Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome (NCT02804373) | Clinical Trial Compass
CompletedPhase 2/3
Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome
France50 participantsStarted 2014-06
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Behaviour as assessed by score variations in specific questionaries
Timeframe: Every day before and after administration of treatment during 28 days
2
Change in eating Behaviour as assessed by score variations in specific questionaries
Timeframe: Every day before and after administration of treatment during 28 days