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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

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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
  1. C Trenkwalder1,
  2. D Garcia-Borreguero2,
  3. P Montagna3,
  4. E Lainey4,
  5. A W de Weerd5,
  6. P Tidswell6,
  7. G Saletu-Zyhlarz7,
  8. W Telstad8,
  9. L Ferini-Strambi9,
  10. on behalf of the TREAT RLS 1 (Therapy with Ropinirole; Efficacy And Tolerability in RLS 1) Study Group*
  1. 1Paracelsus-Elena-Klinik, University of Göttingen, Göttingen, Germany
  2. 2Department of Neurology, Fundación Jiménez Díaz, Madrid, Spain
  3. 3Department of Neurological Sciences, Università Degli Studi Di Bologna, Bologna, Italy
  4. 4Hôpital Européen Georges Pompidou, Consultation Sommeil, Service de Psychologie Clinique et de Psychiatrie de Liaison, Paris, France
  5. 5Medisch Centrum Haaglanden Locatie Westeinde, Centrum voor Slaap-en Waakstoornissen, Den Haag, Netherlands
  6. 6Chorley Clinical Research Centre, Synexus Ltd, Chorley, Lancashire, UK
  7. 7Department of Psychiatry, University of Vienna, Vienna, Austria
  8. 8Nevrologisk Poliklinikk, Sentralsjukehuset i Sogn og Fjordane, Førde, Norway
  9. 9Sleep Disorders Centre, Università Vita-Salute San Raffaele, Milano, Italy
  1. Correspondence to:
 Professor C Trenkwalder
 Department of Clinical Neurophysiology, University of Goettingen, Robert-Koch-Str. 40, D-37075 Goettingen, Germany; ctrenkwgwdg.de

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 ⩾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.

  • restless legs syndrome
  • ropinirole
  • randomised controlled trial
  • CGI, clinical global impression
  • CGI-I, clinical global impression–global improvement scale
  • IRLS, international restless legs scale
  • IRLSSG, International Restless Legs Syndrome Study Group
  • ITT, intention to treat
  • MOS, medical outcomes study
  • QoL, quality of life
  • RLS, restless legs syndrome
  • SF-36, 36 item short form health survey
  • WPAI, work productivity and activity impairment

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    Footnotes

    • ↵* A full list of the members of the TREAT RLS 1 Study Group is given in the appendix.

    • Competing interests: PT has received sponsorship from GSK and other pharmaceutical companies marketing dopamine agonists to attend international meetings, and has been an investigator in clinical trials of dopamine agonists in Parkinson’s disease. CT has received honoraria for educational lectures and consultancy fees from GSK, Eli Lilly, and Boehringer Ingelheim. No other authors have any disclosures to make.