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

Ferring

Status and phase: Completed; Phase 2

Conditions: Hyperphagia in Prader-Willi Syndrome

Treatments: Drug: Placebo; Drug: FE 992097

Study type: Interventional

Funder types: Industry

Identifiers

NCT01968187

000114

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups, including a placebo group

Carbetocin (FE 992097)

Experimental group

Treatment:

Drug: FE 992097

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo