Oxytocin treatment for Prader Willi Syndrome

Phase 2

Completed

• Conditions: Prader Willi Syndrome; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders

• Registration Number: ACTRN12609000982213
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Genetically proven diagnosis of Prader Willi Syndrome
Mental age above 10 years

Exclusion Criteria

- Persons below 12 years
-Persons with a mental age below 10 years
- Persons without genetically proven diagnosis of Prader Willi Syndrome
- Persons hypersensitive to the preservatives in the nasal spray, viz E216, E218 and chlorobutanol will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eating behaviours (hyperphagia and pica) as measured by the Developmental Behaviour Checklist - Monitoring Chart (DBC-M)[Daily during each of the 8 week trial periods of the oxytocin or nasal sprays.];Rages/tantrums as measured by the Developmental Behaviour Checklist - Monitoring Chart (DBC-M)[Daily during each of the 8 week trial periods of the oxytocin or nasal sprays.];Weight[Baseline at week 1<br>Weekly at home<br>Baseline at week 11<br>Weekly at home<br>End of week 18]