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A Phase 3, Multicenter, Open-Label Extension Study to Assess the Safety and Efficacy of ARD-101 in Patients With Prader-Willi Syndrome
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.
Age
13 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
July 23, 2024
Primary Completion Date
March 1, 2027
Completion Date
April 1, 2027
Last Updated
March 19, 2026
90
ESTIMATED participants
ARD-101
DRUG
Lead Sponsor
Aardvark Therapeutics, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04463316