Clinical Research Directory
Browse clinical research sites, groups, and studies.
The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial
Sponsor: Aardvark Therapeutics, Inc.
Summary
The goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome (PWS) when used in a long term setting. It will also teach us about the safety of ARD-101. The main questions it aims to answer are: What medical problems do participants have when taking ARD-101 in a long term setting Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)? Eligible participants will: Have completed treatment on the AVK-101-301 study through Week 12/End of Treatment Take ARD-101 every day for up to 12 months. Visit the clinic at Months 1, 3, 6 and 12 during dosing and then have tele-visits at Week 2, Months 3 and 9, then 4 weeks after stopping the ARD-101. Patients/Caregivers will keep a daily diary.
Official title: A Phase 3, Multicenter, Open-Label Extension Study to Assess the Safety and Efficacy of ARD-101 in Patients With Prader-Willi Syndrome
Key Details
Gender
All
Age Range
13 Years - Any
Study Type
INTERVENTIONAL
Enrollment
19
Start Date
2024-07-23
Completion Date
2026-04-15
Last Updated
2026-06-30
Healthy Volunteers
No
Interventions
ARD-101
200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 50 weeks
Locations (30)
Children's of Alabama
Birmingham, Alabama, United States
Children's Hospital of Orange Country
Orange, California, United States
Stanford Children's Health Specialty Services
Palo Alto, California, United States
Rady Children's Hospital
San Diego, California, United States
Children's Hospital Colorado
Denver, Colorado, United States
Nemours Children's Clinic Wilmington
Wilmington, Delaware, United States
UF Shands Children's Hospital
Gainesville, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States
Maimonides Medical Center
Brooklyn, New York, United States
NYU Langone Children's Ambulatory Care Center
Mineola, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Alberta Children's Hospital Research Institute
Calgary, Alberta, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
Children's Hospital at London Health Sciences Centre
London, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Inha University Hospital
Incheon, South Korea
Samsung Medical Center
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Fulborn Hospital
Cambridge, United Kingdom
Royal Hospital for Children (Glasgow) - PPDS - PIN
Glasgow, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
The Royal London Hospital
London, United Kingdom