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Clinical Trials/EUCTR2016-003820-22-NL
EUCTR2016-003820-22-NL
Active, not recruiting
Phase 1

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

Dutch Growth Research Foundation0 sitesOctober 12, 2016
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ConditionsPrader-Willi syndromeMedDRA version: 19.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
DrugsSyntocinon nasal spray

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Prader-Willi syndrome
Sponsor
Dutch Growth Research Foundation
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 12, 2016
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Dutch Growth Research Foundation

Eligibility 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

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)

Outcomes

Primary Outcomes

Not specified

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