Sleep Medicine
Volume 9, Issue 8 , Pages 865-873 , December 2008

One year open-label safety and efficacy trial with rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome

  • Wolfgang H. Oertel

      Affiliations

    • Department of Neurology, Philipps Universität, Marburg, Germany
  • ,
  • Heike Benes

      Affiliations

    • Somni bene Institute for Clinical Research and Sleep Medicine, Schwerin, and Department of Neurology, Universität Rostock, Germany
  • ,
  • Diego Garcia-Borreguero

      Affiliations

    • Sleep Disorders Center, Madrid, Spain
  • ,
  • Peter Geisler

      Affiliations

    • Department of Psychiatry, Universität Regensburg, Regensburg, Germany
  • ,
  • Birgit Högl

      Affiliations

    • Department of Neurology, Innsbruck Medical University, Innsbruck, Austria
  • ,
  • Claudia Trenkwalder

      Affiliations

    • Paracelsus-Elena Hospital, Kassel, and Department of Clinical Neurophysiology, Universität Goettingen, Germany
  • ,
  • Ingrid Tacken

      Affiliations

    • Schwarz Biosciences GmbH, UCB-Group, Monheim, Germany
  • ,
  • Erwin Schollmayer

      Affiliations

    • Schwarz Biosciences GmbH, UCB-Group, Monheim, Germany
  • ,
  • Ralf Kohnen

      Affiliations

    • IMEREM Institute for Medical Research Management and Biometrics and Department of Psychology, Universität Erlangen-Nuernberg, Nuernberg, Germany
  • ,
  • Karin Stiasny-Kolster

      Affiliations

    • Department of Neurology, Philipps Universität, Marburg, Germany
    • Corresponding Author InformationCorresponding author. Tel.: +49 6421 28 65475; fax: +49 6421 28 65307.
  • ,
  • on behalf of the Rotigotine SP710 Study Group

      Affiliations

    • Rotigotine SP710 Study Group: Austria: W. Poewe/B. Hoegl (Innsbruck), B. Saletu (Vienna), Germany: H. Benes (Schwerin), B. Bergtholdt (Berlin), R. Bodenschatz (Mittweida), P. Clarenbach (Bielefeld), I. Eisensehr (München), P. Franz (Berlin), P. Geisler (Regensburg), U. Hegerl (Nürnberg), W. Kaefferlein (Bamberg), M. Lang, (Ulm) G. Karlbauer (München), S. Kraemer (Berlin), I. Maier (Tuttlingen), G. Mayer (Schwalmstadt-Treysa), W. Oertel/K. Stiasny-Kolster/J.C. Möller (Marburg), C. Oehlwein (Gera), I. Peglau (Berlin), K. Sallach (Gelsenkirchen), K. Schlinsog (Halle), T. Schwerdtfeger (Naumburg), A. Schulze (Berlin), A. Siever (Oldenburg), K. Sigel (München), H. Sommer (Koethen), K. Tinschert (Jena), C. Trenkwalder (Kassel/Goettingen), B. Veit (Neubrandenburg), R. Warmuth (Berlin), Spain: E. Estevil (Barcelona), D. Garcia-Borreguero (Madrid), F. Puertas (Valencia).

Received 20 November 2007 ,Revised 28 March 2008 ,Accepted 3 April 2008.

