Oxytocin intranasal administrations in children with Prader-Willi syndrome aged from 3 to 12 years.

• Register: EUCTR
• Last refreshed on: 16 November 2020
• Main ID: EUCTR2016-003273-18-FR
• Date of registration: 22/08/2016
• Prospective Registration: Yes
• Primary sponsor: University Hospital of Toulouse
• Public title: Oxytocin intranasal administrations in children with Prader-Willi syndrome aged from 3 to 12 years.
• Scientific title: 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
• Date of first enrolment: 14/11/2016
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003273-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: yes Other trial design description: two blind arms during 12 weeks and then one arm during 12 weeks If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

France

Contacts

• Name: ALGANS
• Affiliation: University Hospital of Toulouse

• Name: ALGANS
• Affiliation: University Hospital of Toulouse

Key inclusion & exclusion criteria

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Prader-Willi Syndrom

Intervention(s)

Trade Name: Syntocinon
Pharmaceutical Form: Nasal spray
Pharmaceutical form of the placebo: Nasal spray
Route of administration of the placebo: Nasal use

Primary Outcome(s)

Primary end point(s): evolution of behavioural troubles evaluated by the global score of CBCL questionnaire after 12 weeks of OXT or placebo treatment

Secondary Objective: Study the effect of the intranasal administration of OXT during 12 weeks by comparison with a placebo on :
The hyperphagia
The social skills
The auto and hetero aggressives behaviors
The psychopathology
the global clinical state
The evolution of the circulating rates of acyl and non acyl ghreline

Main Objective: Study the effect of the administration intranasale of oxytocin (OXT) during 12 weeks on the behavior disorders by comparison with a placebo

Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 12 weeks and at inclusion

Secondary end point(s): Evaluation of hyperphagia evaluated by Dykens questionnaire
- social skills by PSA questionnaire for children aged from 3 to 6 years and by SRS questionnaire for children aged from 7 to 12 years.
- auto- and hetero-aggressive behavior by ECAA questionnaire
- psychopatholy of patient evaluated by the 3 following subscores of CBCL questionnaire
- global clinical status of patient evaluated by a specific PWS grid
- acyl and desacyl grelin plasma levels
For patients aged from 7 to 12 years at inclusion:
- attentional abilities by ANT (Attention Network Test)
- metabolic brain resting state BY mri

Secondary ID(s)

RC31-15-7837

Source(s) of Monetary Support

University Hospital of Toulouse

Ethics review

Status: Approved
Approval date: 05/10/2016
Contact: