Sleep Medicine
Volume 7, Issue 5 , Pages 407-417 , August 2006

Efficacy and safety of pramipexole in idiopathic restless legs syndrome: A polysomnographic dose-finding study—The PRELUDE study

  • Markku Partinen

      Affiliations

    • Skogby Sleep Clinic, Rinnekoti Research Centre, Kumputie 3, FI-02980 Espoo, Finland
    • Department of Neurology, University of Helsinki, FI-00014 Helsinki, Finland
    • Corresponding Author InformationCorresponding author. Address: Skogby Sleep Clinic, Rinnekoti Research Centre, Kumputie 3, FI-02980 Espoo, Finland. Tel.:+358 9 8551345; fax: +358 9 8551375.
    • Dr Partinen has received a grant from the Rinnekoti Research Foundation for his studies on restless legs syndrome (RLS), and he has received honoraria, totaling less than USD10,000per year, for his presentations in postgraduate symposia on RLS.
    • ,
  • Kari Hirvonen

      Affiliations

    • Skogby Sleep Clinic, Rinnekoti Research Centre, Kumputie 3, FI-02980 Espoo, Finland
    • Neurotest Tampere Oy, Hatanpään Valtatie 1, FIN-33100 Tampere, Finland
    • The author has no conflict of interest related to this article.
    • ,
  • Leni Jama

      Affiliations

    • Skogby Sleep Clinic, Rinnekoti Research Centre, Kumputie 3, FI-02980 Espoo, Finland
    • The author has no conflict of interest related to this article.
    • ,
  • Anniina Alakuijala

      Affiliations

    • Skogby Sleep Clinic, Rinnekoti Research Centre, Kumputie 3, FI-02980 Espoo, Finland
    • Department of Clinical Neurophysiology, University Hospital of Helsinki, P.O. Box 340, FI-00029 Helsinki, Finland
    • The author has no conflict of interest related to this article.
    • ,
  • Christer Hublin

      Affiliations

    • Finnish Institute of Occupational Health, Brain at Work Research Center, Topeliuksenkatu 41 a A, FI-00250 Helsinki, Finland
    • Department of Neurology, University of Helsinki, FI-00014 Helsinki, Finland
    • The author has no conflict of interest related to this article.
    • ,
  • Ilkka Tamminen

      Affiliations

    • Medical Division, Boehringer Ingelheim Finland Ky, Tammasaarenkatu 5, FI-00180 Helsinki, Finland
    • The author has no conflict of interest related to this article.
    • ,
  • Juergen Koester

      Affiliations

    • Medical Division, Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim, Germany
    • The author has no conflict of interest related to this article.
    • ,
  • Juergen Reess

      Affiliations

    • Department of Clinical Research CNS, Boehringer Ingelheim Pharma GmbH and Co. KG, Birkendorferstr.65, 88397 Biberach, Germany
    • The author has no conflict of interest related to this article.

Received 22 November 2005 ,Revised 16 February 2006 ,Accepted 6 March 2006.

