Oxytocin intranasal administrations in children with Prader-Willi syndrome aged from 3 to 12 years.

Phase 1

• Conditions: Prader-Willi Syndrom; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2016-003273-18-FR
• Lead Sponsor: niversity Hospital of Toulouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-22
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

patient with a complete genetic diagnosis of PWS
patient aged from 3 to 12 years
patient treated by growth hormone for at least 1 year
patient naïve for OXT for at least 5 years

Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

patient who do not accept intranasal administrations (major behavioural trouble)
patient with hepatic insufficiency : serum transaminases higher than 3 times normal values for age
patient with renal insufficiency : serum creatinine higher than 3 times normal values for age
patient with an antecedent of abnormal electrocardiogram
patient with arterial hypertension or hypotension
patient with type 1 or 2 diabetes

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Study the effect of the administration intranasale of oxytocin (OXT) during 12 weeks on the behavior disorders by comparison with a placebo;Secondary Objective: Study the effect of the intranasal administration of OXT during 12 weeks by comparison with a placebo on :<br>The hyperphagia<br>The social skills<br>The auto and hetero aggressives behaviors <br>The psychopathology<br>the global clinical state <br>The evolution of the circulating rates of acyl and non acyl ghreline;Primary end point(s): evolution of behavioural troubles evaluated by the global score of CBCL questionnaire after 12 weeks of OXT or placebo treatment;Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 12 weeks and at inclusion;Secondary end point(s): Evaluation of hyperphagia evaluated by Dykens questionnaire <br>- social skills by PSA questionnaire for children aged from 3 to 6 years and by SRS questionnaire for children aged from 7 to 12 years.<br>- auto- and hetero-aggressive behavior by ECAA questionnaire<br>- psychopatholy of patient evaluated by the 3 following subscores of CBCL questionnaire <br>- global clinical status of patient evaluated by a specific PWS grid <br>- acyl and desacyl grelin plasma levels<br>For patients aged from 7 to 12 years at inclusion: <br>- attentional abilities by ANT (Attention Network Test) <br>- metabolic brain resting state BY mri<br>