Oxytocin Trial in Prader-Willi Syndrome

Prader Willi Syndrome Clinical Trial

Official title: Oxytocin Trial in Prader-Willi Syndrome

Status Completed

Clinical Trial Summary

Individuals with Prader-Willi syndrome (PWS) have been found to have a deficit of oxytocin-producing neurons and decreased oxytocin receptor gene function, so the purpose of this 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 (the insatiable appetite and social behaviors).

The research questions are:

1. Does intranasal oxytocin cause any side effects in children with PWS?

2. Does intranasal oxytocin administration alter appetite or behaviors in PWS?

Clinical Trial Description

This study is to investigate if intranasal oxytocin will improve hyperphagia, social skills, and behaviors in subjects with Prader-Willi syndrome. This will be a randomized placebo controlled pilot study. The primary outcome measure is to determine if intranasal administration of oxytocin will cause any adverse events in subjects with Prader-Willi syndrome. Secondarily, the investigators will also perform evaluations to determine if intranasal oxytocin has any effect on social skills, behaviors, or appetite in children with Prader-Willi syndrome. ;

Related Conditions & MeSH terms

• Hyperphagia
• Prader Willi Syndrome
• Prader-Willi Syndrome
• Syndrome

• NCT number: NCT02013258
• Study type: Interventional
• Source: University of Florida
• Status: Completed
• Phase: Phase 1
• Start date: March 2015
• Completion date: August 2015