Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 10 - 18 |
| Updated: | 4/21/2016 |
| Start Date: | January 2014 |
| End Date: | July 2014 |
The purpose of this study is to evaluate the safety and effectiveness of intranasal FE
992097 in children and adults with Prader-Willi Syndrome.
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 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
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