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Now serving Temecula/Murietta/Menifee areas of Southern California.

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: 

  • 18-45 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

Maplight boy with brain

What is Involved? 

  • Testing: ASD assessment, IQ assessment, psychiatric questionnaires, and medical evaluations 

  • Frequency of visits: 10 visits (every 2-3 weeks) over 4 months 

  • Costs: No costs will be charged for any of the study procedures.  

  • Payment: In return for the time, effort, and travel expenses, adults with their study partners will be compensated $200 per visit 

Location and Contact Information 

Maplight study state map