Rotigotine improves restless legs syndrome: A 6-month randomized, double-blind, placebo-controlled trial in the United States

Wayne A. Hening, Richard P. Allen, William G. Ondo, Arthur S. Walters, John W. Winkelman, Philip Becker, Richard Bogan, June M. Fry, David B. Kudrow, Kurt W. Lesh, Andreas Fichtner, Erwin Schollmayer

Research output: Contribution to journalArticle

91 Scopus citations

Abstract

This randomized, double-blinded, placebo-controlled trial (NCT00135993) assessed efficacy and safety of the dopamine agonist rotigotine in the treatment of idiopathic restless legs syndrome (RLS) over a 6-month maintenance period. A total of 505 eligible participants with moderate to severe RLS (IRLS sum score ≥ 15) were randomly assigned to five groups to receive either placebo or rotigotine (0.5, 1, 2, or 3 mg/24 hr) delivered by once-daily transdermal patch (fixed-dose regimen). The two co-primary efficacy parameters decreased from baseline to end of maintenance in IRLS sum score and in clinical global impressions (CGI-1) score. On both primary measures, 2 and 3 mg/24 hr rotigotine was superior to placebo (P < 0.001). Adjusted treatment differences to placebo for the IRLS sum score were -4.5 (95% CI: -6.9, -2.2) for 2 mg/24 hr rotigotine, -5.2 (95% CI: -7.5, -2.9) for 3 mg/24 hr rotigotine, and for CGI item 1 -0.65 (95% CI: -1.0, -0.3) and -0.9 (95% CI: -1.3, -0.5) for the 2 and 3 mg/24 hr doses, respectively. Skin reactions (27%) and known dopaminergic side effects such as nausea (18.1%) and headache (11.6%) were mostly mild or moderate in rotigotine subjects. Rotigotine transdermal patches releasing 2 to 3 mg/24 hr significantly reduced the severity of RLS symptoms. Treatment efficacy was maintained throughout the 6-month double-blind period.

Original languageEnglish (US)
Pages (from-to)1675-1683
Number of pages9
JournalMovement Disorders
Volume25
Issue number11
DOIs
StatePublished - Aug 15 2010

Keywords

  • Daytime/night-time symptoms
  • Dopamine agonist
  • Quality of life
  • Restless legs syndrome
  • Rotigotine transdermal patch

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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