EUCTR2016-003273-18-FRActive, not recruitingPhase 1
Effects of intranasal administrations of oxytocin on beahvioural troubles, hyperphagia and social skills in children with Prader-Willi syndrome aged from 3 to 12 years. - OXYJEUNE
niversity Hospital of Toulouse0 sites40 target enrollmentStarted: August 22, 2016Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •patient with a complete genetic diagnosis of PWS
- •patient aged from 3 to 12 years
- •patient treated by growth hormone for at least 1 year
- •patient naïve for OXT for at least 5 years
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •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
- •patient who do not accept intranasal administrations (major behavioural trouble)
- •patient with hepatic insufficiency : serum transaminases higher than 3 times normal values for age
- •patient with renal insufficiency : serum creatinine higher than 3 times normal values for age
- •patient with an antecedent of abnormal electrocardiogram
- •patient with arterial hypertension or hypotension
- •patient with type 1 or 2 diabetes
Investigators
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