Current Research Studies
A Phase 3, Multicenter, Open-Label Extension Study to Assess the Safety and Efficacy of ARD-101 in Patients with Prader-Willi Syndrome
AVK-101-302
What is the goal of the study?
This is a Phase 3, multicenter, Open-label extension (OLE) study of ARD-101 for the treatment of hyperphagia in patients with PWS. Patients who have completed Study AVK-101-301 and meet the entry criteria will be invited to enroll into this OLE study. The primary safety objective is the following: • Evaluate the long-term safety and tolerability of ARD-101. The primary efficacy objective is the following: • Evaluate the effect of ARD-101 on hyperphagia-related behavior in patients with PWS as measured by total score of the 9-item Hyperphagia Questionnaire for Clinical Trials (9-item HQ-CT).
Who can participate in the study?
Please contact the study team listed below to learn more.