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

• Status: Completed
• Trial end date: 2019-01-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Oxytocin

Criteria

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