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Abstract
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.
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