IRIS Clinical Trial for Autism

Study Overview

• Study directors: Elysa Marco, MD and Kevin Shapiro, MD 

• Recruiting: Yes 

• Study 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) 

• Condition: Autism Spectrum Disorder 

• Purpose: The purpose of this study is to find out whether ML-004, an extended-release version of zolmitriptan, can support with sociability and emotional regulation in adults with ASD. 

Eligibility

Inclusion criteria: 

• 12 - 17 years old 

• Diagnosed (or suspected) Autism Spectrum Disorder 

• Seeking to strengthen social engagement skills 

• Uses fluent spoken language 

• Has a designated study partner who is also willing to participate 

Exclusion criteria: 

• Seizures requiring current medication management 

• History of migraines 

• Unable to swallow tablets 

• Unstable medical or psychiatric illness 

• Currently using certain medications for ASD – contact our study team to discuss