Intranasal Oxytocin for Infants With Prader-Willi Syndrome

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Prader-Willi Syndrome

In brief

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.

Key facts

Study ID

NCT03245762

Run by

University of Florida

People needed

15

Starts

2017-08-01

Expected to finish

2018-01-04

Last updated by the study team

2020-03-26

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals with genetically confirmed PWS who are in nutritional phase 1a, as determined by PI
• Physical exam and laboratory results that are within the normal range.
• Presence of a parent/caregiver/guardian that is able to consent for their participation.

You may not qualify if…

• Exposure to any investigational agent in the 30 days prior to randomization.
• Prior chronic treatment with oxytocin.
• A medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger the subject's well-being.

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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