A Phase 3, Multicenter, Open-Label Extension Study to Assess the Safety and Efficacy of ARD-101 in Patients With Prader-Willi Syndrome
Status: Recruiting
Location: See all (36) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Healthy Volunteers: f
View:
• Patients who have completed treatment on Aardvark Therapeutics clinical study AVK-101-301
Locations
United States
Alabama
Children's of Alabama
NOT_YET_RECRUITING
Birmingham
California
Stanford Children's Health Specialty Services
NOT_YET_RECRUITING
Palo Alto
Rady Children's Hospital
NOT_YET_RECRUITING
San Diego
Colorado
Children's Hospital Colorado
NOT_YET_RECRUITING
Denver
Delaware
Nemours Children's Clinic Wilmington
NOT_YET_RECRUITING
Wilmington
Florida
UF Shands Children's Hospital
NOT_YET_RECRUITING
Gainesville
Georgia
Emory University School of Medicine
NOT_YET_RECRUITING
Atlanta
Minnesota
University of Minnesota Masonic Children's Hospital