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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals

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