Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome
Phase 2
Completed
- Conditions
- Prader-Willi Syndrome
- Interventions
- Registration Number
- NCT02804373
- Lead Sponsor
- University Hospital, Toulouse
- Brief Summary
The investigator thinks that the oxytocin (OT) can improve durably and significantly the behavior disorders and thus the socialization but also the satisfaction and could thus be an interesting therapeutic alternative for the patients presenting a Prader-Willi Syndrome (SPW). Although today several studies demonstrated the effects of the OT in various domains of the behavior, the investigator do not know either its specificity of action about the cerebral level, or its duration of action, or the optimal modalities of administration and in particular at patients SPW.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Prader-Willi syndrome genetically confirmed
- Absence of extension of the QT interval in the electrocardiogram
- Absence of hypokalemia
Exclusion Criteria
- Psychiatric troubles
- Anomalies of the heart rhythm in significant ECG
- Hepatic insufficiency
- Renal insufficiency
- Patients presenting a pregnancy or breast-feeding
- High sensibility to OT
- High sensibility to the excipients of the product
- Patients having family history of genetic pathology causing an extension of the interval QT
- Patients having risk factors of advanced twist
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo daily Placebo continuous daily administration of placebo during 28 days : placebo continuous 24 IU of oxytocin every 3 days Placebo 24 IU of daily oxytocin every 3 days and placebo the following 2 days after each oxytocin administration during 28 days 24 IU of oxytocin daily Oxytocin (OXT) continuous 24 IU of daily oxytocin administration during 28 days : oxytocin continuous 24 IU of oxytocin every 3 days Oxytocin 24 IU of daily oxytocin every 3 days and placebo the following 2 days after each oxytocin administration during 28 days
- Primary Outcome Measures
Name Time Method Change in Behaviour as assessed by score variations in specific questionaries Every day before and after administration of treatment during 28 days Change in eating Behaviour as assessed by score variations in specific questionaries Every day before and after administration of treatment during 28 days
- Secondary Outcome Measures
Name Time Method Change in eating behaviour as assessed by score variations in hunger visual analogic scale Every day before and after administration of treatment during 28 days Cerebral Metabolism variations as assessed by Positron Emission Tomography (PET-scan) Day 1, day 2 and day 30 Brain imaging
Evaluation of social skills assessed by specific questionnaires Day 1, day 2 and day 30 Social processing assessed by oculomotor exploration Day 1, day 2 and day 30 Multisensory processing assessed by Neurovisual task Day 1, day 2 and day 30 Hormon blood concentration levels as assessed by bioassays Day 2 and day 30 Cerebral Metabolism variations as assessed by functional Magnetic Resonance Imaging (f-RMI) Day 1, day 2 and day 29 Brain imaging
Evaluation of executive function assessed by specific questionnaires Day 1, day 2 and day 30 Evaluation of theory of mind assessed by specific questionnaires Day 1, day 2 and day 30
Trial Locations
- Locations (1)
Centre de référence Prader-Willi - Hôpital Purpan
🇫🇷Toulouse, France