Efficacy of rotigotine for treatment of moderate-to-severe restless legs syndrome

a randomised, double-blind, placebo-controlled trial

Claudia Trenkwalder, Heike Beneš, Werner Poewe, Wolfgang H. Oertel, Diego Garcia-Borreguero, Al W. de Weerd, Luigi Ferini-Strambi, Pasquale Montagna, Per Odin, Karin Stiasny-Kolster, Birgit Högl, K. Ray Chaudhuri, Markku Partinen, Erwin Schollmayer, Ralf Kohnen

Research output: Contribution to journalArticle

171 Citations (Scopus)

Abstract

Background: Continuous administration of a dopamine agonist could be used to treat patients with restless legs syndrome. Our aim was to investigate the efficacy of transdermal rotigotine in the treatment of idiopathic restless legs syndrome. Methods: In this randomised, double-blind, placebo-controlled trial, 458 patients with moderate-to-severe idiopathic restless legs syndrome (average baseline International Restless Legs Syndrome Study Group severity rating scale [IRLS] sum score of 28·1) were randomly assigned to receive transdermal rotigotine 1 mg over 24 h (n=115), 2 mg over 24 h (n=112), or 3 mg over 24 h (n=114), or to receive placebo (n=117). Study medication was delivered via patches, applied once a day for 6 months. Randomisation was done with a computer-generated randomisation list, stratified by centre. Primary efficacy outcomes were absolute change from baseline to end of maintenance in IRLS sum score and in the clinical global impressions (CGI) item 1 score, assessed by analysis of covariance in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT00136045. Findings: Efficacy analyses were done on 112 patients in the 1 mg group, 109 in the 2 mg group, 112 in the 3 mg group, and 114 in the placebo group. Mean change in IRLS sum score from baseline at the end of the maintenance phase was -13·7 (SE 0·9) in the 1 mg group, -16·2 (0·9) in the 2 mg group, -16·8 (0·9) in the 3 mg group, and -8·6 (0·9) in the placebo group (p

Original languageEnglish
Pages (from-to)595-604
Number of pages10
JournalThe Lancet Neurology
Volume7
Issue number7
DOIs
Publication statusPublished - Jul 2008

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Restless Legs Syndrome
Placebos
Random Allocation
Maintenance
Dopamine Agonists
N 0437
Population
Therapeutics

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Trenkwalder, C., Beneš, H., Poewe, W., Oertel, W. H., Garcia-Borreguero, D., de Weerd, A. W., ... Kohnen, R. (2008). Efficacy of rotigotine for treatment of moderate-to-severe restless legs syndrome: a randomised, double-blind, placebo-controlled trial. The Lancet Neurology, 7(7), 595-604. https://doi.org/10.1016/S1474-4422(08)70112-1

Efficacy of rotigotine for treatment of moderate-to-severe restless legs syndrome : a randomised, double-blind, placebo-controlled trial. / Trenkwalder, Claudia; Beneš, Heike; Poewe, Werner; Oertel, Wolfgang H.; Garcia-Borreguero, Diego; de Weerd, Al W.; Ferini-Strambi, Luigi; Montagna, Pasquale; Odin, Per; Stiasny-Kolster, Karin; Högl, Birgit; Chaudhuri, K. Ray; Partinen, Markku; Schollmayer, Erwin; Kohnen, Ralf.

In: The Lancet Neurology, Vol. 7, No. 7, 07.2008, p. 595-604.

Research output: Contribution to journalArticle

Trenkwalder, C, Beneš, H, Poewe, W, Oertel, WH, Garcia-Borreguero, D, de Weerd, AW, Ferini-Strambi, L, Montagna, P, Odin, P, Stiasny-Kolster, K, Högl, B, Chaudhuri, KR, Partinen, M, Schollmayer, E & Kohnen, R 2008, 'Efficacy of rotigotine for treatment of moderate-to-severe restless legs syndrome: a randomised, double-blind, placebo-controlled trial', The Lancet Neurology, vol. 7, no. 7, pp. 595-604. https://doi.org/10.1016/S1474-4422(08)70112-1
Trenkwalder, Claudia ; Beneš, Heike ; Poewe, Werner ; Oertel, Wolfgang H. ; Garcia-Borreguero, Diego ; de Weerd, Al W. ; Ferini-Strambi, Luigi ; Montagna, Pasquale ; Odin, Per ; Stiasny-Kolster, Karin ; Högl, Birgit ; Chaudhuri, K. Ray ; Partinen, Markku ; Schollmayer, Erwin ; Kohnen, Ralf. / Efficacy of rotigotine for treatment of moderate-to-severe restless legs syndrome : a randomised, double-blind, placebo-controlled trial. In: The Lancet Neurology. 2008 ; Vol. 7, No. 7. pp. 595-604.
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AU - Poewe, Werner

AU - Oertel, Wolfgang H.

AU - Garcia-Borreguero, Diego

AU - de Weerd, Al W.

AU - Ferini-Strambi, Luigi

AU - Montagna, Pasquale

AU - Odin, Per

AU - Stiasny-Kolster, Karin

AU - Högl, Birgit

AU - Chaudhuri, K. Ray

AU - Partinen, Markku

AU - Schollmayer, Erwin

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