Transdermal lisuride: short-term efficacy and tolerability study in patients with severe restless legs syndrome

Abstract

Background and purpose Restless legs syndrome (RLS) patients suffer from symptoms not only at bedtime but also with variable circadian patterns. Transdermal application forms of dopamine agonists are expected to lead to a stable plasma concentration of the active drug which could ease treatment for RLS patients with daytime symptoms and avoid side effects of oral dopaminergic therapies. Patients and methods In this controlled pilot study, 10 patients (six females, four males, mean age 58 years) with severe and long-lasting idiopathic RLS were treated during an initial open-label phase for 2 weeks either with one ( n=3 patients) or, if required, two patches of lisuride every other day (dose per patch: 3 mg lisuride, nominal effective release rate 7.0 μg lisuride/h). Patients were then randomized to double-blind treatment with lisuride ( n=5) or placebo ( n=4) for 1 week. Results Severity of RLS clearly improved during open-label and double-blind treatment with lisuride but became worse under placebo according to the International Restless Legs Syndrome Study Group Rating Scale (IRLS), RLS-6, and Clinical Global Impressions (CGIs) scales, and actigraphy assessments (periodic leg movement index) in the 1-week double-blind period. Conclusion The explorative findings of this small controlled study suggest that lisuride patches might be an efficacious treatment for RLS patients without clinically relevant tolerability problems.