Intranasal administration of oxytocin in children with Prader-Willi Syndrome

Intranasal administration of oxytocin in children with Prader-Willi Syndrome. A randomized, open-label, cross-over trial of different treatment regimens of oxytocin administration. Effects on eating behaviour and social behaviour. - Intranasal administration of oxytocin in children with PWS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003820-22-NL

Enrollment

Unknown

Registered

2016-10-12

Start date

2016-12-22

Completion date

Unknown

Last updated

2017-01-23

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: 19.0 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

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 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

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: - To evaluate the effects of long-term intranasal oxytocin on social behaviour in children with PWS - To evaluate the effects of long-term intranasal oxytocin administration on appetite, satiety, food intake and food seeking behaviour in children with PWS - To investigate if there is a difference in the efficacy of oxytocin if adminstered in different doses and frequencies;Secondary Objective: To evaluate oxytocin levels in blood and saliva samples before, during and after intranasal oxytocin treatment in different doses and frequencies in children with PWS - To evaluate the effects of long-term intranasal oxytocin administration in different doses and frequencies in relation to: BMI, IGF-1 and IGF-BP3 levels, fMRI (BOLD response) ;Primary end point(s): Changes in social and food related behaviour assessed by: - Oxytocin Study Questionnaire - VISK;Timepoint(s) of evaluation of this end point: Studygroup 1: Day 1: baseline assessments in the hospital, first administration of oxytocin followed by observation period and instruction of administration Day 2-month 6: administration of oxytocin one/twice a day every day at home - 6 months: hospital visit and assessments as mentioned on day 1 - Mont 6-month 7: wash-out period - 7 months: parents fill out a questionnaire at home. Start other dosing regimen. Month 7-month 13: administration of oxytocin once/twice daily every day at home 13 months: hospital visit and assessment as mentioned on day 1 For studygroup 2 assessments will be done on day 1 (hospital), at 3 months (hospital), at 4 months (questionnaire at home), 7 months (hospital)	—

Measure

Time frame

Main Objective: - To evaluate the effects of long-term intranasal oxytocin on social behaviour in children with PWS - To evaluate the effects of long-term intranasal oxytocin administration on appetite, satiety, food intake and food seeking behaviour in children with PWS - To investigate if there is a difference in the efficacy of oxytocin if adminstered in different doses and frequencies;Secondary Objective: To evaluate oxytocin levels in blood and saliva samples before, during and after intranasal oxytocin treatment in different doses and frequencies in children with PWS - To evaluate the effects of long-term intranasal oxytocin administration in different doses and frequencies in relation to: BMI, IGF-1 and IGF-BP3 levels, fMRI (BOLD response) ;Primary end point(s): Changes in social and food related behaviour assessed by: - Oxytocin Study Questionnaire - VISK;Timepoint(s) of evaluation of this end point: Studygroup 1: Day 1: baseline assessments in the hospital, first administration of oxytocin followed by observation period and instruction of administration Day 2-month 6: administration of oxytocin one/twice a day every day at home - 6 months: hospital visit and assessments as mentioned on day 1 - Mont 6-month 7: wash-out period - 7 months: parents fill out a questionnaire at home. Start other dosing regimen. Month 7-month 13: administration of oxytocin once/twice daily every day at home 13 months: hospital visit and assessment as mentioned on day 1 For studygroup 2 assessments will be done on day 1 (hospital), at 3 months (hospital), at 4 months (questionnaire at home), 7 months (hospital)

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Secondary

Measure	Time frame
Secondary end point(s): Change in: - Body composition - Quality of life - Hyperphagia questionnaire - Theory of Mind test - Diary concerning social and food related behaviour - fMRI (>6 years old) - Laboratory parameters - Safety parameters;Timepoint(s) of evaluation of this end point: Studygroup 1: Day 1: baseline assessments in the hospital, first administration of oxytocin followed by observation period and instruction of administration Day 2-month 6: administration of oxytocin one/twice a day every day at home - 6 months: hospital visit and assessments as mentioned on day 1 - Mont 6-month 7: wash-out period - 7 months: parents fill out a questionnaire at home. Start other dosing regimen. Month 7-month 13: administration of oxytocin once/twice daily every day at home 13 months: hospital visit and assessment as mentioned on day 1 For studygroup 2 assessments will be done on day 1 (hospital), at 3 months (hospital), at 4 months (questionnaire at home), 7 months (hospital)	—

Measure

Time frame

Secondary end point(s): Change in: - Body composition - Quality of life - Hyperphagia questionnaire - Theory of Mind test - Diary concerning social and food related behaviour - fMRI (>6 years old) - Laboratory parameters - Safety parameters;Timepoint(s) of evaluation of this end point: Studygroup 1: Day 1: baseline assessments in the hospital, first administration of oxytocin followed by observation period and instruction of administration Day 2-month 6: administration of oxytocin one/twice a day every day at home - 6 months: hospital visit and assessments as mentioned on day 1 - Mont 6-month 7: wash-out period - 7 months: parents fill out a questionnaire at home. Start other dosing regimen. Month 7-month 13: administration of oxytocin once/twice daily every day at home 13 months: hospital visit and assessment as mentioned on day 1 For studygroup 2 assessments will be done on day 1 (hospital), at 3 months (hospital), at 4 months (questionnaire at home), 7 months (hospital)

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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