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

This study has been completed.
Information provided by (Responsible Party):
Ferring Pharmaceuticals Identifier:
First received: October 9, 2013
Last updated: July 6, 2015
Last verified: July 2015
The purpose of this study is to evaluate the safety and effectiveness of intranasal FE 992097 in children and adults with Prader-Willi Syndrome.

Condition Intervention Phase
Hyperphagia in Prader-Willi Syndrome
Drug: FE 992097
Drug: Placebo
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Change in total hyperphagia score as measured by a Hyperphagia for Prader-Willi Syndrome Questionnaire [ Time Frame: from day 1 to day 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression - Improvement score [ Time Frame: at day 15 ] [ Designated as safety issue: No ]
  • Change in Hyperphagia for Prader-Willi Syndrome Questionnaire domain scores [ Time Frame: from day 1 to day 15 ] [ Designated as safety issue: No ]
  • Change in Children's Yale-Brown Obsessive Compulsive Scale score [ Time Frame: from screening to day 15 ] [ Designated as safety issue: No ]
  • Change in the food domain of the Reiss Profile [ Time Frame: from screening to day 15 ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: January 2014
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FE 992097 Drug: FE 992097
Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01968187

United States, Florida
Florida University
Gainesville, Florida, United States
United States, New York
Winthrop University
Mineola, New York, United States
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States
Sponsors and Collaborators
Ferring Pharmaceuticals
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Responsible Party: Ferring Pharmaceuticals Identifier: NCT01968187     History of Changes
Other Study ID Numbers: 000114 
Study First Received: October 9, 2013
Last Updated: July 6, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prader-Willi Syndrome
Abnormalities, Multiple
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Intellectual Disability
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Nutrition Disorders
Signs and Symptoms
Signs and Symptoms, Digestive processed this record on May 30, 2016