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ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)
Sponsor: MapLight Therapeutics
Summary
ML-004-002 is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective is to evaluate the efficacy of ML-004 compared with placebo in the improvement of social communication deficits in subjects with ASD.
Official title: A Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).
Key Details
Gender
All
Age Range
12 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2022-09-13
Completion Date
2026-11
Last Updated
2025-12-22
Healthy Volunteers
No
Conditions
Interventions
ML-004 (IR)/(ER) tablet
Participants will receive ML-004 once daily.
ML-004 Placebo
Participants will receive matching placebo once daily.
Locations (29)
Harmonex Neuroscience Research
Dothan, Alabama, United States
Southwest Autism Research & Resource Center, Clinical Research
Phoenix, Arizona, United States
Cortica Healthcare
Glendale, California, United States
NRC Research Institute
Orange, California, United States
Cortica
San Rafael, California, United States
Yale Child Study Center
New Haven, Connecticut, United States
Children's National Health System - The Children's Research Institute (CRI)
Washington D.C., District of Columbia, United States
Abba Medical Group
Miami, Florida, United States
APG Research, LLC
Orlando, Florida, United States
University of South Florida Psychiatry and Behavioral Neurosciences
Tampa, Florida, United States
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States
University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders
Columbia, Missouri, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Nathan Kline Institute for Psychiatric Research
Orangeburg, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Center for Autism and the Developing Brain, New York State Psychiatric Institute
White Plains, New York, United States
Ohio State University Nisonger Center
Columbus, Ohio, United States
Suburban Research Associates
Media, Pennsylvania, United States
BioBehavioral Research of Austin
Austin, Texas, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, United States
Road Runner Research, Ltd.
San Antonio, Texas, United States
Family Psychiatry of The Woodlands
The Woodlands, Texas, United States
Cedar Clinical Research
Draper, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Brain and Mind Centre
Camperdown, New South Wales, Australia
The Royal Children's Hospital, Murdoch Children's Research Institute
Parkville, Victoria, Australia
OCT Research ULC (dba Okanagan Clinical Trials)
Kelowna, British Columbia, Canada
Lawson Health Research Institute/ London Health Sciences Centre
London, Ontario, Canada
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada