Ropinirole is effective in the long-term management of restless legs syndrome: A randomized controlled trial

✍ Scribed by Jacques Montplaisir; Jeff Karrasch; Jean Haan; Dieter Volc

• Publisher: John Wiley and Sons
• Year: 2006
• Tongue: English
• Weight: 302 KB
• Volume: 21
• Category: Article
• ISSN: 0885-3185
• DOI: 10.1002/mds.21050

✦ Synopsis

Abstract

The objective of this study was to investigate the long‐term efficacy of ropinirole in patients with restless legs syndrome (RLS) and to assess the potential for relapse after the discontinuation of active treatment. Patients with primary RLS (n = 202) received single‐blind ropinirole for 24 weeks. Patients meeting treatment continuation criteria were randomized to double‐blind treatment with ropinirole or placebo for a further 12 weeks. The primary efficacy variable was the proportion of patients relapsing during double‐blind treatment. Additional efficacy measures included time to relapse, withdrawals due to lack of efficacy, improvement on the Clinical Global Impression–Improvement (CGI‐I) scale, change in International Restless Legs Scale (IRLS) score during double‐blind treatment, and changes in sleep and quality of life (QoL) parameters. Significantly fewer patients relapsed on ropinirole than on placebo (32.6% vs. 57.8%; P = 0.0156). Time to relapse was longer with ropinirole and more patients withdrew due to lack of efficacy with placebo. Patients showed improvements in IRLS and CGI‐I scores, sleep and QoL parameters with single‐blind ropinirole, which were better maintained when ropinirole was continued during the double‐blind phase, but reduced with placebo. Ropinirole was well tolerated; adverse events were typical for dopamine agonists. Ropinirole was highly effective and well tolerated in the long‐term management of RLS, with pharmacological effect over 36 weeks. © 2006 Movement Disorder Society