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

doi:10.1016/j.sleep.2010.02.014

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

IRCCS Ospedale San Raffaele

Research output: Contribution to journal › Article › peer-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 language	English
Pages (from-to)	848-856
Number of pages	9
Journal	Sleep Medicine
Volume	11
Issue number	9
DOIs	https://doi.org/10.1016/j.sleep.2010.02.014
Publication status	Published - 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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Oertel, W. H., Beneš, H., Garcia-Borreguero, D., Högl, B., Poewe, W., Montagna, P., Ferini-Strambi, L., Sixel-Döring, F., Trenkwalder, C., Partinen, M., Saletu, B., Polo, O., Fichtner, A., Schollmayer, E., Kohnen, R., Cassel, W., Penzel, T., & Stiasny-Kolster, K. (2010). Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome: A randomized, placebo-controlled polysomnographic study. Sleep Medicine, 11(9), 848-856. https://doi.org/10.1016/j.sleep.2010.02.014

Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome : A randomized, placebo-controlled polysomnographic study. / Oertel, Wolfgang H.; Beneš, Heike; Garcia-Borreguero, Diego; Högl, Birgit; Poewe, Werner; Montagna, Pasquale; Ferini-Strambi, Luigi; Sixel-Döring, Friederike; Trenkwalder, Claudia; Partinen, Markku; Saletu, Bernd; Polo, Olli; Fichtner, Andreas; Schollmayer, Erwin; Kohnen, Ralf; Cassel, Werner; Penzel, Thomas; Stiasny-Kolster, Karin.

In: Sleep Medicine, Vol. 11, No. 9, 10.2010, p. 848-856.

Research output: Contribution to journal › Article › peer-review

Oertel, WH, Beneš, H, Garcia-Borreguero, D, Högl, B, Poewe, W, Montagna, P, Ferini-Strambi, L, Sixel-Döring, F, Trenkwalder, C, Partinen, M, Saletu, B, Polo, O, Fichtner, A, Schollmayer, E, Kohnen, R, Cassel, W, Penzel, T & Stiasny-Kolster, K 2010, 'Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome: A randomized, placebo-controlled polysomnographic study', Sleep Medicine, vol. 11, no. 9, pp. 848-856. https://doi.org/10.1016/j.sleep.2010.02.014

Oertel, Wolfgang H. ; Beneš, Heike ; Garcia-Borreguero, Diego ; Högl, Birgit ; Poewe, Werner ; Montagna, Pasquale ; Ferini-Strambi, Luigi ; Sixel-Döring, Friederike ; Trenkwalder, Claudia ; Partinen, Markku ; Saletu, Bernd ; Polo, Olli ; Fichtner, Andreas ; Schollmayer, Erwin ; Kohnen, Ralf ; Cassel, Werner ; Penzel, Thomas ; Stiasny-Kolster, Karin. / Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome : A randomized, placebo-controlled polysomnographic study. In: Sleep Medicine. 2010 ; Vol. 11, No. 9. pp. 848-856.

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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 ",

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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

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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

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