ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)

Running, not enrolling · Phase 2

Conditions studied: Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT05889273

Run by

MapLight Therapeutics

People needed

120

Starts

2023-06-01

Expected to finish

2027-12-01

Last updated by the study team

2026-07-20

Who can join

Age: 12 and older, up to 46. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 to screening
• Must be able to swallow study medication

You may not qualify if…

• Has Rett syndrome or Child Disintegrative Disorder
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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