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The named patient program will allow investigators to supply rotigotine transdermal system to patients who have a documented medical necessity to receive treatment with the drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotigotine | Patients who have a documented medical necessity to receive treatment with rotigotine treatment in accordance with standard medical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine patch | Drug | 1 patch daily for up to 48 months. Patch strength (per 24 hours): 1 mg - 8 mg based on investigator's assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events as reported spontaneously by the subject or as assessed by the investigator at the maintenance visits (about every three months) | Adverse events as reported spontaneously by the subject or as assessed by the investigator at the maintenance visits (about every three months) | From Baseline to End of Study (up to 48 months) |
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Inclusion Criteria:
Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent
Subject is willing and able to comply with all trial requirements
Subject either:
The investigator attests to the medical necessity of treatment with Rotigotine in contrast to alternate treatments (eg, dysphagia).
The investigator receives written approval from the Sponsor to enroll the subject
Exclusion Criteria:
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Patients who have a documented medical necessity to receive treatment with rotigotine treatment in accordance with standard medical practice.
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 088 | Birmingham | Alabama | United States | |||
| 082 |
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| Cullman |
| Alabama |
| United States |
| 085 | Fairhope | Alabama | United States |
| 014 | Huntsville | Alabama | United States |
| 097 | Gilbert | Arizona | United States |
| 003 | Phoenix | Arizona | United States |
| 044 | Phoenix | Arizona | United States |
| 036 | Berkeley | California | United States |
| 024 | Fountain Valley | California | United States |
| 034 | Irvine | California | United States |
| 019 | Los Angeles | California | United States |
| 040 | Orange | California | United States |
| 076 | Sunnyvale | California | United States |
| 035 | Fort Collins | Colorado | United States |
| 027 | Washington D.C. | District of Columbia | United States |
| 070 | Atlantis | Florida | United States |
| 002 | Boca Raton | Florida | United States |
| 031 | Clearwater | Florida | United States |
| 028 | Largo | Florida | United States |
| 075 | Ormond Beach | Florida | United States |
| 022 | St. Petersburg | Florida | United States |
| 004 | Tampa | Florida | United States |
| 054 | Weston | Florida | United States |
| 030 | Atlanta | Georgia | United States |
| 041 | Honolulu | Hawaii | United States |
| 011 | Peoria | Illinois | United States |
| 025 | Destrehan | Louisiana | United States |
| 091 | Clinton Township | Michigan | United States |
| 001 | Southfield | Michigan | United States |
| 042 | Warren | Michigan | United States |
| 037 | Ocean Springs | Mississippi | United States |
| 016 | West Plains | Missouri | United States |
| 026 | Lincoln | Nebraska | United States |
| 086 | Freehold | New Jersey | United States |
| 062 | Ridgewood | New Jersey | United States |
| 018 | Albany | New York | United States |
| 066 | Brooklyn | New York | United States |
| 006 | Patchogue | New York | United States |
| 052 | Charlotte | North Carolina | United States |
| 093 | Salisbury | North Carolina | United States |
| 065 | Albany | Oregon | United States |
| 009 | Salem | Oregon | United States |
| 048 | Austin | Texas | United States |
| 072 | Austin | Texas | United States |
| 071 | Dallas | Texas | United States |
| 046 | Houston | Texas | United States |
| 005 | Kirkland | Washington | United States |
| 017 | Olympia | Washington | United States |
| 012 | Spokane | Washington | United States |
| 053 | Tacoma | Washington | United States |
| 056 | Milwaukee | Wisconsin | United States |