Intranasal administration of oxytocin in children with Prader-Willi syndrome

Randomized, double-blind, placebo-controlled oxytocin and dose-response trial in children with Prader-Willi syndrome. Effects on social behaviour.

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003423-30-NL

Enrollment

Registered

2017-10-04

Start date

2017-12-12

Completion date

Unknown

Last updated

2018-01-08

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: 20.0 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 - Children aged 3 to 10.99 years - Informed consent - Currently on growth hormone treatment for at least 1 year - Behavioural characteristics such as reduced social reciprocity and interaction, repetitive behaviour or temper tantrums, and/or be in nutritional phase 2b or 3 according to Miller (increased interest in food, hyperphagia) Are the trial subjects under 18? yes Number of subjects for this age range: 33 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

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Severe psychiatric problems - Non-cooperative behaviour - Allergic reactions or hypersensitivity for oxytocin - Serious illness - Cardiac abnormalities - Extremely low dietary intake or less than required itnake acoording to WHO - Medication to reduce weight (fat)

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effects of oxytocin on social behaviour in children with Prader-Willi syndrome aged 3-11 years;Secondary Objective: - To evaluate the effects on appetite, satiety, food intake and food seeking behaviour in children with PWS aged 3-11 years - To evaluate oxytocin levels in blood and saliva samples before and during intransal oxytocin treatment - To evaluate if there is a difference in effect between once or twice daily adminsitration - To evaluate effects in relation to: BMI and body composition by DXA, IGF-1 and IGF-BP3-levels, genetic subtype;Primary end point(s): Changes in social behaviour assessed by: - Repetitive Behavior Scale-Revised - Social Responsiveness-Scale;Timepoint(s) of evaluation of this end point: Day 1 and 3, 4, 7 and 13 months	—

Measure

Time frame

Main Objective: To evaluate the effects of oxytocin on social behaviour in children with Prader-Willi syndrome aged 3-11 years;Secondary Objective: - To evaluate the effects on appetite, satiety, food intake and food seeking behaviour in children with PWS aged 3-11 years - To evaluate oxytocin levels in blood and saliva samples before and during intransal oxytocin treatment - To evaluate if there is a difference in effect between once or twice daily adminsitration - To evaluate effects in relation to: BMI and body composition by DXA, IGF-1 and IGF-BP3-levels, genetic subtype;Primary end point(s): Changes in social behaviour assessed by: - Repetitive Behavior Scale-Revised - Social Responsiveness-Scale;Timepoint(s) of evaluation of this end point: Day 1 and 3, 4, 7 and 13 months

—

Secondary

Measure	Time frame
Secondary end point(s): Change in: - Clinical Global Impression scale - Quality of life (DUX25 and DUXPWS) - Social Behaviour (VISK, Oxytocin questionnaire revised) - Hyperphagia (Hyperphagia questionnaire Dykens) - Reading the Mind in the Eyes test, child version - Body Composition (Anthropometric measurements, BMI and DXA-scan) - Social and food related behaviour (diary) - Food intake (diary) - Laboratory parameters (oxytocin in saliva and blood) - Safety parameters (laboratory parameters and medical assessments);Timepoint(s) of evaluation of this end point: Day 1 and 3, 4, 7 and 13 months	—

Measure

Time frame

Secondary end point(s): Change in: - Clinical Global Impression scale - Quality of life (DUX25 and DUXPWS) - Social Behaviour (VISK, Oxytocin questionnaire revised) - Hyperphagia (Hyperphagia questionnaire Dykens) - Reading the Mind in the Eyes test, child version - Body Composition (Anthropometric measurements, BMI and DXA-scan) - Social and food related behaviour (diary) - Food intake (diary) - Laboratory parameters (oxytocin in saliva and blood) - Safety parameters (laboratory parameters and medical assessments);Timepoint(s) of evaluation of this end point: Day 1 and 3, 4, 7 and 13 months

—

Countries

Netherlands

Contacts

Public ContactProject leader Prader-Willi study

Dutch Growth Research Foundation

praderwilli@kindengroei.nl0031102251533

Outcome results

None listed

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