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The purpose of this is study is to evaluate the long-term safety of DCCR (diazoxide choline) extended-release tablets) in patients with Prader-Willi syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCCR | Experimental | 75 - 525 mg DCCR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCCR | Drug | Once daily oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of DCCR (adverse events. Safety analyses will be conducted in all subjects who receive at least one dose of DCCR in the C614 study. ( Adverse events) | Assess the safety of DCCR by evaluating the incidence and severity of adverse events. Safety analyses will be conducted in all subjects who receive at least one dose of DCCR in the C614 study. Adverse events will be described by type and level of severity. | Baseline to End of Study or until resolution of certain adverse events |
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Inclusion Criteria:
Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (subjects, as appropriate)
Participant must:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Irvine | Orange | California | 92868 | United States | ||
| Stanford University |
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| Palo Alto |
| California |
| 94304 |
| United States |
| Rady Children's Hospital of San Diego | San Diego | California | 92123 | United States |
| U of Florida Gainesville | Gainesville | Florida | 32608 | United States |
| Emory Children's Center | Atlanta | Georgia | 30329 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| National Institutes of Health | Bethesda | Maryland | 20892 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48912 | United States |
| Children's Hospital and Clinic Minnesota | Saint Paul | Minnesota | 55102 | United States |
| St. Joseph's University Medical Center | Paterson | New Jersey | 07503 | United States |
| NYU Winthrop Hospital | Mineola | New York | 11501 | United States |
| The Research Institute at Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Vanderbilt University | Nashville | Tennessee | 37212 | United States |
| Research Institute of Dallas | Dallas | Texas | 75231 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| Seattle Children's | Seattle | Washington | 98105 | United States |
| Fulbourn Hospital | Cambridge | CB21 5EF | United Kingdom |
| The Queen Elizabeth University | Glasgow | G51 4TF | United Kingdom |
| Hull and East Yorkshire Hospitals NHS Trust | Hull | HU3 2JZ | United Kingdom |
| Royal London Hospital | London | E1 1BB | United Kingdom |
| Chelsea and Westminster Hospital | London | SW10 9NH | United Kingdom |
| 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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