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ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)
Sponsor: MapLight Therapeutics
Summary
ML-004-003 is a multi-center, open-label extension study that will enroll approximately 120 adolescent and adult subjects with ASD that have completed study ML-004-002. The primary objective of the study will be to evaluate the safety of ML-004 in subjects with ASD.
Official title: An Open-label Extension Study to Investigate Safety and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).
Key Details
Gender
All
Age Range
12 Years - 46 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2023-06-01
Completion Date
2027-12
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
ML-004 (IR)/(ER) tablet
Participants will receive ML-004 once daily.
Locations (21)
Harmonex Neuroscience Research
Dothan, Alabama, United States
Southwest Autism Research and Resource Center
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
The Children's Research Institute
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 & Neurodevelopment
Columbia, Missouri, United States
Nathan Kline Institute for Psychiatric Research
Orangeburg, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Suburban Research Associates
Media, Pennsylvania, United States
BioBehavioral Research of Austin
Austin, Texas, United States
Road Runner Research, Ltd.
San Antonio, Texas, United States
Family Psychiatry of The Woodlands
The Woodlands, Texas, United States
Brain and Mind Centre
Camperdown, New South Wales, Australia
The Royal Children's Hospital, Murdoch Children's Research Institute
Parkville, Victoria, Australia
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada