Clinical efficacy of ropinirole for restless legs syndrome is not affected by age at symptom onset.

OBJECTIVE: To determine whether clinical response to the dopamine agonist, ropinirole, in the treatment of primary restless legs syndrome (RLS), depends upon the age-at-onset of RLS symptoms. METHODS: Pooled data from four 12-week, randomized, double-blind, placebo-controlled studies of ropinirole in patients with moderate-to-severe primary RLS were analyzed post hoc. The relationship between age-at-onset and response to treatment, based on change from the baseline International Restless Legs Syndrome Study Group (IRLSSG) rating scale (the International Restless Legs Scale [IRLS]) total score and the proportion of responders (rated 'much'/'very much' improved) on the Clinical Global Impression-Improvement (CGI-I) scale, was explored. RESULTS: The range of age-at-onset of RLS symptoms was 2-75 years. No relationship was observed between the age-at-onset of RLS symptoms and baseline IRLS total score (correlation r=-0.06), and between dose administered at Week 12 last observation carried forward (LOCF) and age-at-onset (r=-0.04). The age-at-onset by treatment interaction was non-significant (P=0.952 for the IRLS and P=0.716 for the CGI-I scale), indicating there was no significant relationship between age-at-onset and the magnitude of ropinirole treatment effect. CONCLUSIONS: These data suggest that ropinirole provides effective relief of symptoms, regardless of age at RLS symptom onset.

Ropinirole in the treatment of patients with restless legs syndrome: a US-based randomized, double-blind, placebo-controlled clinical trial.

OBJECTIVE: To assess the efficacy, safety, and tolerability of the dopamine agonist ropinirole in the treatment of patients with moderate to severe primary restless legs syndrome (RLS). PATIENTS AND METHODS: This multicenter, 12-week, double-blind, placebo-controlled, flexible-dose study enrolled US patients and was conducted between September 2003 and May 2004. Patients were randomized to ropinirole or placebo, 0.25-4.0 mg as needed and tolerated, once daily, 1 to 3 hours before bedtime. The primary end point was mean change from baseline to week 12 in International Restless Legs Scale (IRLS) total score. Key secondary efficacy measures included the Clinical Global Impression-Improvement scale. RESULTS: A total of 381 patients were enrolled; 164 (87.7%) of 187 patients randomized to ropinirole and 167 (86.1%) of 194 randomized to placebo completed the study. Significant treatment differences favoring ropinirole, compared with placebo, were observed for change in IRLS total score at week 12 (adjusted mean treatment difference, -3.7; 95% confidence interval, -5.4 to -2.0; P < .001) and for all 3 key secondary end points: mean change from baseline in IRLS total score at week 1 and proportion of patients who were much/very much improved on the Clinical Global Impression Improvement scale at weeks 1 and 12. Ropinirole was associated with significantly greater Improvements in subjective measures of sleep disturbance, quantity, and adequacy; quality of life; and anxiety. Although treatment differences favoring ropinirole in daytime somnolence were observed, they were not statistically significant (P = .10). Ropinirole was generally well tolerated, with an adverse-event profile consistent with other dopamine agonists. CONCLUSION: This study confirms that ropinirole improves RLS symptoms and subjective measures of sleep, quality of life, and anxiety and that it is generally well tolerated.

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.