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

Sleep Medicine

Volumn 9, Issue 8, 2008, Pages 865-873

  Oertel, Wolfgang H ^a   Benes, Heike ^b   Garcia Borreguero, Diego ^c   Geisler, Peter ^d   Högl, Birgit ^e   Trenkwalder, Claudia ^f   Tacken, Ingrid ^g   Schollmayer, Erwin ^g   Kohnen, Ralf ^h   Stiasny Kolster, Karin ^a  

^a PHILIPPS UNIVERSITY MARBURG   (Germany)

^b UNIVERSITY OF ROSTOCK   (Germany)

^c Sleep Disorders Center   (Spain)

^d UNIVERSITY OF REGENSBURG   (Germany)

^e INNSBRUCK MEDICAL UNIVERSITY   (Austria)

^f UNIVERSITY OF GÖTTINGEN   (Germany)

^g Schwarz Pharma AG   (Germany)

^h UNIVERSITY OF ERLANGEN NUREMBERG   (Germany)

Author keywords

Dopamine agonist; Long term therapy; Open label design; Restless legs syndrome; Rotigotine; Therapy; Transdermal patch

Indexed keywords

PLACEBO; ROTIGOTINE;

ADULT; APPLICATION SITE ERYTHEMA; APPLICATION SITE PRURITUS; APPLICATION SITE REACTION; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HALLUCINATION; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; OPEN STUDY; OUTCOME ASSESSMENT; PATIENT SATISFACTION; PRIORITY JOURNAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; RESTLESS LEGS SYNDROME; SKIN ALLERGY; SLEEP DISORDER; SYNCOPE;

ADMINISTRATION, CUTANEOUS; ADULT; AGED; DOPAMINE AGONISTS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; QUESTIONNAIRES; RESTLESS LEGS SYNDROME; SEVERITY OF ILLNESS INDEX; TETRAHYDRONAPHTHALENES; THIOPHENES; YOUNG ADULT;

EID: 55549144317     PISSN: 13899457     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.sleep.2008.04.012     Document Type: Article

References (44)

