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A 12-week clinical research study to evaluate the tolerability, efficacy and safety of ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with RLS in the United States.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropinirole | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication. | 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 |
|---|---|---|---|
| 100310 | Statistical Analysis Plan | 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 | Peoria | Arizona | 85381 - 4828 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85032 | United States |
| GSK Investigational Site | Northridge | California | 91325 | United States |
| GSK Investigational Site | Oxnard | California | 93030 | United States |
| GSK Investigational Site | Redondo Beach | California | 90277 | United States |
| GSK Investigational Site | Santa Monica | California | 90404 | United States |
| GSK Investigational Site | Fairfield | Connecticut | 06824 | United States |
| GSK Investigational Site | Largo | Florida | 33773 | United States |
| GSK Investigational Site | Pembroke Pines | Florida | 33026 | United States |
| GSK Investigational Site | St. Petersburg | Florida | 33701 | United States |
| GSK Investigational Site | Tampa | Florida | 33606 | United States |
| GSK Investigational Site | Chicago | Illinois | 60611 | United States |
| GSK Investigational Site | Elk Grove Village | Illinois | 60007 | United States |
| GSK Investigational Site | Flossmoor | Illinois | 60422 | United States |
| GSK Investigational Site | Topeka | Kansas | 66606 | United States |
| GSK Investigational Site | Baton Rouge | Louisiana | 70808 | United States |
| GSK Investigational Site | Frederick | Maryland | 21702 | United States |
| GSK Investigational Site | Newton | Massachusetts | 02459 | United States |
| GSK Investigational Site | Newton Center | Massachusetts | 02459 | United States |
| GSK Investigational Site | Bingham Farms | Michigan | 48025 | United States |
| GSK Investigational Site | Edison | New Jersey | 08818 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87106 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87108 | United States |
| GSK Investigational Site | Amherst | New York | 14226 | United States |
| GSK Investigational Site | New Hyde Park | New York | 11040 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | United States |
| GSK Investigational Site | Concinnati | Ohio | 45219 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| GSK Investigational Site | Lafayette Hill | Pennsylvania | 19444 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29201 | United States |
| GSK Investigational Site | Austin | Texas | 78756 | United States |
| GSK Investigational Site | Plano | Texas | 75093 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Walla Walla | Washington | 99362 | United States |
| GSK Investigational Site | Wenatchee | Washington | 98801 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| 100310 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100310 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100310 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100310 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100310 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100310 | Study Protocol | 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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| ID | Term |
|---|---|
| C046649 | ropinirole |
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