title: 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.
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.affiliation: Department of Clinical Neurophysiology, Paracelsus-Elena-Klinik, University of Göttingen, Göttingen, Germany. ctrenkw@gwdg.de
authors.forename: C
authors.initials: C
authors.lastname: Trenkwalder
authors.forename: D
authors.initials: D
authors.lastname: Garcia-Borreguero
authors.forename: P
authors.initials: P
authors.lastname: Montagna
authors.forename: E
authors.initials: E
authors.lastname: Lainey
authors.forename: A W
authors.initials: AW
authors.lastname: de Weerd
authors.forename: P
authors.initials: P
authors.lastname: Tidswell
authors.forename: G
authors.initials: G
authors.lastname: Saletu-Zyhlarz
authors.forename: W
authors.initials: W
authors.lastname: Telstad
authors.forename: L
authors.initials: L
authors.lastname: Ferini-Strambi
mesh_terms: D000328:Adult; D000368:Aged; D018491:Dopamine Agonists / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010919:Placebos; D011446:Prospective Studies; D011788:Quality of Life; D012148:Restless Legs Syndrome / Q000188:drug therapy*; D012720:Severity of Illness Index; D012890:Sleep; D016896:Treatment Outcome
chemical_list: D018491:Dopamine Agonists; D007211:Indoles; D010919:Placebos; C046649:ropinirole