Aardvark Therapeutics recently launched HERO, a global Phase 3 clinical trial investigating ARD-101, an innovative, orally administered treatment designed to help reduce hyperphagia (excessive hunger) and food-seeking behaviors in individuals with Prader-Willi syndrome (PWS).
This randomized, double-blind, placebo-controlled trial is an important step toward identifying a potential new treatment option for the PWS community, and now, trial sites across the United States are actively enrolling participants.
Current HERO Trial Sites Now Enrolling:
Birmingham, Alabama
Children’s of Alabama
Contact: Hussein Abdul-Latif, MD / Tushima Reeves
Phone: (205) 638-9173
Email: tfails@uabmc.edu
Wilmington, Delaware
Nemours Children Clinic Wilmington
Contact: Aaron Chidekel, MD / Kerry Smallacombe, DO
Phone: (302) 559-0247
Email: kerry.smallacombe@nemours.org
Mineola, New York
NYU Langone Children’s Ambulatory Care Center
Contact: Jorge Mejia-Corletto, MD
Phone: (516) 663-4600
Email: jorge.mejia-corletto@nyulangone.org
Nashville, Tennessee
Vanderbilt University Medical Center
Contact: Ashley Shoemaker, MD / Celia Núñez
Phone: (615) 322-4559
Email: celia.m.nunez@vumc.org
Weslaco, Texas
Texas Valley Clinical Research, LLC
Contact: Eduardo Luna, MD / Preston Hale
Phone: (956) 554-4003
Email: hale.rn@tvcrtrials.com
Additional trial sites are expected to begin enrolling soon. PWSA | USA will continue to share trial sites as they become available. Please visit www.heroforpws.com or clinicaltrials.gov for the most up-to-date list of participating locations.
About the HERO Study
The HERO trial is exploring whether ARD-101 can effectively reduce symptoms of hyperphagia in individuals with PWS. Participants will be randomly assigned to receive either the active medication or a placebo. To help ensure objective results, neither participants nor the study team will know which treatment is being administered.
Key Eligibility Criteria:
- – Age 13 or older
- – Confirmed diagnosis of Prader-Willi syndrome
- – A single caregiver who can support clinic attendance, complete questionnaires and diaries, and monitor changes in behavior and food intake
What to Expect:
- – Oral study drug taken twice daily for 12 weeks
- – 4 in-person clinic visits and 3 telehealth check-ins
- – Travel and lodging support for the participant and caregiver
- – No fasting required
- – Optional follow-up study with guaranteed access to the active study drug for those who complete the initial trial
If your loved one is living with PWS and meets the study criteria, participating in this trial could play a meaningful role in advancing potential treatment options for the entire community.
Visit www.heroforpws.com to learn more or find a trial site near you.
Jennifer Bolander has been serving as a Special Education Specialist for PWSA (USA) since October of 2015. She is a graduate of John Carroll University and lives in Ohio with her husband Brad and daughters Kate (17), and Sophia (13) who was born with PWS.
Perry A. Zirkel has written more than 1,500 publications on various aspects of school law, with an emphasis on legal issues in special education. He writes a regular column for NAESP’s Principal magazine and NASP’s Communiqué newsletter, and he did so previously for Phi Delta Kappan and Teaching Exceptional Children.
Evan has worked with the Prader-Willi Syndrome Association (USA) since 2007 primarily as a Crisis Intervention and Family Support Counselor. Evans works with parents and schools to foster strong collaborative relationships and appropriate educational environments for students with PWS.
Dr. Amy McTighe is the PWS Program Manager and Inpatient Teacher at the Center for Prader-Willi Syndrome at the Children’s Institute of Pittsburgh. She graduated from Duquesne University receiving her Bachelor’s and Master’s degree in Education with a focus on elementary education, special education, and language arts.
Staci Zimmerman works for Prader-Willi Syndrome Association of Colorado as an Individualized Education Program (IEP) consultant. Staci collaborates with the PWS multi-disciplinary clinic at the Children’s Hospital in Denver supporting families and school districts around the United States with their child’s Individual Educational Plan.
Founded in 2001, SDLC is a non-profit legal services organization dedicated to protecting and advancing the legal rights of people with disabilities throughout the South. It partners with the Southern Poverty Law Center, Protection and Advocacy (P&A) programs, Legal Services Corporations (LSC) and disability organizations on major, systemic disability rights issues involving the Individuals with Disabilities Education Act (IDEA), Americans with Disabilities Act (ADA), and the federal Medicaid Act. Recently in November 2014, Jim retired.