Sleep Medicine
Volume 9, Issue 8 , Pages 874-881 , December 2008

Effect of pramipexole on RLS symptoms and sleep: A randomized, double-blind, placebo-controlled trial

  • Luigi Ferini-Strambi

      Affiliations

    • Institute San Raffaele Turro, Via Stamira D’Ancona, 20, Milan 20127, Italy
    • ,
  • Dagfinn Aarskog

      Affiliations

    • Colosseumklinikken, Soerkedalsveien 10c, Oslo N-0369, Norway
    • ,
  • Markku Partinen

      Affiliations

    • Skogby Sleep Clinic, Rinnekoti Research Center, Kumputie 1, Espoo FI 02980, Finland
    • ,
  • K. Ray Chaudhuri

      Affiliations

    • National Parkinson Foundation Centre of Excellence and National RLS Clinic, King’s College Hospital, 9th Floor Ruskin Wing, Denmark Hill, London SE5 9RS, United Kingdom
    • ,
  • Mandy Sohr

      Affiliations

    • Boehringer Ingelheim GmbH, Binger Str. 173, Ingelheim 55216, Germany
    • ,
  • Daniela Verri

      Affiliations

    • Medical Department, Boehringer Ingelheim Italia S.p.A., Via Lorenzini 8, Milan 20139, Italy
    • ,
  • Stefan Albrecht

      Affiliations

    • Boehringer Ingelheim GmbH, Binger Str. 173, Ingelheim 55216, Germany
    • Corresponding Author InformationCorresponding author.

Received 2 May 2008 ,Revised 28 August 2008 ,Accepted 11 September 2008.

References 

  1. Allen RP, Picchietti D, Hening WA, Trenkwalder C, Walters AS, Montplaisir J. 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
  2. Hening W, Walters AS, Allen RP, Montplaisir J, Myers A, Ferini-Strambi L. 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
  3. Banno K, Delaive K, Walld R, Kryger MH. Restless legs syndrome in 218 patients: associated disorders. Sleep Med. 2000;1:221–229
  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;165:1286–1292
  5. Abetz L, Arbuckle R, Allen RP, Garcia-Borreguero D, Hening W, Walters AS. The reliability, validity and responsiveness of the international restless legs syndrome study group rating scale and subscales in a clinical-trial setting. Sleep Med. 2006;7:340–349
  6. Pearson VE, Allen RP, Dean T, Gamaldo CE, Lesage SR, Earley CJ. Cognitive deficits associated with restless legs syndrome (RLS). Sleep Med. 2006;7:25–30
  7. Oertel WH, Stiasny-Kolster K, Bergtholdt B, Hallström Y, Albo J, Leissner L. Efficacy of pramipexole in restless legs syndrome: a six-week, multicenter, randomized, double-blind study (effect-RLS study). Mov Disord. 2007;22:213–219
  8. Partinen M, Hirvonen K, Jama L, Alakuijala A, Hublin C, Tamminen I. Efficacy and safety of pramipexole in idiopathic restless legs syndrome: a polysomnographic dose-finding study: the PRELUDE study. Sleep Med. 2006;7:407–417
  9. Trenkwalder C, Stiasny-Kolster K, Kupsch A, Oertel WH, Koester J, Reess J. Controlled withdrawal of pramipexole after 6 months of open-label treatment in patients with restless legs syndrome. Mov Disord. 2006;21:1404–1410
  10. Winkelman JW, Sethi KD, Kushida CA, Becker PM, Koester J, Cappola JJ, et al. Efficacy and safety of pramipexole in restless legs syndrome. Neurology. 2006;67:1034–1039
  11. Hays RD, Martin SA, Sesti AM, Spritzer KL. Psychometric properties of the medical outcomes study sleep measure. Sleep Med. 2005;6:41–44
  12. Katz DA, McHorney CA. The relationship between insomnia and health-related quality of life in patients with chronic illness. J Fam Pract. 2002;51:229–235
  13. Walters AS, Ondo WG, 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;19:1414–1423
  14. Walters AS, LeBrocq C, Dhar A, Hening W, Rosen R, Allen RP, et al. Validation of the international restless legs syndrome study group rating scale for restless legs syndrome. Sleep Med. 2003;4:121–132
  15. Abetz L, Vallow SM, Kirsch J, Allen RP, Washburn T, Earley CJ. Validation of the restless legs syndrome quality of life questionnaire. Value Health. 2005;8:157–167
  16. Trenkwalder C, Garcia-Borreguero D, Montagna P, Lainey E, de Weerd AW, Tidswell P. 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;75:92–97
  17. Phillips B. Movement disorders: a sleep specialist’s perspective. Neurology. 2004;62:S9–S16
  18. Cuellar NG, Strumpf NE, Ratcliffe SJ. Symptoms of restless legs syndrome in older adults: outcomes on sleep quality, sleepiness, fatigue, depression, and quality of life. J Am Geriatr Soc. 2007;55:1387–1392
  19. Ferini-Strambi L. Restless legs syndrome augmentation and pramipexole treatment. Sleep Med. 2002;3(Suppl):S23–S25
  20. Winkelman JW, Johnston L. Augmentation and tolerance with long-term pramipexole treatment of restless legs syndrome (RLS). Sleep Med. 2004;5:9–14
  21. Silber MH, Girish M, Izurieta R. Pramipexole in the management of restless legs syndrome: an extended study. Sleep. 2003;26:819–821
  22. Ondo W, Romanyshyn J, Vuong KD, Lai D. Long-term treatment of restless legs syndrome with dopamine agonists. Arch Neurol. 2004;61:1393–1397
  23. Garcia-Borreguero D, Allen RP, Kohnen R, Högl B, Trenkwalder C, Oertel W. Diagnostic standards for dopaminergic augmentation of restless legs syndrome: report from a World association of sleep medicine-international restless legs syndrome study group consensus conference at the Max Planck Institute. Sleep Med. 2007;8:520–530
  24. Allen R, Becker PM, Bogan R, Schmidt M, Kushida CA, Fry JM. Ropinirole decreases periodic leg movements and improves sleep parameters in patients with restless leg syndrome. Sleep. 2004;27:907–914
  25. Trenkwalder C, Hundemer HP, Lledo A, Swieca J, Polo O, Wetter TC. Efficacy of pergolide in treatment of restless legs syndrome: the PEARLS Study. Neurology. 2004;62:1391–1397
  26. Manconi M, Ferri R, Zucconi M, Oldani A, Fantini ML, Castronovo V, et al. First night efficacy of pramipexole in restless legs syndrome and periodic leg movements. Sleep Med. 2007;8:491–497

PII: S1389-9457(08)00266-9

doi: 10.1016/j.sleep.2008.09.001

Sleep Medicine
Volume 9, Issue 8 , Pages 874-881 , December 2008

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