CompletedNot Applicable

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

France40 participantsStarted 2016-11-28

Plain-language 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.

Who can participate

Age range3 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patient with a complete genetic diagnosis of Prader-Willi syndrome * patient treated by growth hormone for at least 1 year * patient naïve for oxytocin for at least 5 years Exclusion Criteria: * patient who do not accept intranasal administrations (major behavioural trouble) * patient with hepatic insufficiency : serum transaminases (SGOT, SGPT) 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

What they're measuring

Evolution of behavioural troubles evaluated by the global score of Child Behavior Check List Questionnaire after 12 weeks of oxytocin/placebo treatment.

Timeframe: Week 12

Trial details

NCT IDNCT03114371

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01

View on ClinicalTrials.gov More Prader-Willi Syndrome trials