This phase 2B is designed to test the effectiveness of intranasal Oxytocin on Prader Willi Syndrome (PWS). This is a prospective, multicentre, randomised, double-blind, Phase 2B clinical study planned to include around 24 PWS patients aged 2-17 years and 5 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
25
Study treatment will be administered intranasally daily for 12 weeks. The daily dose of OT will be adapted according to age at the beginning of the study
Study treatment will be administered intranasally daily for 12 weeks.
Hopital Jeanne de Flandre
Lille, France
Hôpital Femme-Mère-enfant Groupement hospitalier Est
Lyon, France
Chu Rouen
Rouen, France
CHU de Toulouse
Toulouse, France
videofluoroscopic swallowing study (VFSS) score change
Percentage of patient with at least one VFSS subscore's change from baseline
Time frame: after 12 weeks oxytocin (OT) / placebo (at V2)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.