Clinical trial NCT02804373: Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome
Official title: Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prader-Willi Syndrome
Keywords: oxytocin
adults
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Behaviour as assessed by score variations in specific questionaries
timeFrame: Every day before and after administration of treatment during 28 days
measure: Change in eating Behaviour as assessed by score variations in specific questionaries
timeFrame: Every day before and after administration of treatment during 28 days
Secondary outcomes:
measure: Change in eating behaviour as assessed by score variations in hunger visual analogic scale
timeFrame: Every day before and after administration of treatment during 28 days
measure: Cerebral Metabolism variations as assessed by Positron Emission Tomography (PET-scan)
timeFrame: Day 1, day 2 and day 30
measure: Cerebral Metabolism variations as assessed by functional Magnetic Resonance Imaging (f-RMI)
timeFrame: Day 1, day 2 and day 29
measure: Evaluation of social skills assessed by specific questionnaires
timeFrame: Day 1, day 2 and day 30
measure: Evaluation of executive function assessed by specific questionnaires
timeFrame: Day 1, day 2 and day 30
measure: Evaluation of theory of mind assessed by specific questionnaires
timeFrame: Day 1, day 2 and day 30
measure: Social processing assessed by oculomotor exploration
timeFrame: Day 1, day 2 and day 30
measure: Multisensory processing assessed by Neurovisual task
timeFrame: Day 1, day 2 and day 30
measure: Hormon blood concentration levels as assessed by bioassays
timeFrame: Day 2 and day 30
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Centre de référence Prader-Willi - Hôpital Purpan
Study officials:
affiliation: University Hospital, Toulouse
name: Maithé TAUBER, MD
role: PRINCIPAL_INVESTIGATOR
References: