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This Article Figures Only Full Text Full Text (PDF) CME: Take the course for this article: Volume 67, Number 6, September 26, 2006 Data Supplement JapaneseTranslation All Versions of this Article: 01.wnl.0000237742.08297.22v1 67/6/1040    most recent Correspondence: Submit a response Alert me when this article is cited Alert me when Correspondence are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Oertel, W. H. Articles by Stiasny-Kolster, K. Search for Related Content PubMed PubMed Citation Articles by Oertel, W. H. Articles by Stiasny-Kolster, K. Related Collections All Clinical trials Clinical trials Randomized controlled (CONSORT agreement) Restless legs syndrome

Efficacy of cabergoline in restless legs syndrome

A placebo-controlled study with polysomnography (CATOR)

W. H. Oertel, MD, H. Bene, MD, R. Bodenschatz, MD, I. Peglau, MD, R. Warmuth, MD, S. Happe, MD, P. Geisler, MD, W. Cassel, MSc, M. Leroux, MD, R. Kohnen, PhD and K. Stiasny-Kolster, MD

From the Department of Neurology (W.H.O., R.K., K.S.-K.) and Department of Internal Medicine (W.C.), Sleep Laboratory central evaluation center, Philipps-University, Marburg, Germany; Somni bene Institute for Medical Research and Sleep Medicine Schwerin Ltd., Schwerin, Germany (H.B.); Private Practice of Neurology and Psychiatry, Mittweida (R.B.) and Berlin (I.P.), Germany; Private Practice for Sleep Medicine, Berlin, Germany (R.W.); Department of Clinical Neurophysiology, University Goettingen, Germany (S.H.); Department of Psychiatry and Psychotherapy, University of Regensburg, Germany (P.G.); Pfizer GmbH, Karlsruhe, Germany (M.L.); and IMEREM Institute for Medical Research Management and Biometrics, Nuremberg, Germany (R.K.).

Address correspondence and reprint requests to Dr. Wolfgang H. Oertel, Department of Neurology, Center of Nervous Diseases, Philipps-University Marburg, Rudolf-Bultmann-Str. 8, D-35033 Marburg, Germany; e-mail: oertelw{at}med.uni-marburg.de

Objective: To assess the efficacy and safety of the dopamine agonist cabergoline in the treatment of patients with idiopathic restless legs syndrome (CATOR study).

Methods: Patients with moderate to severe restless legs syndrome (RLS) were randomly assigned to cabergoline (single evening dose: 2 mg) or placebo and treated for 5 weeks in a double-blind, multicenter polysomnography (PSG) trial. The primary efficacy measures were the periodic leg movements during sleep arousal index (PLMS-AI) and sleep efficiency. These and further PSG variables were monitored by centrally evaluated PSG. Severity of RLS was assessed using the International RLS Study Group Severity Scale (IRLS), the RLS-6 scales, the Sleep Questionnaire Form A (SF-A; quality of sleep), and the Quality of Life for RLS questionnaire.

Results: Forty-three patients were treated and 40 patients were evaluated with PSG (age 56 ± 10 years, 73% women). Cabergoline was superior to placebo in terms of the PLMS-AI (–17.7 ± 16.4 vs –4.5 ± 20.0 placebo; p = 0.0024), sleep efficiency (+6.2 ± 13.9% vs +3.3 ± 11.7%; p = 0.0443), PLMS index (p = 0.0014), PLM index (p = 0.0012), and total sleep time (p = 0.0443). Improvements in IRLS total score (–23.7 ± 11.2 vs –7.9 ± 11.0 placebo; p = 0.0002), RLS-6 severity scales during the night (p = 0.0010) and during the day (p = 0.0018), Clinical Global Impressions severity item (p = 0.0003), sleep quality (p = 0.0180), SF-A sleep quality (p = 0.0371), and QoL-RLS (p = 0.0247) were larger in patients treated with cabergoline compared with the placebo group. Adverse events were only mild and well-known side effects of dopamine agonists.

Conclusion: Single-evening cabergoline is an efficacious and well-tolerated short-term therapy for sensorimotor symptoms of restless legs syndrome and associated sleep disturbances.

Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the September 26 issue to find the title link for this article.

This article was previously published in electronic format as an Expedited E-Pub on August 23, 2006, at www.neurology.org.

This research was supported by Pfizer GmbH, Karlsruhe, Germany, and by the Bundesministerium für Bildung und Forschung (BMBF, German Federal Ministry of Education and Research; 01GI9901/1).

Disclosure: The authors report no conflicts of interest.

Received June 2, 2005. Accepted in final form May 15, 2006.

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