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The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropinirole Extended Release (XR) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assess safety, tolerability, and patient-reported outcomes, including changes in the Clinical Global Impression Scale Scores and changes in the Medical Outcomes Study Sleep Scale at Week 12. | 12 Weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Alabaster | Alabama | 35007 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 101468/205 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Jasper |
| Alabama |
| 35501 |
| United States |
| GSK Investigational Site | Mesa | Arizona | 85201 | United States |
| GSK Investigational Site | Peoria | Arizona | 85381 - 4828 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85032 | United States |
| GSK Investigational Site | Sun City | Arizona | 85351 | United States |
| GSK Investigational Site | Anaheim | California | 92801 | United States |
| GSK Investigational Site | Northridge | California | 91325 | United States |
| GSK Investigational Site | Oxnard | California | 93030 | United States |
| GSK Investigational Site | Pasadena | California | 91105 | United States |
| GSK Investigational Site | Redondo Beach | California | 90277 | United States |
| GSK Investigational Site | San Diego | California | 92103 | United States |
| GSK Investigational Site | Santa Monica | California | 90404 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80909 | United States |
| GSK Investigational Site | Denver | Colorado | 80212 | United States |
| GSK Investigational Site | Wheat Ridge | Colorado | 80033 | United States |
| GSK Investigational Site | Largo | Florida | 33773 | United States |
| GSK Investigational Site | Pembroke Pines | Florida | 33026 | United States |
| GSK Investigational Site | Stuart | Florida | 34996 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30338 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Austell | Georgia | 30106 | United States |
| GSK Investigational Site | Dawsonville | Georgia | 30534 | United States |
| GSK Investigational Site | Macon | Georgia | 31201 | United States |
| GSK Investigational Site | Woodstock | Georgia | 30189 | United States |
| GSK Investigational Site | Northbrook | Illinois | 60062 | United States |
| GSK Investigational Site | Lenexa | Kansas | 66214 | United States |
| GSK Investigational Site | Topeka | Kansas | 66606 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40217 | United States |
| GSK Investigational Site | Baton Rouge | Louisiana | 70808 | United States |
| GSK Investigational Site | Newton | Massachusetts | 02459 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89119 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87108 | United States |
| GSK Investigational Site | Albany | New York | 12205 | United States |
| GSK Investigational Site | Endwell | New York | 13760 | United States |
| GSK Investigational Site | Kingston | New York | 12401 | United States |
| GSK Investigational Site | Schenectady | New York | 12308 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45236 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44130 | United States |
| GSK Investigational Site | Dublin | Ohio | 43017 | United States |
| GSK Investigational Site | Westerville | Ohio | 43081 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| GSK Investigational Site | Portland | Oregon | 97219 | United States |
| GSK Investigational Site | Lafayette Hill | Pennsylvania | 19444 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29201 | United States |
| GSK Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| GSK Investigational Site | Jackson | Tennessee | 38305 | United States |
| GSK Investigational Site | Dallas | Texas | 75231 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84102 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84121 | United States |
| GSK Investigational Site | Alexandria | Virginia | 22311 | United States |
| GSK Investigational Site | Charlottesville | Virginia | 22911 | United States |
| GSK Investigational Site | Bellingham | Washington | 98226 | United States |
| GSK Investigational Site | Renton | Washington | 98055 | United States |
| GSK Investigational Site | Spokane | Washington | 99204 | United States |
| GSK Investigational Site | Walla Walla | Washington | 99362 | United States |
| GSK Investigational Site | Wenatchee | Washington | 98801 | United States |
| GSK Investigational Site | Edmonton | Alberta | T6G 2C8 | Canada |
| GSK Investigational Site | Coquitlam | British Columbia | V3K 3P4 | Canada |
| GSK Investigational Site | Langley | British Columbia | V3A 4H9 | Canada |
| GSK Investigational Site | Halifax | Nova Scotia | B3J 3T1 | Canada |
| GSK Investigational Site | Ajax | Ontario | L1S 2J5 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2T 2N6 | Canada |
| GSK Investigational Site | Montreal | Quebec | H4J 1C5 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| GSK Investigational Site | Trois-Rivières | Quebec | G8Z 4K4 | Canada |
| GSK Investigational Site | Regina | Saskatchewan | S4P 0W5 | Canada |
For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/205 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/205 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/205 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/205 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/205 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 101468/205 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
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