| Outcome Measures: |
Primary: International Restless Legs Syndrome Study Group Rating Scale (IRLS), The IRLS is a measure of severity of Restless Legs Syndrome. It includes 10 items, measured on a scale of 0-4. A score of 1-10 indicates mild severity, 11-20 indicates moderate severity, 21-30 is severe and 31-40 is very severe. Primary outcome is the difference in IRLS scores for each of the treatment regimens., 18 weeks (Baseline, Run-In, Follow-up) | Secondary: Restless Legs Syndrome-6 Scale (RLS-6), The RLS-6 is a measure of severity of Restless Legs Syndrome for the past week. It includes 6 items, measured on a scale of 0-10. Each item is measured from no symptoms (score of 0) to very severe symptoms (score of 10). Secondary outcome is the difference in RLS-6 scores for each of the treatment regimens., 18 weeks (Baseline, Run-In, Follow-up)|Patient Global Impressions (PGI), The PGI is a measure of Restless Legs Syndrome symptom severity. It includes 1 item, measured on a scale of 1-7. 1 indicates mild severity, 3 indicates moderate severity, 5 is severe and 7 is very severe. Secondary outcome is the difference in PGI scores for each of the treatment regimens, 18 weeks (Baseline, Run-In, Follow-up)|Euro-Quality of Life Scale (EQ-5D-5L), The EQ-5D-5L is a measure of health status. It includes 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and a visual analogue scale of 0-100 (0 being worst health and 100 being best health). The scale is measured by levels. Level 1 indicating no problems, 2 indicating slight problems, 3 indicating moderate problems, 4 indicating severe problems and 5 indicating extreme problems. Secondary outcome is the difference in EQ-5D-5L scores for each of the treatment regimens, 18 weeks (Baseline, Run-In, Follow-up)|Incidence of falls, fractures and hospitalizations/emergency room visits due to altered level of consciousness., The total number of falls, fractures, or hospitalization/emergency rooms visits due to confusion/delirium or altered mental state., 18 weeks (Baseline, Run-In, Follow-up)
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| Locations: |
Nova Scotia Health Authority, Halifax, Nova Scotia, B3H 2Y9, Canada|St. Joseph's Hamilton Healthcare, Hamilton, Ontario, L8N 4A6, Canada|The Ottawa Hospital, Ottawa, Ontario, K1H 7W9, Canada
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