Prader Willi Syndrom MedDRA version: 20.0 Level: PT Classification code 10036476 Term: Prader-Willi syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: Syntocinon
Pharmaceutical Form: Nasal spray
Sponsors
Centre Hospitalier de Toulouse
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants with PWS genetically confirmed Aged less than 5 months Are the trial subjects under 18? yes Number of subjects for this age range: 18 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
Exclusion criteria: Infants presenting hepatic insufficiency Infants presenting renal insufficiency Infants with abnormal ECG
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study tolerance oxytocin repeated nasal administrations during 7 days (according to 3 plans of administration) to babies with Prader Willi Syndrom younger than 5 months. ;Secondary Objective: • Preliminary study of efficacy on: • suckling and swallowing and quantity of milk intake/day • infant-mother interactions before during and after feeding • weight gain and growth • Pathophysiological study of • cerebral metabolism (fMRI bold) • plasma levels of ghrelin and other peptides involved in feeding behaviour or energy metabolism • Pharmacokinetic study “à minima”: measurement of circulating oxytocin levels before administration and every 48hrs. ;Primary end point(s): Occurrence of adverse event, description and quantification of their severity, imputability to repeated intranasal administration of OT ;Timepoint(s) of evaluation of this end point: during 7 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Preliminary study of efficacy on: Suckling and swallowing and quantity of milk intake/day Infant-mother interactions before during and after feeding weight gain and growth Pathophysiological study of cerebral metabolism (fMRI bold) plasma levels of ghrelin and other peptides involved in feeding behaviour or energy metabolism Pharmacokinetic study “à minima”: measurement of circulating oxytocin levels before administration and every 48hrs.;Timepoint(s) of evaluation of this end point: Before and during 7 days after OT admininistration. | — |
Countries
France
Contacts
Public ContactALGANS
Centre hospitalier de Toulouse
Outcome results
None listed