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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004134-15-NL

Enrollment

Unknown

Registered

2014-03-20

Start date

2014-07-15

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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)

Design outcomes

Primary

Measure	Time frame
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 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. ;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) ;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.	—

Measure

Time frame

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 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. ;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) ;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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Contacts

Public ContactProject leader Prader-Willi Study

Dutch Growth Research Foundation

info@kindengroei.nl0031102251533

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026