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Ropinirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study, a 12 week, randomised, placebo controlled study in 10 European countries.
J Neurol Neurosurg Psychiatry. 2004 Jan; 75(1):92-7.JN

Abstract

OBJECTIVE

To assess the efficacy, safety, and tolerability of ropinirole in the treatment of patients with restless legs syndrome.

METHODS

A 12 week, prospective, double blind, randomised comparison involving 284 patients from 10 European countries. All participants had a score of > or =15 on the international restless legs scale (IRLS). Patients were randomised (1:1) to receive either ropinirole 0.25-4.0 mg once daily or placebo. The primary efficacy end point was mean change from baseline to week 12 in total IRLS score. Global improvements (clinical global impression (CGI) scale) and improvements in sleep, health related quality of life (QoL; using generic and disease specific measures), work, and other activities were also assessed.

RESULTS

112/146 patients (76.7%) taking ropinirole and 109/138 (79.0%) taking placebo completed the study. Improvement in IRLS at week 12 with ropinirole (mean (SD) dose, 1.90 (1.13) mg/day) was greater than with placebo (mean (SE): -11.04 (0.719) v -8.03 (0.738) points; adjusted difference = -3.01 (95% confidence interval (CI), -5.03 to -0.99); p = 0.0036). More patients in the ropinirole group (53.4%) showed improvement on the CGI scale at week 12 than in the placebo group (40.9%; adjusted odds ratio = 1.7 (1.02 to 2.69); p = 0.0416). Significant differences on both IRLS and CGI scales favouring ropinirole were apparent by week 1. Ropinirole was also associated with significantly greater improvements in sleep and QoL end points. The most common adverse events were nausea and headache.

CONCLUSIONS

Ropinirole improves restless legs syndrome compared with placebo, with benefits apparent by week 1. It is generally well tolerated.

Authors+Show Affiliations

Department of Clinical Neurophysiology, Paracelsus-Elena-Klinik, University of Göttingen, Göttingen, Germany. ctrenkw@gwdg.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

14707315

Citation

Trenkwalder, C, et al. "Ropinirole in the Treatment of Restless Legs Syndrome: Results From the TREAT RLS 1 Study, a 12 Week, Randomised, Placebo Controlled Study in 10 European Countries." Journal of Neurology, Neurosurgery, and Psychiatry, vol. 75, no. 1, 2004, pp. 92-7.
Trenkwalder C, Garcia-Borreguero D, Montagna P, et al. Ropinirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study, a 12 week, randomised, placebo controlled study in 10 European countries. J Neurol Neurosurg Psychiatry. 2004;75(1):92-7.
Trenkwalder, C., Garcia-Borreguero, D., Montagna, P., Lainey, E., de Weerd, A. W., Tidswell, P., Saletu-Zyhlarz, G., Telstad, W., & Ferini-Strambi, L. (2004). Ropinirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study, a 12 week, randomised, placebo controlled study in 10 European countries. Journal of Neurology, Neurosurgery, and Psychiatry, 75(1), 92-7.
Trenkwalder C, et al. Ropinirole in the Treatment of Restless Legs Syndrome: Results From the TREAT RLS 1 Study, a 12 Week, Randomised, Placebo Controlled Study in 10 European Countries. J Neurol Neurosurg Psychiatry. 2004;75(1):92-7. PubMed PMID: 14707315.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ropinirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study, a 12 week, randomised, placebo controlled study in 10 European countries. AU - Trenkwalder,C, AU - Garcia-Borreguero,D, AU - Montagna,P, AU - Lainey,E, AU - de Weerd,A W, AU - Tidswell,P, AU - Saletu-Zyhlarz,G, AU - Telstad,W, AU - Ferini-Strambi,L, AU - ,, PY - 2004/1/7/pubmed PY - 2004/2/5/medline PY - 2004/1/7/entrez SP - 92 EP - 7 JF - Journal of neurology, neurosurgery, and psychiatry JO - J. Neurol. Neurosurg. Psychiatry VL - 75 IS - 1 N2 - OBJECTIVE: To assess the efficacy, safety, and tolerability of ropinirole in the treatment of patients with restless legs syndrome. METHODS: A 12 week, prospective, double blind, randomised comparison involving 284 patients from 10 European countries. All participants had a score of > or =15 on the international restless legs scale (IRLS). Patients were randomised (1:1) to receive either ropinirole 0.25-4.0 mg once daily or placebo. The primary efficacy end point was mean change from baseline to week 12 in total IRLS score. Global improvements (clinical global impression (CGI) scale) and improvements in sleep, health related quality of life (QoL; using generic and disease specific measures), work, and other activities were also assessed. RESULTS: 112/146 patients (76.7%) taking ropinirole and 109/138 (79.0%) taking placebo completed the study. Improvement in IRLS at week 12 with ropinirole (mean (SD) dose, 1.90 (1.13) mg/day) was greater than with placebo (mean (SE): -11.04 (0.719) v -8.03 (0.738) points; adjusted difference = -3.01 (95% confidence interval (CI), -5.03 to -0.99); p = 0.0036). More patients in the ropinirole group (53.4%) showed improvement on the CGI scale at week 12 than in the placebo group (40.9%; adjusted odds ratio = 1.7 (1.02 to 2.69); p = 0.0416). Significant differences on both IRLS and CGI scales favouring ropinirole were apparent by week 1. Ropinirole was also associated with significantly greater improvements in sleep and QoL end points. The most common adverse events were nausea and headache. CONCLUSIONS: Ropinirole improves restless legs syndrome compared with placebo, with benefits apparent by week 1. It is generally well tolerated. SN - 0022-3050 UR - https://www.unboundmedicine.com/medline/citation/14707315/Ropinirole_in_the_treatment_of_restless_legs_syndrome:_results_from_the_TREAT_RLS_1_study_a_12_week_randomised_placebo_controlled_study_in_10_European_countries_ L2 - http://jnnp.bmj.com/cgi/pmidlookup?view=long&pmid=14707315 DB - PRIME DP - Unbound Medicine ER -