Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Prader-Willi Syndrome
Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
Summary
This study is a phase 2 randomized double blind 8-week treatment trial of intranasal OXT vs.
placebo in 50 subjects aged 5 to 17 years with PWS in order to assess IN-OXT's affect on
measurements of (1) eating behaviors (2) repetitive behaviors (3) weight and body composition
(4) quality of life (5) salivary OXT and hormone levels (including ghrelin, pancreatic
polypeptide, peptide YY, GLP-1, insulin, glucagon, testosterone, and estrogen). If superior
to placebo, this data will add to the current knowledge that OXT is an effective treatment
for hyperphagia as well as other symptoms of PWS.
Funding Source- FDA OOPD