Intranasal Oxytocin for Infants With Prader-Willi Syndrome

• Status: Completed
• Trial end date: 2018-01-04
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the change in suck and swallow competency from baseline to morning of day 6 with intranasal oxytocin spray vs placebo in infants/children with Prader-Willi Syndrome who are in nutritional phase 1a. Videofluoroscopic swallow studies will be performed on treatment day 1 and on the day following treatment morning of day 6.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: Prader-Willi Syndrome Association
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

1. Individuals with genetically confirmed PWS who are in nutritional phase 1a, as determined by PI

2. Physical exam and laboratory results that are within the normal range.

3. Presence of a parent/caregiver/guardian that is able to consent for their participation.

Exclusion Criteria:

1. Exposure to any investigational agent in the 30 days prior to randomization.

2. Prior chronic treatment with oxytocin.

3. A medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger the subject's well-being.