Clinical Trial: Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title:
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of intranasal FE 992097 in children and adults with Prader-Willi Syndrome.
Detailed Summary:
Sponsor: Ferring Pharmaceuticals
Current Primary Outcome: Change in total hyperphagia score as measured by a Hyperphagia for Prader-Willi Syndrome Questionnaire [ Time Frame: from day 1 to day 15 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Clinical Global Impression - Improvement score [ Time Frame: at day 15 ]
- Change in Hyperphagia for Prader-Willi Syndrome Questionnaire domain scores [ Time Frame: from day 1 to day 15 ]
- Change in Children's Yale-Brown Obsessive Compulsive Scale score [ Time Frame: from screening to day 15 ]
- Change in the food domain of the Reiss Profile [ Time Frame: from screening to day 15 ]
Original Secondary Outcome:
- Clinical Global Impression - Improvement score [ Time Frame: at day 15 ]
- Change in Hyperphagia for Prader-Willi Syndrome Questionnaire domain scores [ Time Frame: from day 1 to day 15 ]
- Change in Children's Yale-Brown Obsessive Compulsive Scale score [ Time Frame: from day 1 to day 15 ]
- Change in the food domain of the Reiss Profile [ Time Frame: from day 1 to day 15 ]
Information By: Ferring Pharmaceuticals
Dates:
Date Received: October 9, 2013
Date Started: January 2014
Date Completion:
Last Updated: July 6, 2015
Last Verified: July 2015
