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Prospective observational study developed to generate more evidence of the safety profile, clinical characteristics and outcomes of patients with PWS treated with VYKAT XR.
Patients with PWS at participating sites who are initiating treatment or have initiated treatment with VYKAT XR, including patients who were previously treated with DCCR in a prior clinical study, will be invited to participate. Data from treatment prior to enrollment either from clinical practice or from previous DCCR clinical trials may be collected retrospectively.
Clinical care will not be mandated by the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with PWS who are currently receiving or initiating treatment with VYKAT XR. | All patients with PWS at participating sites who are initiating treatment or have initiated treatment with VYKAT XR at the time of enrollment into this observational study, including patients who were previously treated with DCCR in a prior clinical study, will be invited to participate. Although the overall observational study is prospective, data from treatment prior to enrollment into the observational study, either from clinical practice or from DCCR clinical trials, may be collected retrospectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VYKAT XR | Drug | All prospective treatment in this protocol will be commercial VYKAT XR prescribed to patients by their physicians in addition to their standard of care; patients will not receive experimental intervention or treatment from the Sponsor as part of their participation in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess safety profile of patients with PWS treated with VYKAT XR. | The safety profile will be based on adverse events, including nonserious adverse events, serious adverse events, and adverse events leading to discontinuation of VYKAT XR. | Adverse events for each patient will be collected from the time of first dose on VYKAT XR until the last contact with the patient. |
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Inclusion Criteria:
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This study will enroll patients with PWS who are currently receiving or initiating treatment with VYKAT XR.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| Emory Children's Center |
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|
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | United States |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48912 | United States |
| Children's Minnesota | Saint Paul | Minnesota | 55102 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64111 | United States |
| Saint Josephs Health | Paterson | New Jersey | 07503 | United States |
| Long Island Jewish Valley Stream | Valley Stream | New York | 11580 | United States |
| UNC Hospitals | Chapel Hill | North Carolina | 27514 | United States |
| Legacy Emanuel Medical Center | Portland | Oregon | 97227 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Children's Medical Center Dallas | Dallas | Texas | 75231 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| ID | Term |
|---|---|
| D011218 | Prader-Willi Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D000096803 | Imprinting Disorders |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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