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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperphagia in Prader-Willi Syndrome

In brief

The purpose of this study is to evaluate the safety and effectiveness of intranasal FE 992097 in children and adults with Prader-Willi Syndrome.

Key facts

Study ID

NCT01968187

Run by

Ferring Pharmaceuticals

People needed

38

Starts

2014-01-20

Expected to finish

2014-07-16

Last updated by the study team

2025-03-27

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.