New drug ML-004 moves to safety testing in autism patients
NCT ID NCT05889273
First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times
Summary
This study is testing the safety of an experimental drug called ML-004 in 120 adolescents and adults with autism spectrum disorder who have already completed a previous study. Participants will take ML-004 once daily, and researchers will monitor for side effects. The goal is to see if the drug is safe enough for further testing.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- ML-004 tablet
- What this could lead to
- If it works, this could point toward a treatment to help manage core symptoms of autism spectrum disorder.
- What could go wrong
- This is an early-phase safety study, so it is not designed to prove effectiveness. The drug may cause side effects or not work better than a placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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APG Research, LLC
Orlando, Florida, 32803, United States
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Abba Medical Group
Miami, Florida, 33176, United States
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BioBehavioral Research of Austin
Austin, Texas, 78759, United States
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Brain and Mind Centre
Camperdown, New South Wales, 2050, Australia
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Cortica
San Rafael, California, 94903, United States
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Cortica Healthcare
Glendale, California, 91203, United States
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Family Psychiatry of The Woodlands
The Woodlands, Texas, 77381, United States
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Harmonex Neuroscience Research
Dothan, Alabama, 36303, United States
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Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G 1R8, Canada
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NRC Research Institute
Orange, California, 92868, United States
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Nathan Kline Institute for Psychiatric Research
Orangeburg, New York, 10962, United States
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Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, 48302, United States
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Richmond Behavioral Associates
Staten Island, New York, 10314, United States
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Road Runner Research, Ltd.
San Antonio, Texas, 78249, United States
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Southwest Autism Research and Resource Center
Phoenix, Arizona, 85006, United States
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Suburban Research Associates
Media, Pennsylvania, 19063, United States
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The Children's Research Institute
Washington D.C., District of Columbia, 20010, United States
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The Royal Children's Hospital, Murdoch Children's Research Institute
Parkville, Victoria, 3052, Australia
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University of Missouri, Thompson Center for Autism & Neurodevelopment
Columbia, Missouri, 65211, United States
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University of South Florida Psychiatry and Behavioral Neurosciences
Tampa, Florida, 33613, United States
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Yale Child Study Center
New Haven, Connecticut, 06519, United States
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