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

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.

• Authors: Jacques Montplaisir, Jeff Karrasch, Jean Haan, Dieter Volc (Affiliation: Sleep Disorders Clinic, Hôpital du Sacré-Coeur de Montréal, Montréal, Quebec, Canada. j-montplaisir at crhsc.umontreal.ca)
• Journal: Movement disorders : official journal of the Movement Disorder Society (Mov Disord) Vol. 21 Issue 10 Pg. 1627-35 (Oct 2006) ISSN: 0885-3185 [Print] United States
• PMID: 16874755 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Dopamine Agonists
• Indoles
• ropinirole

Topics

• Adolescent
• Adult
• Aged
• Dopamine Agonists (adverse effects, therapeutic use)
• Double-Blind Method
• Drug Therapy, Combination
• Drug Toxicity
• Female
• Humans
• Indoles (adverse effects, therapeutic use)
• Long-Term Care
• Male
• Middle Aged
• Restless Legs Syndrome (drug therapy)
• Single-Blind Method
• Treatment Outcome