OBJECTIVES: To investigate the effect of twice-daily ropinirole in patients with early evening restless legs syndrome (RLS) symptoms, particularly focusing on the relationship of patient- and physician-rated assessment of treatment outcomes. METHODS: In this multicenter, double-blind, randomized, 12-week, flexible-dose study, patients with primary RLS, with symptom onset no earlier than 5 PM and a baseline International Restless Legs Syndrome Study Group Rating Scale (IRLS) total score > or = 20 received ropinirole 0.5 to 6.0 mg/d twice daily in equally divided doses, or placebo. First dose was 1 hour before the usual onset of symptoms; second dose was 3 to 8 hours after the first. Primary end point: change from baseline in IRLS total score at week 12 last observation carried forward (LOCF). Key secondary end points: proportion of responders (rated "very much improved" or "much improved") on the Clinical Global Impression-Improvement and the Patient Global Improvement scales. RESULTS: Improvements in IRLS total score were statistically significantly greater for ropinirole (n = 175), compared with placebo (n = 184) at all assessment points beginning at day 3 through to week 12 LOCF (P < 0.001). A statistically significantly greater proportion of patients were classified as responders on the Clinical Global Impression-Improvement scale at all assessment points from day 3 through week 12 LOCF (P < 0.001) and on the Patient Global Improvement scale at all assessment points from day 1 (P = 0.013) through day 7 LOCF (P < or = 0.05 for days 2-7 LOCF) and at week 12 LOCF (P < 0.001). CONCLUSIONS: Ropinirole is associated with consistent early and sustained improvements in the symptoms of RLS, as rated by patients and physicians.
RCT Entities:
OBJECTIVES: To investigate the effect of twice-daily ropinirole in patients with early evening restless legs syndrome (RLS) symptoms, particularly focusing on the relationship of patient- and physician-rated assessment of treatment outcomes. METHODS: In this multicenter, double-blind, randomized, 12-week, flexible-dose study, patients with primary RLS, with symptom onset no earlier than 5 PM and a baseline International Restless Legs Syndrome Study Group Rating Scale (IRLS) total score > or = 20 received ropinirole 0.5 to 6.0 mg/d twice daily in equally divided doses, or placebo. First dose was 1 hour before the usual onset of symptoms; second dose was 3 to 8 hours after the first. Primary end point: change from baseline in IRLS total score at week 12 last observation carried forward (LOCF). Key secondary end points: proportion of responders (rated "very much improved" or "much improved") on the Clinical Global Impression-Improvement and the Patient Global Improvement scales. RESULTS: Improvements in IRLS total score were statistically significantly greater for ropinirole (n = 175), compared with placebo (n = 184) at all assessment points beginning at day 3 through to week 12 LOCF (P < 0.001). A statistically significantly greater proportion of patients were classified as responders on the Clinical Global Impression-Improvement scale at all assessment points from day 3 through week 12 LOCF (P < 0.001) and on the Patient Global Improvement scale at all assessment points from day 1 (P = 0.013) through day 7 LOCF (P < or = 0.05 for days 2-7 LOCF) and at week 12 LOCF (P < 0.001). CONCLUSIONS:Ropinirole is associated with consistent early and sustained improvements in the symptoms of RLS, as rated by patients and physicians.
Authors: R Nisha Aurora; David A Kristo; Sabin R Bista; James A Rowley; Rochelle S Zak; Kenneth R Casey; Carin I Lamm; Sharon L Tracy; Richard S Rosenberg Journal: Sleep Date: 2012-08-01 Impact factor: 5.849
Authors: Qinbo Yang; Lin Li; Qiuyun Chen; Nancy Foldvary-Schaefer; William G Ondo; Qing Kenneth Wang Journal: Sleep Med Date: 2011-09 Impact factor: 3.492