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

• Register: EUCTR
• Last refreshed on: 22 May 2017
• Main ID: EUCTR2013-004134-15-NL
• Date of registration: 20/03/2014
• Prospective Registration: Yes
• Primary sponsor: Dutch Growth Research Foundation
• Public title: Intranasal administration of oxytocin in children and young-adults with Prader-Willi syndrome
• Scientific title: Intranasal administration of oxytocin in children and young adults with Prader-Willi Syndrome. A randomized, double-blind, placebo-controlled trial. Effects on satiety and food intake, and social behaviour. - Intranasal administration of oxytocin in PWS
• Date of first enrolment: 15/07/2014
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004134-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Netherlands

Contacts

• Name: Project leader Prader-Willi Study
• Affiliation: Dutch Growth Research Foundation

• Name: Project leader Prader-Willi Study
• Affiliation: Dutch Growth Research Foundation

Key inclusion & exclusion criteria

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)



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Prader-Willi syndrome
MedDRA version: 17.0 Level: PT Classification code 10036476 Term: Prader-Willi syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders

Intervention(s)

Trade Name: Syntocinon nasal spray
Product Name: oxytocin
Product Code: oxytocin
Pharmaceutical Form: Nasal spray
Pharmaceutical form of the placebo: Nasal spray
Route of administration of the placebo: Intranasal use (Noncurrent)

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Day 1: Baseline assessments in the hospital, first administration of oxytocin/placebo followed by observation period and instruction of administration.
Day 2-28: Administration of oxytocin/placebo every morning and evening at home.
Day 29: Hospital visit and assessments after use of oxytocin/placebo for 4 weeks. First administration of the other drug (oxytocin/placebo) followed by observation period.
Day 30-56: Administration of oxytocin/placebo every morning and evening at home.
Day 57: Hospital visit and assessments after use of the other drug (oxytocin/placebo) for 4 weeks.

Primary end point(s): Change 4 weeks oxytocin versus 4 week placebo on:
- Body composition (Anthropometric measurements, BMI and DXA-scan)
- Eating behaviour (Dykens hyperphagia questionnaire and questionnaire about behaviour)
- Social behaviour (Questionnaire about behaviour for parents and Theory of Mind test)

Secondary Objective: To assess oxytocin levels in blood and saliva samples before, during and after oxytocin treatment compared with placebo.
To evaluate the effect of intranasal oxytocin administration compared with placebo in relation to fMRI (BOLD response) in children >6 years.

Main Objective: To evaluate the effects of intranasal oxytocin compared to placebo administration on appetite, satiety and food intake and on social behavior, BMI, body composition, IGF-I levels and genetic differences (deletion / mUPD).

Secondary Outcome(s)

Secondary end point(s): - Laboratory parameter (oxytocin in saliva and blood)
- Safety parameters (laboratory parameters and medical assessments).
- fMRI (BOLD responses) in children >6 years

Timepoint(s) of evaluation of this end point: Day 1: Baseline assessments in the hospital, first administration of oxytocin/placebo followed by observation period and instruction of administration.
Day 2-28: Administration of oxytocin/placebo every morning and evening at home.
Day 29: Hospital visit and assessments after use of oxytocin/placebo for 4 weeks. First administration of the other drug (oxytocin/placebo) followed by observation period.
Day 30-56: Administration of oxytocin/placebo every morning and evening at home.
Day 57: Hospital visit and assessments after use of the other drug (oxytocin/placebo) for 4 weeks.

Secondary ID(s)

2013-OX

Source(s) of Monetary Support

Dutch Growth Research Foundation