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

Prader-Willi Syndrome Clinical Trial

— PRADOTIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804373
• Other study ID #: 13 6872 03
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 2014
• Est. completion date: June 18, 2019

Study information

• Verified date: July 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 18, 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Prader-Willi Syndrome
• Syndrome

Intervention

Drug:
• Oxytocin (OXT) continuous
Administration of 24 IU of oxytocin daily during 28 days
• Placebo
Placebo daily during 28 days
• Placebo continuous
Placebo administration the following 2 days after each OXT administration, during 28 days.
• Oxytocin
Administration of 24 IU of oxytocin every 3 days during 28 days.

Locations

Country	Name	City	State
France	Centre de référence Prader-Willi - Hôpital Purpan	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Behaviour as assessed by score variations in specific questionaries		Every day before and after administration of treatment during 28 days
Primary	Change in eating Behaviour as assessed by score variations in specific questionaries		Every day before and after administration of treatment during 28 days
Secondary	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
Secondary	Cerebral Metabolism variations as assessed by Positron Emission Tomography (PET-scan)	Brain imaging	Day 1, day 2 and day 30
Secondary	Cerebral Metabolism variations as assessed by functional Magnetic Resonance Imaging (f-RMI)	Brain imaging	Day 1, day 2 and day 29
Secondary	Evaluation of social skills assessed by specific questionnaires		Day 1, day 2 and day 30
Secondary	Evaluation of executive function assessed by specific questionnaires		Day 1, day 2 and day 30
Secondary	Evaluation of theory of mind assessed by specific questionnaires		Day 1, day 2 and day 30
Secondary	Social processing assessed by oculomotor exploration		Day 1, day 2 and day 30
Secondary	Multisensory processing assessed by Neurovisual task		Day 1, day 2 and day 30
Secondary	Hormon blood concentration levels as assessed by bioassays		Day 2 and day 30