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 language | English |
|---|---|
| Pages (from-to) | 595-604 |
| Number of pages | 10 |
| Journal | The Lancet Neurology |
| Volume | 7 |
| Issue number | 7 |
| DOIs | |
| Publication status | Published - Jul 2008 |
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ASJC Scopus subject areas
- Clinical Neurology
Cite this
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 journal › Article
}
TY - JOUR
T1 - Efficacy of rotigotine for treatment of moderate-to-severe restless legs syndrome
T2 - a randomised, double-blind, placebo-controlled trial
AU - Trenkwalder, Claudia
AU - Beneš, Heike
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
AU - Kohnen, Ralf
PY - 2008/7
Y1 - 2008/7
N2 - 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
AB - 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
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U2 - 10.1016/S1474-4422(08)70112-1
DO - 10.1016/S1474-4422(08)70112-1
M3 - Article
VL - 7
SP - 595
EP - 604
JO - The Lancet Neurology
JF - The Lancet Neurology
SN - 1474-4422
IS - 7
ER -