1. Allen R., Picchietti D., Hening W., Trenkwalder C., Walters A.S., 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 4 (2003) 101-119
2. Trenkwalder C., Paulus W., and Walters A.S. The restless legs syndrome. Lancet Neurol 4 (2005) 465-475
3. Ondo W. Restless legs syndrome. Curr Neurol Neurosci Rep 5 4 (2005) 266-274
4. Allen R.P., Walters A.S., Montplaisir J., Hening W., Myers A., Bell T.J., et al. Restless legs syndrome prevalence and impact: REST general population study. Arch Intern Med 165 11 (2005) 1286-1292
5. Trenkwalder C., Collado-Seidel V., Kazenwadel J., Wetter T., Oertel W.H., Selzer R., et al. One-year treatment with standard and sustained-release levodopa: appropriate long-term treatment of restless legs syndrome?. Mov Disord 18 10 (2003) 1184-1189
6. Allen R.P., and Earley C.J. Augmentation of the restless legs syndrome with carbidopa/levodopa. Sleep 19 3 (1996) 205-213
7. Beneš H., Heinrich C.R., Ueberall M.A., and 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 27 4 (2004) 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 63 12 (2004) 2272-2279
9. Zucconi M., Oldani A., Castronovo V., and Ferini-Strambi L. Cabergoline is an effective single-drug treatment for restless legs syndrome: clinical and actigraphic evaluation. Sleep 26 7 (2003) 815-818
10. Stiasny K., Wetter T.C., Winkelmann J., Brandenburg U., Penzel T., Rubin M., et al. Long-term effects of pergolide in the treatment of restless legs syndrome. Neurology 56 10 (2001) 1399-1402
11. Trenkwalder C., Hundemer H.-P., Lledo A., Swieca J., Polo O., Wetter T.C., et al. Efficacy of pergolide in treatment of restless legs syndrome: the PEARLS-study. Neurology 62 8 (2004) 1391-1397
12. Silber M.H., Shepard Jr. J.W., and Wisbey J.A. Pergolide in the management of restless legs syndrome: an extended study. Sleep 20 10 (1997) 878-882
13. Winkelman J.W., and Bennet S. Augmentation and tolerance with long-term pramipexole treatment of restless legs syndrome. Sleep Med 5 (2004) 9-14
14. Ferini-Strambi L., Oldani A., Castronovo V., and Zucconi M. RLS augmentation and pramipexole longterm treatment. Neurology 56 8 Suppl. 3 (2001) A20
15. Montplaisir J., Denesle R., and Petit D. Pramipexole in the treatment of restless legs syndrome: a follow-up study. Eur J Neurol 7 Suppl. 1 (2000) 27-31
16. Silber M.H., Girish M., and Izurieta R. Pramipexole in the management of restless legs syndrome: an extended study. Sleep 26 7 (2003) 819-821
17. Trenkwalder C., Stiasny-Kolster K., Kupsch A., Oertel W.H., 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 21 9 (2006) 1404-1410
18. Garcia-Borreguero D. Ropinirole is well tolerated and effective for the long-term treatment of restless legs syndrome. Neurology 64 Suppl. 1 (2005) A42
19. Montplaisir J., Karrasch J., Haan J., and Volc D. Ropinirole is effective in the long-term management of restless legs syndrome: a randomized controlled trial. Mov Disord 21 10 (2006) 1627-1635
20. Ondo W., Romanyshyn J., Vuong K., and Lai D. Long-term treatment of restless legs syndrome with dopamine agonists. Arch Neurol 61 9 (2004) 1393-1397
21. Earley C.J., and Allen R.P. Pergolide and carbidopa/levodopa treatment of the restless legs syndrome and periodic leg movements in sleep in a consecutive series of patients. Sleep 19 10 (1996) 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 22 5 (2007) 696-703
23. Jenner P. A novel dopamine agonist for the transdermal treatment of Parkinson's disease. Neurology 65 2 Suppl. 1 (2005) S3-S5
24. LeWitt P.A., Nausieda P.A., Chang F.L., 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 66 Suppl. 2 (2006) A184 [Abstract S123.003]
25. Naidu Y., and Chaudhuri K.R. Transdermal rotigotine: a new non-ergot dopamine agonist for the treatment of Parkinson's disease. Expert Opin Drug Deliv 4 (2007) 111-118
26. Watts R.L., Jankovic J., Watres C., Rajput A., Boroojerdi B., and Rao J. Randomized, blind, controlled trial of transdermal rotigotine in early Parkinson disease. Neurology 68 4 (2007) 272-276
27. Jankovic J., Watts R.L., Martin W., and Boroojerdi B. Transdermal rotigotine: double-blind, placebo-controlled trial in Parkinson's disease. Arch Neurol 64 5 (2007) 676-682
28. Stiasny-Kolster K., Kohnen R., Schollmayer E., Möller J.C., Oertel W.H., and 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 19 12 (2004) 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 W.H., Stiasny-Kolster K., Benes H., and Trenkwalder C. Severity rating of restless legs syndrome: validation of the RLS-6 scales. Sleep 27 Suppl. 1 (2004) 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 C.R., and Kurella B. Development of the disease-specific restless legs syndrome quality of life (RLS-QoL) questionnaire. Mov Disord 17 Suppl. 5 (2002) P743
34. Johns M.W. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 14 6 (1991) 540-545
35. Meindorfer C., Körner Y., Möller C., Stiasny-Kolster K., Oertel W.H., and Krüger H.-P. Driving in Parkinson's disease: mobility, accidents, and sudden onset of sleep at the wheel. Mov Disord 20 7 (2005) 832-842
36. Möller C., Körner Y., Cassel W., Meindorfer C., Krüger H.-P., Oertel W.H., et al. Sudden onset of sleep and dopaminergic therapy in patients with restless legs syndrome. Sleep Med 7 (2006) 333-339
37. Priano L., Gasco M.R., and Mauro A. Transdermal treatment options for neurological disorders. Drug Aging 23 (2006) 357-375
38. Burkman R.T. The transdermal contraceptive patch: a new approach to hormonal contraception. Int J Fertil Womens Med 47 2 (2002) 69-76
39. Furlan A.D., Sandoval J.A., Mailis-Gagnon A., and Tunks E. Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects. CMAJ 174 (2006) 1589-1594
40. Bhattoa H.P., Bettembuk P., Balogh A., Szegedi G., and 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 15 (2004) 396-404
41. Trenkwalder C., Garcia-Borreguero D., Montagna P., Lainey E., de Weerd A.W., 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 75 1 (2004) 92-97
42. Walters A.S., Ondo W., Dreykluft T., Grunstein R., Lee D., and 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 19 12 (2004) 1414-1423
43. Homann C.N., Wenzel K., Suppan K., Ivanic G., Kriechbaum N., Crevenna R., et al. Sleep attacks in patients taking dopamine agonists: review. BMJ 324 7352 (2002) 1483-1487
44. Bassetti C.L., Clavadetscher S.C., Gugger M., and Hess C.W. Pergolide-associated 'sleep attacks' in a patient with restless legs syndrome. Sleep Med 3 (2002) 275-277