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From the Department of Neurology (Drs. Stiasny-Kolster and Oertel), Philipps-University, Marburg; Medical Center (Dr. Benes), Clinic of Neurology, Schwerin; Private Practice of Neurology and Psychiatry (Dr. Peglau), Berlin; Department of Psychiatry and Psychotherapy (Dr. Hornyak), University Hospital, Freiburg; Department of Neurology (Dr. Holinka), Knappschaft Hospital, Bochum; Department of Neurology (Dr. Wessel), Municipal Hospital, and Cognitive Neurology, Institute at the Technical University, Braunschweig; Department of Neurology (Dr. Emser), Caritas Hospital, Dillingen; Pharmacia GmbH (Dr. Leroux), Erlangen; and IMEREM Institute for Medical Research Management and Biometrics (Dr. Kohnen), Nuremberg, Germany.
Address correspondence and reprint requests to Dr. Karin Stiasny-Kolster, Department of Neurology, Center of Nervous Diseases, Rudolf-Bultmann-Strasse 8, D-35033 Marburg, Germany; e-mail: stiasny{at}staff.uni-marburg.de
Objective: To assess the efficacy and safety of the dopamine agonist cabergoline (CAB) in patients with restless legs syndrome (RLS).
Methods: Patients with moderate to severe RLS were randomized into four groups receiving placebo, 0.5 mg, 1 mg, or 2 mg CAB once daily in a double-blind, placebo-controlled, multicenter dose-finding trial followed by an open long-term extension trial of 47 weeks. Efficacy was assessed with the RLS-6 scales and International RLS Study Group severity scale (IRLS).
Results: A total of 85 patients (age 56 ± 10 years, 71% females) were treated. Severity of RLS-6 scale symptoms during the night (the primary endpoint) was markedly improved by all CAB doses compared to placebo (placebo: –1.4 ± 3.1, 0.5 mg CAB: –4.2 ± 3.0 [p = 0.0082], 1.0 mg CAB: –4.0 ± 2.9 [p = 0.0040], 2.0 mg CAB: –4.8 ± 3.7 [p = 0.0026]). Similar results were found for the RLS severity at bedtime and during the day, IRLS, and satisfaction with sleep. A stable, clinically relevant improvement was achieved in all efficacy measures (severity during the night: change between last assessment and baseline: –5.6 ± 2.5, rate of remission: 71.2%) throughout 1 year with a mean CAB dose of 2.2 mg per day. During long-term treatment, 6 of 66 treated patients were affected (n = 2) or possibly affected (n = 4) by mild augmentation. Under CAB therapy up to 1 year, 11 of 85 patients discontinued treatment due to a drug-related adverse event.
Conclusions: Cabergoline is an efficacious and well-tolerated option for the treatment of restless legs symptoms during the night and the day.
Received January 21, 2004. Accepted in final form September 2, 2004.
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 December 28 issue to find the title link for this article.
See also page 2213
Related Articles
Neurology 2004 63: 2202-2003.
Neurology 2004 63: 2213-2214.
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