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

• Published in: Journal of neurology, neurosurgery and psychiatry Vol. 75; no. 1; pp. 92 - 97
• Main Authors: Trenkwalder, C, Garcia-Borreguero, D, Montagna, P, Lainey, E, de Weerd, A W, Tidswell, P, Saletu-Zyhlarz, G, Telstad, W, Ferini-Strambi, L
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group Ltd 01.01.2004; BMJ; BMJ Publishing Group LTD; BMJ Group
• Subjects: 36 item short form health survey; Adult; Aged; Biological and medical sciences; CGI; CGI-I; clinical global impression; clinical global impression–global improvement scale; Dopamine; Dopamine Agonists - adverse effects; Dopamine Agonists - pharmacology; Dopamine Agonists - therapeutic use; Double-Blind Method; Drug dosages; Female; Headache - chemically induced; Humans; Indoles - adverse effects; Indoles - pharmacology; Indoles - therapeutic use; intention to treat; international restless legs scale; International Restless Legs Syndrome Study Group; IRLS; IRLSSG; ITT; Male; medical outcomes study; Medical sciences; Middle Aged; MOS; Nausea - chemically induced; Neurology; Patients; Placebos; Prospective Studies; QoL; Quality of Life; randomised controlled trial; Restless legs syndrome; Restless Legs Syndrome - drug therapy; RLS; ropinirole; Severity of Illness Index; SF-36; Sleep; Substance abuse treatment; Treatment Outcome; work productivity and activity impairment; WPAI; Sensitivity disorder; Restless legs syndrome; Ropinirole; Nervous system diseases; Treatment; Countries; Neurological disorder
• ISSN: 0022-3050; 1468-330X

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 ⩾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.