A 52-week open-label study of the long-term safety of ropinirole in patients with restless legs syndrome.

Author(s): Garcia-Borreguero D, Grunstein R, Sridhar G, Dreykluft T, Montagna P, Dom R, Lainey E, Moorat A, Roberts J

Affiliation(s): Sleep Research Institute, Alberto Alcocer 19, 28036 Madrid, Spain. dgb@iis.es

Publication date & source: 2007-11, Sleep Med., 8(7-8):742-52. Epub 2007 May 18.

Publication type: Clinical Trial; Multicenter Study; Research Support, Non-U.S. Gov't

OBJECTIVE: To assess the long-term safety and efficacy of ropinirole in the treatment of patients with restless legs syndrome (RLS) over 52 weeks. METHODS: A 52-week, multicentre, open-label continuation study involving 310 patients, conducted in 11 countries. Eligible patients from four parent studies were invited to participate. At parent study entry, all patients had a score of > or =15 on the International Restless Legs Scale (IRLS). In this continuation study, all participants received ropinirole, 0.25-4.0 mg once daily, for 52 weeks. The primary study objective was to evaluate the safety of ropinirole. Efficacy was assessed by change in IRLS score, as well as by global improvements (clinical global impression [CGI] scale) and improvements in measures of sleep, work productivity, and quality of life. RESULTS: Overall, 251 (81.0%) patients completed the study. The mean ropinirole dose at study end was 1.90 mg/day. A total of 282 patients (91.3%) reported > or = 1 adverse event. For the majority of patients, the reported adverse events were mild or moderate in intensity. The most common adverse event was nausea. Adverse events led to discontinuation in 8.7% of patients. At week 52, IRLS scores improved by an average of 12.0 points from baseline, and 82.8% of patients were 'much improved' or 'very much improved' on the CGI-improvement scale. Ropinirole treatment was also associated with improvements in measures of sleep and quality of life. CONCLUSIONS: Ropinirole was well tolerated and therapeutic efficacy was maintained over 52 weeks in patients with RLS.