Progressive development of augmentation during long-term treatment with levodopa in restless legs syndrome: Results of a prospective multi-center study

Birgit Högl, Diego García-Borreguero, Ralf Kohnen, Luigi Ferini-Strambi, Georgios Hadjigeorgiou, Magdolna Hornyak, Al De Weerd, Svenja Happe, Karin Stiasny-Kolster, Viola Gschliesser, Renata Egatz, Birgit Frauscher, Heike Benes, Claudia Trenkwalder, Wayne A. Hening, Richard P. Allen

Research output: Contribution to journalArticle

Abstract

The European Restless Legs Syndrome (RLS) Study Group performed the first multi-center, long-term study systematically evaluating RLS augmentation under levodopa treatment. This prospective, open-label 6-month study was conducted in six European countries and included 65 patients (85% treatment naive) with idiopathic RLS. Levodopa was flexibly up-titrated to a maximum dose of 600 mg/day. Presence of augmentation was diagnosed independently by two international experts using established criteria. In addition to the augmentation severity rating scale (ASRS), changes in RLS severity (International RLS severity rating scale (IRLS), clinical global impression (CGI)) were analyzed. Sixty patients provided evaluable data, 35 completed the trial and 25 dropped out. Augmentation occurred in 60% (36/60) of patients, causing 11.7% (7/60) to drop out. Median time to occurrence of augmentation was 71 days. The mean maximum dose of levodopa was 311 mg/day (SD: 105). Patients with augmentation compared to those without were significantly more likely to be on higher doses of levodopa (≥300 mg, 83 vs. 54%, P = 0.03) and to show less improvement of symptom severity (IRLS, P = 0.039). Augmentation was common with levodopa, but could be tolerated by most patients during this 6-month trial. Patients should be followed over longer periods to determine if dropout rates increase with time.

Original languageEnglish
Pages (from-to)230-237
Number of pages8
JournalJournal of Neurology
Volume257
Issue number2
DOIs
Publication statusPublished - Feb 2010

Keywords

  • Augmentation
  • Clinical study
  • Diagnosis
  • Rating scale
  • Restless legs syndrome (RLS)

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

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    Högl, B., García-Borreguero, D., Kohnen, R., Ferini-Strambi, L., Hadjigeorgiou, G., Hornyak, M., De Weerd, A., Happe, S., Stiasny-Kolster, K., Gschliesser, V., Egatz, R., Frauscher, B., Benes, H., Trenkwalder, C., Hening, W. A., & Allen, R. P. (2010). Progressive development of augmentation during long-term treatment with levodopa in restless legs syndrome: Results of a prospective multi-center study. Journal of Neurology, 257(2), 230-237. https://doi.org/10.1007/s00415-009-5299-8