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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01968187
Recruitment Status : Completed
First Posted : October 23, 2013
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hyperphagia in Prader-Willi Syndrome Drug: FE 992097 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : January 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: FE 992097 Drug: FE 992097
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change in total hyperphagia score as measured by a Hyperphagia for Prader-Willi Syndrome Questionnaire [ Time Frame: from day 1 to day 15 ]

Secondary Outcome Measures :
  1. Clinical Global Impression - Improvement score [ Time Frame: at day 15 ]
  2. Change in Hyperphagia for Prader-Willi Syndrome Questionnaire domain scores [ Time Frame: from day 1 to day 15 ]
  3. Change in Children's Yale-Brown Obsessive Compulsive Scale score [ Time Frame: from screening to day 15 ]
  4. Change in the food domain of the Reiss Profile [ Time Frame: from screening to day 15 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968187


Locations
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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
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Study Director: Clinical Development Support Ferring Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01968187    
Other Study ID Numbers: 000114
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Prader-Willi Syndrome
Syndrome
Hyperphagia
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overweight
Overnutrition
Nutrition Disorders
Signs and Symptoms, Digestive