title: Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome: a randomized, placebo-controlled polysomnographic study.
abstract: OBJECTIVE
  To assess the efficacy of rotigotine transdermal patch in subjects with moderate to severe idiopathic restless legs syndrome (RLS) and periodic limb movement (PLM) in sleep in a double-blind, randomized, placebo-controlled, multicenter study (NCT00275236).
  
  
  METHODS
  Sixty-seven (46 rotigotine, 21 placebo) subjects applied rotigotine (maximum 3mg/24h) or placebo patches once-daily during a 4-week maintenance period; efficacy evaluations used polysomnographic measures and clinician/patient ratings.
  
  
  RESULTS
  Mean PLM index (PLMI; PLM/h time in bed) decreased more with rotigotine (50.9/h to 8.1/h) than with placebo (37.4/h to 27.1/h; adjusted treatment ratio 4.25 (95% CI [2.48,7.28], p<0.0001). PLM during sleep with arousal index (PLMSAI; 8.57/h to 2.47/h under rotigotine, 6.5/h to 4.95/h under placebo; adjusted treatment difference: -3.12 (95% CI [-5.36, -0.88], p=0.0072) also improved more under rotigotine. At end of maintenance, 39% of rotigotine subjects had PLMI levels <5/h and 26% showed no RLS symptoms (IRLS=0), whereas no placebo subject met these criteria. Common drug-related adverse events for rotigotine and placebo included nausea (21.7%/4.8%), headache (17.4%/14.3%), application site reactions (17.4%/4.8%), and somnolence (10.9%/9.5%); most were mild to moderate in intensity.
  
  
  CONCLUSIONS
  Rotigotine transdermal patch was efficacious and well tolerated in the short-term treatment of RLS motor symptoms and associated sleep disturbances.
authors.affiliation: Department of Neurology, Philipps Universität, Rudolf-Bultmann-Str. 8, Marburg, Germany.
authors.forename: Wolfgang H
authors.initials: WH
authors.lastname: Oertel
authors.forename: Heike
authors.initials: H
authors.lastname: Benes
authors.forename: Diego
authors.initials: D
authors.lastname: Garcia-Borreguero
authors.forename: Birgit
authors.initials: B
authors.lastname: Högl
authors.forename: Werner
authors.initials: W
authors.lastname: Poewe
authors.forename: Pasquale
authors.initials: P
authors.lastname: Montagna
authors.forename: Luigi
authors.initials: L
authors.lastname: Ferini-Strambi
authors.forename: Friederike
authors.initials: F
authors.lastname: Sixel-Döring
authors.forename: Claudia
authors.initials: C
authors.lastname: Trenkwalder
authors.forename: Markku
authors.initials: M
authors.lastname: Partinen
authors.forename: Bernd
authors.initials: B
authors.lastname: Saletu
authors.forename: Olli
authors.initials: O
authors.lastname: Polo
authors.forename: Andreas
authors.initials: A
authors.lastname: Fichtner
authors.forename: Erwin
authors.initials: E
authors.lastname: Schollmayer
authors.forename: Ralf
authors.initials: R
authors.lastname: Kohnen
authors.forename: Werner
authors.initials: W
authors.lastname: Cassel
authors.forename: Thomas
authors.initials: T
authors.lastname: Penzel
authors.forename: Karin
authors.initials: K
authors.lastname: Stiasny-Kolster
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009068:Movement / Q000187:drug effects; D017286:Polysomnography; D012148:Restless Legs Syndrome / Q000188:drug therapy*; D012720:Severity of Illness Index; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013876:Thiophenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D057968:Transdermal Patch; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine