Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome: A randomized, placebo-controlled polysomnographic study

Wolfgang H. Oertel, Heike Beneš, Diego Garcia-Borreguero, Birgit Högl, Werner Poewe, Pasquale Montagna, Luigi Ferini-Strambi, Friederike Sixel-Döring, Claudia Trenkwalder, Markku Partinen, Bernd Saletu, Olli Polo, Andreas Fichtner, Erwin Schollmayer, Ralf Kohnen, Werner Cassel, Thomas Penzel, Karin Stiasny-Kolster

Research output: Contribution to journalArticlepeer-review

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 3 mg/24 h) 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

Original languageEnglish
Pages (from-to)848-856
Number of pages9
JournalSleep Medicine
Volume11
Issue number9
DOIs
Publication statusPublished - Oct 2010

Keywords

  • Dopamine agonist
  • Idiopathic restless legs syndrome
  • Periodic limb movement
  • Polysomnography
  • Rotigotine
  • Sleep
  • Transdermal patch

ASJC Scopus subject areas

  • Medicine(all)

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