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

July 6, 2015 updated by: Ferring Pharmaceuticals
The purpose of this study is to evaluate the safety and effectiveness of intranasal FE 992097 in children and adults with Prader-Willi Syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States
        • Florida University
    • New York
      • Mineola, New York, United States
        • Winthrop University
    • Tennessee
      • Nashville, Tennessee, United States
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: FE 992097
Drug: FE 992097

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

October 18, 2013

First Posted (Estimate)

October 23, 2013

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 6, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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