Phase 2
N=15
Intranasal Oxytocin for Infants With Prader-Willi Syndrome
Prader-Willi Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03245762 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1a — 8; 4; 1; 1 Participants — p=0.930
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxytocin (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1a |
8; 4; 1; 1; 1; 0 | 0.930 |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03245762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.