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Clinical Trials/EUCTR2017-003423-30-NL
EUCTR2017-003423-30-NL
Active, not recruiting
Phase 1

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

Dutch Growth Research Foundation0 sites33 target enrollmentOctober 4, 2017
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ConditionsPrader-Willi syndromeMedDRA version: 20.0Level: 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
Enrollment
33
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 4, 2017
End Date
TBD
Last Updated
8 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
  • •\- 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

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)

Outcomes

Primary Outcomes

Not specified

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