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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

Tracking Information
First Submitted Date  ICMJE October 9, 2013
First Posted Date  ICMJE October 23, 2013
Last Update Posted Date July 28, 2015
Study Start Date  ICMJE January 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2013)
Change in total hyperphagia score as measured by a Hyperphagia for Prader-Willi Syndrome Questionnaire [ Time Frame: from day 1 to day 15 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
  • Clinical Global Impression - Improvement score [ Time Frame: at day 15 ]
  • Change in Hyperphagia for Prader-Willi Syndrome Questionnaire domain scores [ Time Frame: from day 1 to day 15 ]
  • Change in Children's Yale-Brown Obsessive Compulsive Scale score [ Time Frame: from screening to day 15 ]
  • Change in the food domain of the Reiss Profile [ Time Frame: from screening to day 15 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2013)
  • Clinical Global Impression - Improvement score [ Time Frame: at day 15 ]
  • Change in Hyperphagia for Prader-Willi Syndrome Questionnaire domain scores [ Time Frame: from day 1 to day 15 ]
  • Change in Children's Yale-Brown Obsessive Compulsive Scale score [ Time Frame: from day 1 to day 15 ]
  • Change in the food domain of the Reiss Profile [ Time Frame: from day 1 to day 15 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hyperphagia in Prader-Willi Syndrome
Intervention  ICMJE
  • Drug: FE 992097
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: FE 992097
    Intervention: Drug: FE 992097
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * 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). pii: 98333. doi: 10.1172/jci.insight.98333. eCollection 2018 Jun 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2013)
38
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01968187
Other Study ID Numbers  ICMJE 000114
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Development Support Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP