ML-004 for Adolescents and Adults With ASD

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The purpose of this study is to test the safety of an investigational medicine called ML-004 and how it might affect communication, behavior, and other symptoms of autism spectrum disorder (ASD). This medication is investigational because it has not been approved by the FDA for the treatment of symptoms associated with autism. 

You may qualify if you: 

  • Are 12 to 25 years old
  • Have an autism diagnosis
  • Have a designated care/study partner able to attend every visit and answer questions about the participant. This person does not need to be the participant's parent or guardian. This person should have significant contact with them and can support them for the duration of the study.
  • Are able to swallow the study medication (tablet)

Who Do I Contact?

If you are interested in participating in the study or want to learn more please contact our study team at wozniaks1 [at] chop.edu or 267-600-5025.

Eligibility & Criteria

IRB #:
22-019675
Official Title:
A randomized, double-blind, parallel-group, placebo-controlled study to investigate the efficacy, safety, and tolerability of ML-004 in adolescents and adults with autism spectrum disorders (ASD)
Study Phase:
Phase II
Eligible Age Range:
12 - 25 Years
Gender:
All
Study Categories:

Visit Criteria

If you are eligible and agree to participate, you will be randomly assigned to receive either placebo (a pill with no medication in it) or the study medication. Participation will last approximately 25 weeks and involve 10 study visits and one phone call. You will need to take the study pill for approximately 17 weeks.

During these visits, participants will get blood, urine, and heart monitoring tests, and complete behavioral assessments and questionnaires. The duration of the visits may vary but are expected to last between 1 and 4 hours. 

Compensation will be provided to offset the costs of travel. You do not need to be a patient at CHOP to participate.