References 

  1. Phillips B, Young T, Finn L, et al. Epidemiology of restless legs symptoms in adults. Arch Intern Med. 2000;160:2137–2141
  2. Rothdach AJ, Trenkwalder C, Haberstock J, et al. Prevalence and risk factors of RLS in an elderly population: the MEMO study. Memory and morbidity in augsburg elderly. Neurology. 2000;54:1064–1068
  3. Hening W, Walters AS, Allen RP, et al. Impact, diagnosis and treatment of restless legs syndrome (RLS) in a primary care population: the REST (RLS epidemiology, symptoms, and treatment) primary care study. Sleep Med. 2004;5:237–246
  4. Lavigne GJ, Montplaisir JY. Restless legs syndrome and sleep bruxism: prevalence and association among Canadians. Sleep. 1994;17:739–743
  5. Berger K, Luedemann J, Trenkwalder C, et al. Sex and the risk of restless legs syndrome in the general population. Arch Intern Med. 2004;164:196–202
  6. Earley CJ, Allen RP, Beard JL, Connor JR. Insight into the pathophysiology of restless legs syndrome. J Neurosci Res. 2000;62:623–628
  7. Earley CJ. Clinical practice. Restless legs syndrome. N Engl J Med. 2003;348:2103–2109
  8. Sonka K, Kemlink D. Restless legs syndrome in 2004. Prague Med Rep. 2004;105:337–356
  9. Allen RP, Picchietti D, Hening WA, 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 institutes of health. Sleep Med. 2003;4:101–119
  10. Allen RP, Earley CJ. Restless legs syndrome: a review of clinical and pathophysiologic features. J Clin Neurophysiol. 2001;18:128–147
  11. Stiasny-Kolster K, Benes H, Peglau I, Hornyak M, et al. Effective cabergoline treatment in idiopathic restless legs syndrome. Neurology. 2004;63:2272–2279
  12. Allen R, Becker PM, Bogan R, et al. Ropinirole decreases periodic leg movements and improves sleep parameters in patients with restless leg syndrome. Sleep. 2004;27:907–914
  13. Silber MH, Ehrenberg BL, Allen RP, et al. An algorithm for the management of restless legs syndrome. Mayo Clin Proc. 2004;79:916–922
  14. Michaud M, Dumont M, Selmaoui B, et al. Circadian rhythm of restless legs syndrome: relationship with biological markers. Ann Neurol. 2004;55:372–380
  15. Chesson AL, Wise M, Davila D, et al. Practice parameters for the treatment of restless legs syndrome and periodic limb movement disorder. An American academy of sleep medicine report. Standards of practice committee of the American academy of sleep medicine. Sleep. 1999;22:961–968
  16. Deleu D, Northway MG, Hanssens Y. Clinical pharmacokinetic and pharmacodynamic properties of drugs used in the treatment of Parkinson's disease. Clin Pharmacokinet. 2002;41:261–309
  17. Montplaisir J, Nicolas A, Denesle R, Gomez-Mancilla B. Restless legs syndrome improved by pramipexole: a double-blind randomized trial. Neurology. 1999;52:938–943
  18. 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
  19. Lin SC, Kaplan J, Burger CD, Fredrickson PA. Effect of pramipexole in treatment of resistant restless legs syndrome. Mayo Clin Proc. 1998;73:497–500
  20. Lin S, Kaplan J, Burger C, Fredrickson P. Long-term use of pramipexole in the treatment of restless legs syndrome: a two-year follow-up. The sixth international congress of Parkinson's disease and movement disorders, Barcelona, Spain, 11–15 June, 2000.
  21. Becker PM, Ondo W, Sharon D. Encouraging initial response of restless legs syndrome to pramipexole. Neurology. 1998;51:1221–1223
  22. Stiasny-Kolster K, Oertel WH. Low-dose pramipexole in the management of restless legs syndrome. Neuropsychobiology. 2004;50:65–70
  23. Walters AS, LeBrocq C, Dhar A, et al. For the international restless legs syndrome study group. Validation of the international restless legs syndrome study group rating scale for restless legs syndrome. Sleep Med. 2003;4:121–132
  24. Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991;14:540–545
  25. Jenkinson C, Coulter A, Wright L. Short form 36 (SF36) health survey questionnaire: normative data for adults of working age. Br Med J. 1993;306:1437–1440
  26. National Institute of Mental Health (NIMH). Early clinical drug evaluation unit (ECDEU). Clinical global impressions. In:  Guy W editors. ECDEU assessment manual for psychopharmacology. rev. Rockville, MD: NIMH USA; 1976;
  27. Solovieva S, Santavirta N, Santavirta S, Konttinen YT. Assessing quality of life in individuals with hereditary blood coagulation disorders. Qual Life Res. 2004;13:987–1000
  28. Trenkwalder C, Hundemer HP, Lledo A, et al. Efficacy of pergolide in treatment of restless legs syndrome: the PEARLS study. Neurology. 2004;62:1391–1397
  29. Benes 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;27:674–682
  30. Adler CH, Hauser RA, Sethi K, et al. Ropinirole for restless legs syndrome. Neurology. 2004;62:1405–1407
  31. Abetz L, Allen R, Follet A, et al. Evaluating the quality of life of patients with restless legs syndrome. Clin Ther. 2004;26:925–935
  32. Allen RP, Walters AS, Montplaisir J, et al. Restless legs syndrome prevalence and impact: REST general population study. Arch Intern Med. 2005;165:1286–1292

☆ PRELUDE, Pramipexole for RLS: efficacy and tolerability of the usage of dopamine agonists.

PII: S1389-9457(06)00100-6

doi: 10.1016/j.sleep.2006.03.011

Sleep Medicine
Volume 7, Issue 5 , Pages 407-417 , August 2006

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