Effect of Intranasal Oxytocin on Dysphagia in Children and Adolescents With Prader-Willi Syndrome

What Was Tested

This registered phase 2, phase 3 trial tested Oxytocin.

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.

It had two arms (groups): OXYTOCIN nasal spray (experimental) and PLACEBO (placebo comparator).

Intranasal administration of Oxytocin.

Intranasal administration of placebo.

The registry classes the interventions as drug.

Who Took Part

The registry lists 25 actual participants took part.

It was open to people of any sex aged from 2 years up to 17 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female patients between 2 years and 17 years and 5 months at inclusion. Genetically confirmed diagnosis of PWS. Parents (or legal representative) have signed the informed consent form and are willing to comply with all study procedures.

The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: A history of hypersensitivity to the study drug or drugs with similar chemical structures, to excipients of the product, or to latex;; intolerance of intranasal administrations (including when due to a major behavioural problem);; hyponatremia (clinically relevant at the discretion of the investigator);.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Oxytocin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2022-04-05 with completion listed for 2023-04-11.

It ran at 4 sites in France (4).

Its stated primary purpose is other.

What Was Measured

Primary outcome: videofluoroscopic swallowing study (VFSS) score change (time frame: after 12 weeks oxytocin (OT) / placebo (at V2)).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Oxytocin in 25 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.