Multi-national, multi-center, randomised, double-blind, active controlled trial to compare efficacy and tolerability of cabergoline and levodopa in patients with severe restless l…

Introduction: Dopaminergic drugs are considered as the main therapeutic option for patients with a Restless Legs Syndrome (RLS). However, no clinical trial with sufficient statistical power has been conducted up to now which compared efficacy and tolerability of two active dopaminergic treatments. We report here the results on the secondary outcome measures of the first large-scale double-blind, randomized study to compare the dopamine agonist cabergoline (CAB) and levodopa/benserazide (LEV). Methods: Patients with idiopathic RLS were treated with fixed daily doses of 2mg CAB or 200mg LEV; in the event of insuff…