Autism Treatment Trials

The list below is of autism clinical trials currently taking place in the US and actively recruiting participants.

Please note that the studies listed on this page are not run or organised by the BRAIN Foundation and we are unable to reply to email enquiries about clinical trials. We attempt to give as much details as possible below, but if you have any further questions please contact the study organisers directly.

ML-004 in Adolescents and Adults with ASD

PROJECT AIMS: Phase 2 randomized, double blind, placebo-controlled trial to assess whether there is an impact of ML-004 compound on the core social communication deficits and on the associated features of irritability in ASD.
LOCATIONS: Various centers across US, Canada and Australia (click here for the list of locations)
AGES: 12 to 45
ADDITIONAL CRITERIA FOR INCLUSION: Age 12 to 45 at screening; Has a designated care/study partner who can reliably report on symptoms; Has a diagnosis of ASD; Full scale IQ (or equivalent) ≥70 score; Psychoactive medications and adjunctive therapies are stable for 4 weeks prior to screening; Must be able to swallow study medication
CONTACT: Contact: Kelly Amaguin +1 650-839-4388 or email kamaguin[AT]

The TAPESTRY study

PROJECT AIMS: To establish if AB-2004 can improve irritability in autism. AB-2004 is a therapeutic agent designed to selectively adsorb substances produced by bacteria in the gut and reduce their ability to enter the bloodstream and contribute to irritability. This study builds upon research that has shown a significant difference in the gut bacteria in autism compared to controls, as well as the link between gut bacteria and the brain which could influence behavioral characteristics, including irritability.
LOCATIONS: United States, Australia and New Zealand
AGES: 13 to 17
ADDITIONAL CRITERIA FOR INCLUSION: irritability + GI symptoms (constipation, diarrhea, or bloating)

JelikaLite - tPBM Treatment Trial Study

PROJECT AIMS: To examine effectiveness of a novel, non-invasive, light therapy device designed to improve language and behavior of children with ASD. A therapeutic wearable device combines non-invasive brain stimulation with infrared light, sensors and an AI personalization platform. The trial will include children between ages 2-10 with moderate to severe diagnosis of autism.
AGES: 2 to 10, with moderate to severe autism
ADDITIONAL CRITERIA FOR INCLUSION: Ability to attend clinical sessions in Brooklyn office, NY: having your child visit a doctor’s office for a period of approximately 30 minutes, twice a week, for a period of 10 weeks.
CONTACT: fill in this form to express interest in participation

GEMMA (Genome, Environment, Microbiome and Metabolome in Autism)

LEAD INVESTIGATOR/INSTITUTION: Dr. Alessio Fasano, MassGeneral Hospital for Children
PROJECT AIMS: to learn more about the many factors that contribute to the development of autism. This long-term, multicenter study follows infants who are genetically at-risk of developing ASD for their first three years of life with visits that can be completed at their local pediatrician’s office. Infants can even be enrolled before birth!
AGES: 0-6 months
INCLUSIONS/EXCLUSIONS: any infant 0-6 months of of age and that has a sibling with ASD is eligible for this study
CONTACT: mghgemma (at)

Are you an investigator needing help recruiting participants?

If you run a clinical trial for autism or any related neurodevelopmental disorders and would like your study listed here, please reach out to us on info [AT]

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