Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome
Primary Purpose
Hyperphagia in Prader-Willi Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FE 992097
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperphagia in Prader-Willi Syndrome
Eligibility 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
Sites / Locations
- Florida University
- Winthrop University
- Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
FE 992097
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in total hyperphagia score as measured by a Hyperphagia for Prader-Willi Syndrome Questionnaire
Secondary Outcome Measures
Clinical Global Impression - Improvement score
Change in Hyperphagia for Prader-Willi Syndrome Questionnaire domain scores
Change in Children's Yale-Brown Obsessive Compulsive Scale score
Change in the food domain of the Reiss Profile
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01968187
Brief Title
Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphagia in Prader-Willi Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FE 992097
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
FE 992097
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Clinical Global Impression - Improvement score
Time Frame
at day 15
Title
Change in Hyperphagia for Prader-Willi Syndrome Questionnaire domain scores
Time Frame
from day 1 to day 15
Title
Change in Children's Yale-Brown Obsessive Compulsive Scale score
Time Frame
from screening to day 15
Title
Change in the food domain of the Reiss Profile
Time Frame
from screening to day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Florida University
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Winthrop University
City
Mineola
State/Province
New York
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29925684
Citation
Dykens EM, Miller J, Angulo M, Roof E, Reidy M, Hatoum HT, Willey R, Bolton G, Korner P. Intranasal carbetocin reduces hyperphagia in individuals with Prader-Willi syndrome. JCI Insight. 2018 Jun 21;3(12):e98333. doi: 10.1172/jci.insight.98333. eCollection 2018 Jun 21.
Results Reference
derived
Learn more about this trial
Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome
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