At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 15 enrolled
Drug / intervention
Oxytocin +1 moredrug
Likely dose
Oxytocin 4 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intranasal Oxytocin for Treatment of Infants and Children With Prader-Willi Syndrome in Nutritional Phase 1a - Phase 2 Study
In Brief
A Phase 2 clinical trial evaluating Oxytocin and Placebo for Prader-Willi Syndrome. Completed, enrolled 15 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrader-Willi Syndrome
CountriesUnited States
CollaboratorsPrader-Willi Syndrome Association
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartAug 2017
First PostedAug 2017
Primary CompletionJan 2018
TodayJul 2026
First PostedAug 10, 2017
Enrollment StartAug 1, 2017
Primary CompletionJan 4, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.9 years ago
Interventions
Oxytocindrug
4 IU/day of oxytocin administered via nasal spray device each morning.
Placebodrug
4 IU/day of placebo administered via nasal spray device each morning