Status:
COMPLETED
Effect of Intranasal Oxytocin on Dysphagia in Children and Adolescents With Prader-Willi Syndrome
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Prader-Willi Syndrome
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
PHASE3
Brief Summary
This phase 2B is designed to test the effectiveness of intranasal Oxytocin on Prader Willi Syndrome (PWS). This is a prospective, multicentre, randomised, double-blind, Phase 2B clinical study planne...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05298085
Start Date
April 5 2022
End Date
April 11 2023
Last Update
June 1 2023
Active Locations (4)
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1
Hopital Jeanne de Flandre
Lille, France
2
Hôpital Femme-Mère-enfant Groupement hospitalier Est
Lyon, France
3
Chu Rouen
Rouen, France
4
CHU de Toulouse
Toulouse, France