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Oxytocin Intranasal Administrations in Children With Prader-Willi Syndrome Aged From 3 to 12 Years — Oxyjeune  

Prader-Willi Syndrome Clinical Trial

Official title:
Effects of Intranasal Administrations of Oxytocin on Behavioural Troubles, Hyperphagia and Social Skills in Children With Prader-Willi Syndrome Aged From 3 to 12 Years.

Clinical Trial Summary

Positive results in preclinical and clinical studies in adults and infants with Prader-Willi syndrome lead investigators to set up a new study in children with Prader-Willi syndrome. The objective of this study is to document effects of oxytocin intranasal administrations on behavioural troubles in children with Prader-Willi syndrome aged from 3 to 12 years.

Clinical Trial Description

Two groups of patients will be constituted according to their age; "Group 1" children aged from 3 to 6 years (n = 20) and "Group 2" children aged from 7 to 12 years (n = 20). Within each group, subjects will be randomized to receive either oxytocin or placebo for 12 consecutive weeks. A second period of 12 consecutive oxytocin treatment weeks will then be performed for all patients, followed by a 4-week observation period to document effects after discontinuation of treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03114371
Study type Interventional
Source University Hospital, Toulouse
Contact
Status Completed
Phase N/A
Start date November 28, 2016
Completion date January 11, 2019
View Details
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