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Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Effectiveness of Intranasal Carbetocin in Subjects With Prader-Willi Syndrome (PWS)

NCT01968187•Ferring Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

10 - 18 years

Sex

ALL

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 Prader-Willi Syndrome 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

Locations (3)

Florida University

Gainesville, Florida, United States

Winthrop University

Mineola, New York, United States

Vanderbilt University

Nashville, Tennessee, United States

Key Dates

Start Date

January 20, 2014

Primary Completion Date

July 16, 2014

Completion Date

July 16, 2014

Last Updated

March 27, 2025

Enrollment

ACTUAL participants

Conditions

Hyperphagia in Prader-Willi Syndrome

Interventions

FE 992097

DRUG

Placebo

DRUG

OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

NCT06420297

Hyperphagia in Prader-Willi Syndrome

View study

SUSPENDEDPHASE3

The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial

NCT07197034

HyperphagiaPrader-Willi Syndrome+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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