Intranasal administration of oxytocin in children with Prader-Willi Syndrome

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Hormonal diseases [C19]; MedDRA version: 19.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Prader-Willi syndrome

• Registration Number: EUCTR2016-003820-22-NL
• Lead Sponsor: Dutch Growth Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-12
• Last Update Posted: 23 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Genetically confirmed diagnosis of Prader-Willi syndrome
- Age between 3 and 16 years
- Currently on growth hormone treatment for at least 1 year
- Behavioural problems (for example temper tantrums and autistic behaviour) and/or be in nutritional phase 2b or 3 according to Miller.

For fMRI: age > 6 years
Are the trial subjects under 18? yes
Number of subjects for this age range: 44
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

- Severe psychiatric problems
- Non-cooperatieve behaviour
- Allergic reactions or hypersensitivity for oxytocin
- Serious illness
- Cardiac abnormalities
- Extremely low dietary intake or less than minimal required intake acoording to WHO
- Medication to reduce weight (fat)

Study & Design

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