References 

  1. Allen R, Picchietti D, Hening W, Trenkwalder C, Walters AS, Montplaisir J, et al. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institute of Health. Sleep Med. 2003;4:101–119
  2. Trenkwalder C, Paulus W, Walters AS. The restless legs syndrome. Lancet Neurol. 2005;4:465–475
  3. Ondo W. Restless legs syndrome. Curr Neurol Neurosci Rep. 2005;5(4):266–274
  4. Allen RP, Walters AS, Montplaisir J, Hening W, Myers A, Bell TJ, et al. Restless legs syndrome prevalence and impact: REST general population study. Arch Intern Med. 2005;165(11):1286–1292
  5. Trenkwalder C, Collado-Seidel V, Kazenwadel J, Wetter T, Oertel WH, Selzer R, et al. One-year treatment with standard and sustained-release levodopa: appropriate long-term treatment of restless legs syndrome?. Mov Disord. 2003;18(10):1184–1189
  6. Allen RP, Earley CJ. Augmentation of the restless legs syndrome with carbidopa/levodopa. Sleep. 1996;19(3):205–213
  7. Beneš H, Heinrich CR, Ueberall MA, Kohnen R. Long-term safety and efficacy of cabergoline for the treatment of idiopathic restless legs syndrome: results from an open-label 6-month clinical trial. Sleep. 2004;27(4):674–682
  8. Stiasny-Kolster K, Benes H, Peglau I, Hornyak M, Holinka B, Wessel K, et al. Effective cabergoline treatment in idiopathic restless legs syndrome (RLS). Neurology. 2004;63(12):2272–2279
  9. Zucconi M, Oldani A, Castronovo V, Ferini-Strambi L. Cabergoline is an effective single-drug treatment for restless legs syndrome: clinical and actigraphic evaluation. Sleep. 2003;26(7):815–818
  10. Stiasny K, Wetter TC, Winkelmann J, Brandenburg U, Penzel T, Rubin M, et al. Long-term effects of pergolide in the treatment of restless legs syndrome. Neurology. 2001;56(10):1399–1402
  11. Trenkwalder C, Hundemer H-P, Lledo A, Swieca J, Polo O, Wetter TC, et al. Efficacy of pergolide in treatment of restless legs syndrome: the PEARLS-study. Neurology. 2004;62(8):1391–1397
  12. Silber MH, Shepard JW, Wisbey JA. Pergolide in the management of restless legs syndrome: an extended study. Sleep. 1997;20(10):878–882
  13. Winkelman JW, Bennet S. Augmentation and tolerance with long-term pramipexole treatment of restless legs syndrome. Sleep Med. 2004;5:9–14
  14. Ferini-Strambi L, Oldani A, Castronovo V, Zucconi M. RLS augmentation and pramipexole longterm treatment. Neurology. 2001;56(8 Suppl. 3):A20
  15. Montplaisir J, Denesle R, Petit D. Pramipexole in the treatment of restless legs syndrome: a follow-up study. Eur J Neurol. 2000;7(Suppl. 1):27–31
  16. Silber MH, Girish M, Izurieta R. Pramipexole in the management of restless legs syndrome: an extended study. Sleep. 2003;26(7):819–821
  17. Trenkwalder C, Stiasny-Kolster K, Kupsch A, Oertel WH, Koester J, Reess J, et al. Controlled withdrawal of pramipexole after 6 months of open-label treatment in patients with restless legs syndrome. Mov Disord. 2006;21(9):1404–1410
  18. Garcia-Borreguero D. Ropinirole is well tolerated and effective for the long-term treatment of restless legs syndrome. Neurology. 2005;64(Suppl. 1):A42
  19. Montplaisir J, Karrasch J, Haan J, Volc D. Ropinirole is effective in the long-term management of restless legs syndrome: a randomized controlled trial. Mov Disord. 2006;21(10):1627–1635
  20. Ondo W, Romanyshyn J, Vuong K, Lai D. Long-term treatment of restless legs syndrome with dopamine agonists. Arch Neurol. 2004;61(9):1393–1397
  21. Earley CJ, Allen RP. Pergolide and carbidopa/levodopa treatment of the restless legs syndrome and periodic leg movements in sleep in a consecutive series of patients. Sleep. 1996;19(10):801–810
  22. Trenkwalder C, Benes H, Grote L, Happe S, Högl B, Mathis J, et al. Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome: results from a multi-center, randomized, active controlled trial. Mov Disord. 2007;22(5):696–703
  23. Jenner P. A novel dopamine agonist for the transdermal treatment of Parkinson’s disease. Neurology. 2005;65(2 Suppl. 1):S3–S5
  24. LeWitt PA, Nausieda PA, Chang FL, Fazzini E, Truong D, Carpenter M, et al. Rotigotine transdermal system in a multicenter trial of patients with advanced Parkinson’s disease as adjunctive therapy to levodopa. Neurology. 2006;66(Suppl. 2):A184;[Abstract S123.003]
