Oxytocin Treatment in Neonates and Infants Aged From 0 to 3 Months With Prader-Willi Syndrome : a Study of Safety and Efficacy on Oral and Social Skills and Feeding Behavior of Intranasal Administration of Oxytocin vs Placebo

University Hospital, Toulouse7 sites in 3 countries52 target enrollmentMarch 10, 2020

ConditionsPrader-Willi Syndrome

InterventionsOT Placebo comparator

DrugsOT Placebo comparator

Overview

Phase: Phase 3
Intervention: OT
Conditions: Prader-Willi Syndrome
Sponsor: University Hospital, Toulouse
Enrollment: 52
Locations: 7
Primary Endpoint: Neonatal Oral-Motor Assessment Scale (NOMAS) scale
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Prospective, randomized, placebo-controlled, double-blind part of the phase III trial to assess the safety and efficacy of 4 weeks oxytocin (OT) administration on oral and social skills in neonates/infants with Prader-Willi Syndrome (PWS) aged less than 3 months at inclusion. Phase III clinical trial.

Registry

clinicaltrials.gov

Start Date

March 10, 2020

End Date

March 14, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Toulouse

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female neonate or infant, with PWS genetically confirmed.
•Age \<92 days (plus a tolerance of up to 8 days maximum) (for preterm infants, born before 37 weeks amenorrhea, corrected age will be applied).
•Signed informed consent obtained from the parents/holders of parental authority.
•Parents willing and able to comply with all study procedures.

Exclusion Criteria

•Neonate or infant currently admitted to the emergency care unit for ongoing life-threatening comorbidities like severe respiratory, cardiovascular or neurological abnormalities.
•Neonate or infant with prolongation of the QT interval.
•Neonate or infant without medical insurance.
•Neonate or infant with hypersensitivity to oxytocin or excipients of the product.
•Neonate or infant with concomitant treatment prolonging QT interval
•Neonate or infant with family history of genetic pathology causing QT interval prolongation.
•Neonate or infant with hypokalemia (clinically relevant at the discretion of the doctor).
•Neonate or infant participating simultaneously in another interventional study.
•Neonates or infants whose parents' situations may jeopardize the interpretation of the results.
•Neonates or infants whose parents' refuse video recording, required to respond to the primary objective of the study.