Intranasal administration of oxytocin in children and young-adults with Prader-Willi syndrome

Phase 1

• Conditions: Prader-Willi syndrome; MedDRA version: 17.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2013-004134-15-NL
• Lead Sponsor: Dutch Growth Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-20
• Last Update Posted: 22 May 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 25 years

For fMRI: age > 6 years.

Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

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