TY - JOUR
T1 - Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome
T2 - A randomized, placebo-controlled polysomnographic study
AU - Oertel, Wolfgang H.
AU - Beneš, Heike
AU - Garcia-Borreguero, Diego
AU - Högl, Birgit
AU - Poewe, Werner
AU - Montagna, Pasquale
AU - Ferini-Strambi, Luigi
AU - Sixel-Döring, Friederike
AU - Trenkwalder, Claudia
AU - Partinen, Markku
AU - Saletu, Bernd
AU - Polo, Olli
AU - Fichtner, Andreas
AU - Schollmayer, Erwin
AU - Kohnen, Ralf
AU - Cassel, Werner
AU - Penzel, Thomas
AU - Stiasny-Kolster, Karin
PY - 2010/10
Y1 - 2010/10
N2 - 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
AB - 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
KW - Dopamine agonist
KW - Idiopathic restless legs syndrome
KW - Periodic limb movement
KW - Polysomnography
KW - Rotigotine
KW - Sleep
KW - Transdermal patch
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U2 - 10.1016/j.sleep.2010.02.014
DO - 10.1016/j.sleep.2010.02.014
M3 - Article
C2 - 20813583
AN - SCOPUS:79960342024
VL - 11
SP - 848
EP - 856
JO - Sleep Medicine
JF - Sleep Medicine
SN - 1389-9457
IS - 9
ER -