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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

About this trial

This is an interventional treatment trial for Hyperphagia in Prader-Willi Syndrome

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT01968187

First Posted

October 9, 2013

Last Updated

July 6, 2015

Sponsor

Ferring Pharmaceuticals

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

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

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

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

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