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

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.

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.

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.

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