Status:
COMPLETED
Intranasal Oxytocin for Infants With Prader-Willi Syndrome
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Prader-Willi Syndrome Association
Conditions:
Prader-Willi Syndrome
Eligibility:
All Genders
1-6 years
Phase:
PHASE1
PHASE2
Brief 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 Synd...
Detailed Description
The overall objective of this Phase 2 trial is to compare the change from baseline to morning of day 6 of Internasal Oxytocin (IN-OT) on suck and swallow competency in infants/children with Prader-Wil...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03245762
Start Date
August 1 2017
End Date
January 4 2018
Last Update
March 26 2020
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610