StudyFinder
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of ARD-101 for the Treatment of Hyperphagia in Patients with Prader-Willi Syndrome
Status: Recruiting
This study is for people who feel very hungry all the time, have trouble controlling eating (hyperphagia) and have Prader-Willi Syndrome (PWS). ARD-101 is being studied to see if it can help the body release certain gut hormones that may help reduce excessive hunger and food-seeking behaviors in people with PWS. The investigational treatment is a tablet taken by mouth and swallowed whole. The study will continue for up to 20 weeks (about 5 months).
Sex: Male or Female
Age Group: Up to 18 years old
Inclusion Criteria:
• at least 13 years of age
• confirmed diagnosis of Prader-Willi Syndrome (PWS)
• living in a stable care setting with the same caregiver(s) for at least 6 months and one designated caregiver is willing and able to adhere to study-related procedures and is willing to participate in all study visits and complete study-related questionnaires
• females must not be pregnant when starting the study and willing to use effective birth control for 90 days after the last dose of study drug
• males engaged in sexual relations with a female of childbearing potential must utilize a highly effective method of contraception until 90 days after the last dose of study drug
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:
• women who are pregnant or breastfeeding
• difficulty swallowing or inability to swallow oral medication
• significant medical or mental health diagnosis
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions:
Children's Health, Diabetes & Endocrine, Rare Diseases, Rare Diseases
Keywords:
PWS, Prader-Willi Syndrome
Study Contact: Kayla Arndt - arndt374@umn.edu
Principal Investigator: Brad Miller, MD, PhD
Phase: PHASE3
IRB Number: STUDY00024946
See this study on ClinicalTrials.gov