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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01968187
First received: October 9, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968187

Locations
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
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01968187     History of Changes
Other Study ID Numbers: 000114
Study First Received: October 9, 2013
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prader-Willi Syndrome
Syndrome
Hyperphagia
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014