Effect of Intranasal Oxytocin on Dysphagia in Children and Adolescents With Prader-Willi Syndrome

Inclusion criteria

• Male or female patients between 2 years and 17 years and 5 months at inclusion.
• Genetically confirmed diagnosis of PWS.
• Parents (or legal representative) have signed the informed consent form and are willing to comply with all study procedures.

Exclusion criteria

• A history of hypersensitivity to the study drug or drugs with similar chemical structures, to excipients of the product, or to latex;
• Intolerance of intranasal administrations (including when due to a major behavioural problem);
• Hyponatremia (clinically relevant at the discretion of the investigator);
• Hypokalaemia (clinically relevant at the discretion of the investigator);
• Prolongation of the QT interval and/or family history of prolongation of the QT interval;
• Concomitant treatment prolonging the QT interval;
• Start of growth hormone (GH) treatment within the last 4 weeks before inclusion;
• History of abnormal electrocardiogram (ECG) (validated by a cardiologist);
• Pregnant girls; (for girls with childbearing potential who do not have contraception and are sexually active, a negative pregnancy test will be required)
• Patient with clinical signs in the context of contact with COVID-19 infected person.
• Patient included in another study protocol on a medicinal product within the last 6 months;
• Administrative problems:

• Inability to give parents (or legal representatives) expert medical information;
• No coverage by a social security regime.