🏛️ Verified NIH Record • Updated 2026-07-17
ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD) (NCT05889273)
An Open-label Extension Study to Investigate Safety and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).
🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: MapLight Therapeutics
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Harmonex Neuroscience Research — Dothan, Alabama
Age range: 12 Years to 46 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (21 Sites)
- Harmonex Neuroscience Research — Dothan, Alabama
- Southwest Autism Research and Resource Center — Phoenix, Arizona
- Cortica Healthcare — Glendale, California
- NRC Research Institute — Orange, California
- Cortica — San Rafael, California
- Yale Child Study Center — New Haven, Connecticut
- The Children's Research Institute — Washington D.C., District of Columbia
- Abba Medical Group — Miami, Florida
- APG Research, LLC — Orlando, Florida
- University of South Florida Psychiatry and Behavioral Neurosciences — Tampa, Florida
- Neurobehavioral Medicine Group — Bloomfield Hills, Michigan
- University of Missouri, Thompson Center for Autism & Neurodevelopment — Columbia, Missouri
- Nathan Kline Institute for Psychiatric Research — Orangeburg, New York
- Richmond Behavioral Associates — Staten Island, New York
- Suburban Research Associates — Media, Pennsylvania
- BioBehavioral Research of Austin — Austin, Texas
- Road Runner Research, Ltd. — San Antonio, Texas
- Family Psychiatry of The Woodlands — The Woodlands, Texas
- Brain and Mind Centre — Camperdown, New South Wales
- The Royal Children's Hospital, Murdoch Children's Research Institute — Parkville, Victoria
- Holland Bloorview Kids Rehabilitation Hospital — Toronto, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Autism Spectrum Disorder
- Improving the Part C Early Intervention Service Delivery System for Children With ASD — Chicago, Illinois
- Treatment to Improve Sleep in Caregivers With Insomnia and a Child With Autism — Philadelphia, Pennsylvania
- Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder — New Haven, Connecticut
- PRISM Intervention Study — Los Angeles, California
- MTT for Children With ASD Who Have Gastrointestinal Disorders — Tempe, Arizona
Explore by condition: All Autism Spectrum Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.