Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi S… (NCT01968187) | Clinical Trial Compass
CompletedPhase 2
Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome
United States38 participantsStarted 2014-01-20
Plain-language 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.
Who can participate
Age range10 Years – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change From Baseline in Hyperphagia in Prader-Willi Syndrome (PWS) Questionnaires- Responsiveness (HPWSQ-R) Total Score at End-of-treatment (Day 15)