Autism Clinical Trial: Now Enrolling

IRIS

Does autism affect your life or the life of someone you love?

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MapLight Therapeutics is recruiting patients for IRIS, a Phase 2 clinical trial evaluating ML-004, the company’s lead clinical compound for patients with Autism Spectrum Disorder. The study will assess whether there is an impact of ML-004 treatment on the core social communication deficits and on the associated features of irritability in ASD. 

The randomized, double blind, placebo-controlled study will evaluate the efficacy and safety profile of ML-004 in up to 150 adults and adolescents with ASD. The study will be conducted in the United States, Australia, and Canada, and is fully funded by MapLight.

For more details on the study, and to contact participating sites near you, visit the study page at ClinicalTrials.gov.

About the clinical trial​

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The IRIS clinical trial is evaluating an oral investigational medication, ML-004, to see if it may help alleviate some of the symptoms that interfere with communication in those with autism spectrum disorder (ASD).

Participants may be able to take part in the clinical trial if they:

  • Are between the ages of 12 and 45 years old
  • Have a diagnosis of autism spectrum disorder (ASD)
  • Have a clinical trial/care partner* willing to assist during the trial

*The clinical trial/care partner is someone who lives with or has frequent contact with the clinical trial participant (parent, spouse, friend, etc.) and is willing and able to provide information about the participant and attend some trial visits. 

The clinical trial team will discuss additional eligibility criteria with you.

Study Sites Currently Screening and Enrolling Patients

Country State / City Physician Institute
United States Alabama / Dothan Nelson Handal-Thome, MD Harmonex Neuroscience Research
United States Arizona / Phoenix Christopher Smith, PhD Southwest Autism Research & Resource Center
United States California/Glendale Kevin Shapiro, MD, PhD Cortica Glendale
United States California/Orange Sailaja Golla, MD Thompson Autism and Neurodevelopmental Center - CHOC
United States California/Orange Tony Ortiz, PHD NRC Research Institute
United States California / San Francisco Robert Hendren, DO University of California, San Francisco
United States California/ San Rafael Elysa Marco, MD Cortica HealthCare, Department of Neurodevelopmental Medicine
United States Connecticut / New Haven Roger Jou MD, PhD Yale University
United States Washington DC Adelaide Robb, MD Children's National Health System
United States Florida / Orlando Morteza Nadjafi, MD APG Research, LLC
United States Florida / Tampa Daniel Fallon, MD USF Psychiatry and Behavioral Neurosciences
United States Massachusetts / Lexington Christopher Keary, MD Mass General Hospital's Lurie Center for Autism
United States Michigan / Bloomfield Hills Richard Jackson, MD Neurobehavioral Medicine Group
United States Missouri / Columbia Benjamin Black, MD U. Missouri, Thompson Center for Autism & Neurodevelopmental Disorders
United States New Jersey / Berlin Steve Glass, MD Hassman Research Institute
United States New Jersey / Neptune Stacy Doumas, MD Jersey Shore University Medical Center, a division of HMH hospital Corp.
United States New York / Orangeburg Russell Tobe, MD Nathan Kline Institute
United States New York / Staten Island Matt DiBuono, MD Richmond Behavioral Associates
United States New York / White Plains Jeremy Veenstra-VanderWeele, MD New York State Psychiatric Institute (NYSPI) Child & Adolescent Psychiatry
United States Ohio / Columbus Eugene Arnold, MD Ohio State University Nisonger Center
United States Pennsylvania / Media Shivkumar Hatti, MD Suburban Research Associates
United States Pennsylvania / Philadelphia Amanda Bennett, MD Children’s Hospital of Philadelphia The Robert’s Center for Pediatric Research
United States Texas / San Antonio Jerry Tomasovic, MD Road Runner Research, Ltd.
United States Utah / Draper Reid Robinson, MD Cedar Clinical Research
United States Washington / Seattle Gary Stobbe Seattle Children's Autism Center
Australia New South Wales / Camperdown Adam Gaustella, Prof Brain and Mind Centre
Australia Queensland / South Brisbane Helen Heussler, MBBS Children's Health Queensland Hospital and Health Service
Australia Queensland / South Brisbane Catherine Franklin, MBBS Mater Research
Australia South Australia / Adelaide Dylan Mordaunt, MBBS Flinders Medical Centre
Australia Victoria / Parkville David Amor, MBBS The Royal Children's Hospital, Murdoch Children's Research Institute
Canada British Columbia / Kelowna Euguene Okorie, MD OCT Research ULC
Canada Ontario / Toronto Danielle Baribeau, MD PhD Holland Bloorview Kids Rehabilitation Hospital/ Bloorview Research Institute-Autism Research Centre
Canada Ontario / London Rob Nicolson, MD London Health Sciences Centre/Lawson Health Research Institute
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