG- Advanced Psychiatric Group
Orlando, FL United States
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University of South Florida
Saint Petersburg, FL United States
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Rush University Medical Center
Chicago, IL United States
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UMASS Medical School
Worcester, MA United States
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University of Minnesota; Clin. Neuro Research Unit
Minneapolis, MN United States
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Midwest Childrens Health Research Institute
Lincoln, NE United States
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Nathan S. Kline Institute for Psychiatric Research
Orangeburg, NY United States
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Richmond Behavioral Associates
Staten Island, NY United States
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DUKE SCHOOL OF MEDICINE;Duke Center for Autism and Brain Development
Durham, NC United States
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University Hospitals
Cleveland, OH United States
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Ohio State University
Columbus, OH United States
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Cutting Edge Research Group
Oklahoma City, OK United States
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Suburban Research Associates
Media, PA United States
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UPMC Western Psychiatric Institute and Clinic
Pittsburgh, PA United States
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Vanderbilt University Medical Center
Nashville, TN United States
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BioBehavioral Research of Austin, PC
Austin, TX United States
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Relaro Medical Trials
Dallas, TX United States
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Red Oak Psychiatry Associates, PA
Houston, TX United States
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Road Runner Research
San Antonio, TX United States
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Northwest Clinical Research Center
Bellevue, WA United States
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Pacific Institute of Medical Sciences
Bothell, WA United States
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Zain Research LLC
Richland, WA United States
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Seattle Children's Research Institute; Psychiatry and Behavioral Medicine
Seattle, WA United States
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Boston Childrens Hospital
Boston, MA United States
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Albert Einstein College of Medicine
Bronx, NY United States
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University of California at San Francisco
San Francisco, CA United States
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Children's Hospital of Colorado
Aurora, CO United States
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Yale University / Yale-New Haven Hospital
New Haven, CT United States
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Segal trials
North Miami, FL United States
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Capstone Clinical Research
Libertyville, IL United States
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St. Charles Psychiatric Associates
Saint Charles, MO United States
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Center for Autism and the Developing Brain
New York, NY United States
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University of Rochester
Rochester, NY United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, OH United States
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NRC Research Institute
Orange, CA United States
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University of California DAVIS Medical Center; M.I.N.D. Institute, Section of Developmental Behavior
Sacramento, CA United States
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Kennedy Krieger Institute
Baltimore, MD United States
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Neuroscientific Insights
Rockville, MD United States
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Massachusetts General Hospital
Boston, MA United States
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Massachusetts General Hospital
Lexington, MA United States
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Children's Hospital of Philadelphia;Allergy/Immunology Department
Philadelphia, PA United States
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InSite Clinical Research
DeSoto, TX United States
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Core Clinical Research
Everett, WA United States
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