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Ropinirole is effective in the long-term management of restless legs syndrome: a randomized controlled trial.
Mov Disord. 2006 Oct; 21(10):1627-35.MD

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+Show Affiliations

Sleep Disorders Clinic, Hôpital du Sacré-Coeur de Montréal, Montréal, Quebec, Canada. j-montplaisir@crhsc.umontreal.caNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16874755

Citation

Montplaisir, Jacques, et al. "Ropinirole Is Effective in the Long-term Management of Restless Legs Syndrome: a Randomized Controlled Trial." Movement Disorders : Official Journal of the Movement Disorder Society, vol. 21, no. 10, 2006, pp. 1627-35.
Montplaisir J, Karrasch J, Haan J, et al. Ropinirole is effective in the long-term management of restless legs syndrome: a randomized controlled trial. Mov Disord. 2006;21(10):1627-35.
Montplaisir, J., Karrasch, J., Haan, J., & Volc, D. (2006). Ropinirole is effective in the long-term management of restless legs syndrome: a randomized controlled trial. Movement Disorders : Official Journal of the Movement Disorder Society, 21(10), 1627-35.
Montplaisir J, et al. Ropinirole Is Effective in the Long-term Management of Restless Legs Syndrome: a Randomized Controlled Trial. Mov Disord. 2006;21(10):1627-35. PubMed PMID: 16874755.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ropinirole is effective in the long-term management of restless legs syndrome: a randomized controlled trial. AU - Montplaisir,Jacques, AU - Karrasch,Jeff, AU - Haan,Jean, AU - Volc,Dieter, PY - 2006/7/29/pubmed PY - 2007/2/3/medline PY - 2006/7/29/entrez SP - 1627 EP - 35 JF - Movement disorders : official journal of the Movement Disorder Society JO - Mov. Disord. VL - 21 IS - 10 N2 - 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. SN - 0885-3185 UR - https://www.unboundmedicine.com/medline/citation/16874755/Ropinirole_is_effective_in_the_long_term_management_of_restless_legs_syndrome:_a_randomized_controlled_trial_ L2 - https://doi.org/10.1002/mds.21050 DB - PRIME DP - Unbound Medicine ER -