Update: This Phase I study has been completed – we look forward to publication of the results, and the next steps of oxytocin development.
Individuals with Prader-Willi syndrome (PWS) have been found to have a deficit of oxytocin-producing neurons and decreased oxytocin receptor gene function. The purpose of this Phase 1 study is to determine if oxytocin (OT) administration will improve some of the aspects of Prader-Willi syndrome that are particularly troublesome for children and their families (i.e. the insatiable appetite and social behaviors).
The research questions are:
- Does intranasal oxytocin cause any side effects in children with PWS?
- Does intranasal oxytocin administration alter appetite or behaviors in PWS?
There are (3) study sites including University of Florida, University of California Irvine, and Kansas University Medical Center. Participants must be between the ages of 5-11, in nutritional phase 2b or 3, and currently taking growth hormone.
For more study details, please visit the clinicaltrials page here.