  25. Naidu Y, Chaudhuri KR. Transdermal rotigotine: a new non-ergot dopamine agonist for the treatment of Parkinson’s disease. Expert Opin Drug Deliv. 2007;4:111–118
  26. Watts RL, Jankovic J, Watres C, Rajput A, Boroojerdi B, Rao J. Randomized, blind, controlled trial of transdermal rotigotine in early Parkinson disease. Neurology. 2007;68(4):272–276
  27. Jankovic J, Watts RL, Martin W, Boroojerdi B. Transdermal rotigotine: double-blind, placebo-controlled trial in Parkinson’s disease. Arch Neurol. 2007;64(5):676–682
  28. Stiasny-Kolster K, Kohnen R, Schollmayer E, Möller JC, Oertel WH the Rotigotine SP 666 Study Group. Patch-application of the dopamine agonist rotigotine to patients with moderate to advanced stages of restless legs syndrome – a double-blind placebo controlled pilot study. Mov Disord. 2004;19(12):1432–1438
  29. Oertel WH, Benes H, Garcia-Borreguero D, Geisler P, Högl B, Saletu B, et al. Efficacy of rotigotine transdermal system in severe restless legs syndrome: a randomized, double-blind, placebo-controlled, six-week dose-finding trial in Europe. Sleep Med 2007 [Epub ahead of print].
  30. The International Restless Legs Syndrome Study Group. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs. Sleep Med 2003;4:121–132.
  31. Kohnen R, Oertel WH, Stiasny-Kolster K, Benes H, Trenkwalder C. Severity rating of restless legs syndrome: validation of the RLS-6 scales. Sleep. 2004;27(Suppl. 1):A304;[Abstract 680]
  32. National Institute of Mental Health, editor. 028 CGI. Clinical Global Impressions. Rockville, MD: National Institute for Mental Health; 1976.
  33. Kohnen R, Benes H, Heinrich CR, Kurella B. Development of the disease-specific restless legs syndrome quality of life (RLS-QoL) questionnaire. Mov Disord. 2002;17(Suppl. 5):P743
  34. Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991;14(6):540–545
  35. Meindorfer C, Körner Y, Möller C, Stiasny-Kolster K, Oertel WH, Krüger H-P. Driving in Parkinson’s disease: mobility, accidents, and sudden onset of sleep at the wheel. Mov Disord. 2005;20(7):832–842
  36. Möller C, Körner Y, Cassel W, Meindorfer C, Krüger H-P, Oertel WH, et al. Sudden onset of sleep and dopaminergic therapy in patients with restless legs syndrome. Sleep Med. 2006;7:333–339
  37. Priano L, Gasco MR, Mauro A. Transdermal treatment options for neurological disorders. Drug Aging. 2006;23:357–375
  38. Burkman RT. The transdermal contraceptive patch: a new approach to hormonal contraception. Int J Fertil Womens Med. 2002;47(2):69–76
  39. Furlan AD, Sandoval JA, Mailis-Gagnon A, Tunks E. Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects. CMAJ. 2006;174:1589–1594
  40. Bhattoa HP, Bettembuk P, Balogh A, Szegedi G, Kiss E. The effect of 1-year transdermal estrogen replacement therapy on bone mineral density and biochemical markers of bone turnover in osteopenic postmenopausal systemic lupus erythematosus patients: a randomized, double-blind, placebo-controlled trial. Osteoporos Int. 2004;15:396–404
  41. Trenkwalder C, Garcia-Borreguero D, Montagna P, Lainey E, de Weerd AW, Tidswell P, et al. Ropinirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study, a 12 week, randomised, placebo controlled study in 10 European countries. J Neurol Neurosurg Psychiatry. 2004;75(1):92–97
  42. Walters AS, Ondo W, Dreykluft T, Grunstein R, Lee D, Sethi K. Ropinirole is effective in the treatment of restless legs syndrome: TREAT RLS 2: a 12-week double-blind, randomized, parallel-group, placebo-controlled study. Mov Disord. 2004;19(12):1414–1423
  43. Homann CN, Wenzel K, Suppan K, Ivanic G, Kriechbaum N, Crevenna R, et al. Sleep attacks in patients taking dopamine agonists: review. BMJ. 2002;324(7352):1483–1487
  44. Bassetti CL, Clavadetscher SC, Gugger M, Hess CW. Pergolide-associated ‘sleep attacks’ in a patient with restless legs syndrome. Sleep Med. 2002;3:275–277

PII: S1389-9457(08)00148-2

doi: 10.1016/j.sleep.2008.04.012

Sleep Medicine
Volume 9, Issue 8 , Pages 865-873 , December 2008