Phase
Condition
Autism Spectrum Disorder (Asd)
Asperger's Disorder
Autism
Treatment
ML-004 (IR)/(ER) tablet
Clinical Study ID
Ages 12-46 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has completed Study ML-004-002 within the past 90 days
Age 12 years to 46 years at screening
Has a designated care/study partner who can reliably report on symptoms
Has a diagnosis of Autism Spectrum Disorder (ASD)
Has a body mass index (BMI) ≥18 kg/m²
Psychoactive medications and adjunctive therapies stable for 4 weeks prior toscreening
Must be able to swallow study medication
Exclusion
Exclusion Criteria:
Has Rett syndrome or Child Disintegrative Disorder
History of epilepsy without current adequate control, or any seizure in the 6 monthspreceding screening
Has a positive response to C-SSRS questions 4 and/or 5, or is a significant risk forsuicidal behavior
Has a clinical history of uncontrolled or severe hypertension
If female, is pregnant or lactating
Study Design
Connect with a study center
Brain and Mind Centre
Camperdown, New South Wales 2050
AustraliaSite Not Available
The Royal Children's Hospital, Murdoch Children's Research Institute
Parkville, Victoria 3052
AustraliaSite Not Available
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario M4G 1R8
CanadaSite Not Available
Harmonex Neuroscience Research
Dothan, Alabama 36303
United StatesSite Not Available
Southwest Autism Research and Resource Center
Phoenix, Arizona 85006
United StatesSite Not Available
Cortica Healthcare
Glendale, California 91203
United StatesSite Not Available
NRC Research Institute
Orange, California 92868
United StatesSite Not Available
APG Research, LLC
Orlando, Florida 32803
United StatesSite Not Available
University of South Florida Psychiatry and Behavioral Neurosciences
Tampa, Florida 33613
United StatesSite Not Available
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan 48302
United StatesSite Not Available
University of Missouri, Thompson Center for Autism & Neurodevelopment
Columbia, Missouri 65211
United StatesSite Not Available
Nathan Kline Institute for Psychiatric Research
Orangeburg, New York 10962
United StatesSite Not Available
Richmond Behavioral Associates
Staten Island, New York 10314
United StatesSite Not Available
Ohio State University Nisonger Center
Columbus, Ohio 43210
United StatesSite Not Available
Suburban Research Associates
Media, Pennsylvania 19063
United StatesSite Not Available
Red Oak Psychiatry Associates, PA
Houston, Texas 77090
United StatesSite Not Available
Road Runner Research, Ltd.
San Antonio, Texas 78249
United StatesSite Not Available
Cedar Clinical Research
Draper, Utah 84020
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.