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Clinical Trials/NL-OMON43050
NL-OMON43050
Withdrawn
Not Applicable

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

Stichting Kind en Groei0 sites44 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Stichting Kind en Groei
Enrollment
44
Status
Withdrawn
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Stichting Kind en Groei

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

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

Similar Trials

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Intranasal administration of oxytocin in children with Prader-Willi Syndrome. A randomized, double-blind, placebo-controlled cross-over trial. Effects on satiety and food intake, and social behaviour.;Amendment: Six months open-label extension to the original studyPrader-Willi syndrome10083624
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Unknown
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