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)

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

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