Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropinirole CR-RLS | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 12 Change from baseline in sleep Latency at Week 12. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes. | 12 Weeks |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Jasper | Alabama | 35501 | United States | ||
| GSK Investigational Site |
Not provided
| 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 |
|---|---|---|---|
| RRL103660 | 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.
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 8, 2017 | |
| Unrelease | Aug 15, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tuscaloosa |
| Alabama |
| 35406 |
| United States |
| GSK Investigational Site | Phoenix | Arizona | 85006 | United States |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | United States |
| GSK Investigational Site | Anaheim | California | 92801 | United States |
| GSK Investigational Site | San Diego | California | 92108 | United States |
| GSK Investigational Site | Greenwood | Colorado | 80111 | United States |
| GSK Investigational Site | Wheat Ridge | Colorado | 80033 | United States |
| GSK Investigational Site | Brandon | Florida | 33511 | United States |
| GSK Investigational Site | Pembroke Pines | Florida | 33026 | United States |
| GSK Investigational Site | St. Petersburg | Florida | 33707 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Austell | Georgia | 30106 | United States |
| GSK Investigational Site | Macon | Georgia | 31201 | United States |
| GSK Investigational Site | Elk Grove Village | Illinois | 60007 | United States |
| GSK Investigational Site | Normal | Illinois | 61761 | United States |
| GSK Investigational Site | Danville | Indiana | 46122 | United States |
| GSK Investigational Site | Lenexa | Kansas | 66214 | United States |
| GSK Investigational Site | Topeka | Kansas | 66606 | United States |
| GSK Investigational Site | Crestview Hills | Kentucky | 41017 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40509 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40217 | United States |
| GSK Investigational Site | Baton Rouge | Louisiana | 70808 | United States |
| GSK Investigational Site | Lafayette | Louisiana | 70503 | United States |
| GSK Investigational Site | Auburn | Maine | 04210 | United States |
| GSK Investigational Site | Brighton | Massachusetts | 02135 | United States |
| GSK Investigational Site | St Louis | Missouri | 63143 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89104 | United States |
| GSK Investigational Site | Toms River | New Jersey | 08755 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28204 | United States |
| GSK Investigational Site | Greenville | North Carolina | 27835 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45246 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44195 | United States |
| GSK Investigational Site | Dublin | Ohio | 43017 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| GSK Investigational Site | Tulsa | Oklahoma | 74104 | United States |
| GSK Investigational Site | Corvallis | Oregon | 97330 | United States |
| GSK Investigational Site | Portland | Oregon | 97219 | United States |
| GSK Investigational Site | Portland | Oregon | 97239 | United States |
| GSK Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| GSK Investigational Site | Lafayette Hill | Pennsylvania | 19444 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29201 | United States |
| GSK Investigational Site | Dallas | Texas | 75213 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Walla Walla | Washington | 99362 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| RRL103660 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| RRL103660 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| RRL103660 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| RRL103660 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| RRL103660 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| RRL103660 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 8, 2017 | Aug 15, 2018 |
| 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 |
Not provided
Not provided