EFFECT OF INTRANASAL OXYTOCIN ON DYSPHAGIA IN CHILDREN AND ADOLESCENTS WITH PRADER WILLI SYNDROME

Phase 1

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

• Registration Number: EUCTR2021-000094-91-FR
• Lead Sponsor: Toulouse University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-01
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1.Male or female patients aged between 2 and 17,5 years.
2.Genetically confirmed diagnosis of PWS.
3.Parents (or legal representative) have signed the informed consent form and are willing to comply with all study procedures.
Are the trial subjects under 18? yes
Number of subjects for this age range: 36
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

1. A history of hypersensitivity to the study drug or drugs with similar chemical structures, to excipients of the product, or to latex;
2.Intolerance of intranasal administrations (including when due to a major behavioural problem);
3.Hyponatremia (clinically relevant at the discretion of the investigator);
4.Hypokalaemia (clinically relevant at the discretion of the investigator);
5.Prolongation of the QT interval and/or family history of prolongation of the QT interval;
6.Concomitant treatment prolonging the QT interval;
7.History of abnormal electrocardiogram (ECG) (validated by a cardiologist);
8.Pregnant girls; (for girls aged 14 years of above who do not have contraception and are sexually active, a negative pregnancy test will be required)
9.Patient with clinical signs in the context of contact with SARs-COV2 infected person
10.Patient included in another study protocol on a medicinal product within the last 6 months
11.Administrative problems:

Study & Design

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