Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome

Hyperphagia in Prader-Willi Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968187
• Other study ID #: 000114
• Status: Completed
• Phase: Phase 2
• First received: October 9, 2013
• Last updated: July 6, 2015
• Start date: January 2014
• Est. completion date: July 2014

Study information

• Verified date: July 2015
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• Male or female 10-18 years of age (both inclusive)

• Genetically confirmed diagnosis of Prader-Willi Syndrome

• Determined to be in nutritional phase 3 by clinical assessment based on Miller et al, 2011

Exclusion Criteria:

• Known genetic, hormonal, or chromosomal cause of cognitive impairment other than Prader-Willi Syndrome

• Presence of currently active psychotic symptoms

• Presence of any cardiovascular disorders, epilepsy, frequent migraines or severe asthma

• Previous diagnosis of autism spectrum disorder by a qualified healthcare provider

• Prior or concomitant use of a selective serotonin reuptake inhibitor (SSRI) or selective norepinephrine reuptake inhibitor (SNRI), antipsychotic medication, wakefulness-promoting drug, or thyroid hormone unless dosage has been stable =6 months at time of screening

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperphagia
• Hyperphagia in Prader-Willi Syndrome
• Prader-Willi Syndrome

Intervention

Drug:
• FE 992097

• Placebo

Locations

Country	Name	City	State
United States	Florida University	Gainesville	Florida
United States	Winthrop University	Mineola	New York
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total hyperphagia score as measured by a Hyperphagia for Prader-Willi Syndrome Questionnaire		from day 1 to day 15	No
Secondary	Clinical Global Impression - Improvement score		at day 15	No
Secondary	Change in Hyperphagia for Prader-Willi Syndrome Questionnaire domain scores		from day 1 to day 15	No
Secondary	Change in Children's Yale-Brown Obsessive Compulsive Scale score		from screening to day 15	No
Secondary	Change in the food domain of the Reiss Profile		from screening to day 15	No