NCT02804373

Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
DRUG	Oxytocin (OXT) continuous	Administration of 24 IU of oxytocin daily during 28 days
DRUG	Placebo	Placebo daily during 28 days
DRUG	Placebo continuous	Placebo administration the following 2 days after each OXT administration, during 28 days.
DRUG	Oxytocin	Administration of 24 IU of oxytocin every 3 days during 28 days.

Timeline

• Start date: 2014-06-01
• Primary completion: 2019-01-01
• Completion: 2019-06-18
• First posted: 2016-06-17
• Last updated: 2025-12-05

Locations

1 site across 1 country: France