ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)
NCT ID: NCT05889273
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE2
120 participants
INTERVENTIONAL
2023-06-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ML-004 (IR)/(ER) tablet
ML-004 is a bilayer immediate-release (IR)/extended-release (ER, gastroretentive) oral tablet formulation. ML-004 is taken orally once daily and provided as a tablet in two dose strengths of 12 mg (3 mg IR/9 mg ER) and 24 mg tablet (6 mg IR/18 mg ER). Dose levels for this study are 12 mg (provided as one 12 mg tablet), 24 mg (one 24 mg tablet), 48 mg (two 24 mg tablets), and 72 mg (three 24 mg tablets).
ML-004 (IR)/(ER) tablet
Participants will receive ML-004 once daily.
Interventions
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ML-004 (IR)/(ER) tablet
Participants will receive ML-004 once daily.
Eligibility Criteria
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Inclusion Criteria
* 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 to screening
* Must be able to swallow study medication
Exclusion Criteria
* History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening
* Has a positive response to C-SSRS questions 4 and/or 5, or is a significant risk for suicidal behavior
* Has a clinical history of uncontrolled or severe hypertension
* If female, is pregnant or lactating
12 Years
46 Years
ALL
No
Sponsors
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MapLight Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
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
Countries
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Related Links
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Other Identifiers
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ML-004-003
Identifier Type: -
Identifier Source: org_study_id