Rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome: A randomized,placebo-controlled polysomnographic study |
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| Authors: | Wolfgang H Oertel Heike Bene? 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 |
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| Institution: | 1. Department of Neurology, Philipps Universität, Rudolf-Bultmann-Str. 8, D-35039 Marburg, Germany;2. Somni Bene Institute for Clinical Research and Sleep Medicine, 19053 Schwerin, Arsenalstr. 10, Germany;3. Department of Neurology, Universität Rostock, 18055 Rostock, Germany;4. Sleep Research Institute, Alberto Alcocer 19, 28036 Madrid, Spain;5. Department of Neurology, Innsbruck Medical University, Anichstr. 35, 6020 Innsbruck, Austria;6. Department of Neurological Sciences, University of Bologna, Via Ugo Foscolo 7, 40123 Bologna, Italy;7. Sleep Disorders Center, Vita-Salute San Raffaele University, Via Stamira d’ Ancona 20, 20127 Milan, Italy;8. Paracelsus-Elena Hospital, Klinikstr. 16, 34128 Kassel, Germany;9. Department of Clinical Neurophysiology, Georg-August Universität, Robert-Koch-Str. 40, 37079 Göttingen, Germany;10. Helsinki Sleep Clinic, Vitalmed Research Centre, Sitratori 3, 00420 Helsinki, Finland;11. Section of Sleep Research and Pharmacopsychiatry, Department of Psychiatry and Psychotherapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria;12. Sleep Research Unit, University of Turku, Lemminkaisenkatu 2, 20520 Turku, Finland and Tampere University Hospital, Tampere, Finland;13. Schwarz Biosciences GmbH, UCB Group, Alfred-Nobel-Str. 10, 40789 Monheim, Germany;14. RPS Research Germany, Scheurlstraße 21, 90478 Nürnberg, Germany;15. Department of Psychology, Universität Erlangen-Nürnberg, Nürnberg, Germany;p. Department of Internal Medicine, Sleep Disorders Center, Philipps Universität, Baldingerstr. 1, 35043 Marburg, Germany;q. Sleep Disorders Center, Charité University Hospital, Luisenstr. 3, 10117 Berlin, Germany |
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| Abstract: | ObjectiveTo 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).MethodsSixty-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.ResultsMean 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 <5/h and 26% showed no RLS symptoms (IRLS = 0), whereas no placebo subject met these criteria. Common drug-related adverse events for rotigotine and placebo included nausea (21.7%/4.8%), headache (17.4%/14.3%), application site reactions (17.4%/4.8%), and somnolence (10.9%/9.5%); most were mild to moderate in intensity.ConclusionsRotigotine transdermal patch was efficacious and well tolerated in the short-term treatment of RLS motor symptoms and associated sleep disturbances. |
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