Efficacy and tolerability of ropinirole in patients with restless legs syndrome and a baseline IRLS total score > or = 24 points--data from the ropinirole clinical trial programme.

OBJECTIVE: Results from one of the largest clinical trial programmes to date of a dopamine agonist in patients with primary restless legs syndrome (RLS) have demonstrated that ropinirole, 0.25-4.0 mg once daily 1-3 hours before bedtime, is associated with significant improvements in RLS symptoms, sleep parameters and quality-of-life measures, compared with placebo. Analyses were conducted in a subpopulation of patients with a baseline score on the International Restless Legs Scale (IRLS) of at least 24 points. RESEARCH DESIGN AND METHODS: Data was pooled from four, 12-week, pivotal studies: RESET PLM and TREAT RLS 1, 2 and US. MAIN OUTCOME MEASURES: Covariate analysis demonstrated that the magnitude of treatment difference between ropinirole and placebo for change in IRLS total score (a measure of RLS symptom severity) increased with increasing baseline IRLS total score. Mean treatment difference was > 3 points in patients with a baseline total score > or = 24. Among this population, ropinirole treatment was associated with significant reduction in RLS symptom severity compared with placebo, along with significant improvements in global symptoms and sleep measures. A treatment benefit was also observed for measures of quality of life. Ropinirole is well tolerated in this patient population. CONCLUSIONS: Patients with primary RLS and baseline IRLS total score > or = 24 gain clinically meaningful benefits from ropinirole treatment. As with the overall population in the ropinirole clinical trial programme, ropinirole was associated with improvements in RLS symptoms, global symptoms, sleep and quality of life and was well tolerated in patients with a baseline IRLS total score > or = 24.

The reliability, validity and responsiveness of the International Restless Legs Syndrome Study Group rating scale and subscales in a clinical-trial setting.

PATIENTS AND METHODS: To assess the reliability, validity, and responsiveness of the International Restless Legs Syndrome Study Group's rating scale (the International Restless Legs Scale (IRLS)) (V2.0), using pooled data from two matching, placebo-controlled studies of ropinirole for treating Restless Legs Syndrome (RLS). RESULTS: Pooled patient samples comprised 550 patients in the baseline (validation) sample and 439 patients in the week 12 longitudinal (responsiveness) sample. Factor analysis revealed acceptability of the IRLS total score (accounting for 40% of the variance) and that nine of the 10 IRLS items could also be assigned to two distinct subscales, the symptoms or symptoms impact subscales. The IRLS total score, symptoms and symptoms impact subscales had acceptable construct validity, internal consistency reliability (alpha=0.81, 0.80, and 0.76, respectively), and concurrent validity (r=-0.68, -0.52, -0.70, respectively, with the Restless Legs Syndrome Quality of Life questionnaire (RLSQoL) overall life impact score). IRLS scores differed significantly between different levels of sleep problems and Clinical Global Impression (CGI) of health status (P<0.0001), indicating known groups and clinical validity, respectively. Changes in scores differed significantly among CGI 'global improvement' levels (P<0.0001), providing evidence of responsiveness. CONCLUSIONS: The IRLS total score, symptoms, and symptoms impact subscales are reliable, valid, and responsive in a clinical trial setting.