ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)
NCT ID: NCT05081245
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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ACTIVE_NOT_RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2022-09-13
2026-11-30
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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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
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.
ML-004 Placebo
Matched placebo oral tablets will consist of same excipients as the investigational drug but without any ML-004. Placebo taken orally once daily to match tablet number of ML-004 dose levels for 12 mg (1 tablet), 24 mg (1 tablet), 48 mg (2 tablets), and 72 mg (3 tablets).
ML-004 Placebo
Participants will receive matching placebo once daily.
Interventions
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ML-004 (IR)/(ER) tablet
Participants will receive ML-004 once daily.
ML-004 Placebo
Participants will receive matching placebo once daily.
Eligibility Criteria
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Inclusion Criteria
* 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 through 34 kg/m², inclusive
* Full scale IQ (or equivalent) ≥55 score, with adequate verbal fluency, as determined by the Principal Investigator.
* Psychoactive medications and adjunctive therapies are stable for 4 weeks prior to screening
* Must be able to swallow study medication
Exclusion Criteria
* Has participated in any other study and received any other investigational medication (other than COVID-19 vaccination) or device within 60 days prior to screening
* History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening
* History of suicidal ideation or behavior in the past 12 months, or a positive response to C-SSRS questions 4 and/or 5
* Systolic blood pressure ≥140 mmHg (if adult) or \>135 mmHg (if adolescent), or diastolic blood pressure ≥90 (if adult) or \>85 mmHg (if adolescent), or a clinical history of uncontrolled or severe hypertension
* If female, is pregnant or lactating
12 Years
45 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 & 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
Countries
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Other Identifiers
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ML-004-002
Identifier Type: -
Identifier Source: org_study_id