A randomized controlled study of pergolide in patients with restless legs syndrome

Background: Open clinical trials indicate that low doses of pergolide, a lo ng-acting D1 and D2 dopamine agonist, lead to a reduction in the symptoms o f restless legs syndrome (RLS) with subjective improvement in sleep quality . Objective: To assess the therapeutic efficacy of pergolide in improving s leep and subjective measures of well-being in patients with idiopathic RLS using polysomnography and clinical ratings. Methods: In a randomized, doubl e-blind, placebo-controlled crossover design we enrolled 30 patients with i diopathic RLS according to the criteria of the International RLS Study Grou p. All patients were free of psychoactive drugs for at least 2 weeks before the study. Patients were monitored using polysomnography, clinical ratings , and sleep diaries at baseline and at the end of a 4-week pergolide or pla cebo treatment period. The initial dosage of 0.05 mg pergolide was increase d to the best subjective improvement paralleled by 20 mg domperidone tid. R esults: At a mean dosage of 0.51 mg pergolide as a single daily dose 2 hour s before bedtime, there were fewer periodic leg movements per hour of time in bed (5.7 versus 54.9, p < 0.0001), and total sleep time was significantl y longer (373 versus 261 minutes, p < 0.0001). Ratings of subjective sleep quality, quality of life, and severity of RLS were improved significantly w ithout-relevant adverse events. Conclusion: Pergolide given as a single low -to-medium bedtime dose in combination with domperidone provides a well-tol erated and effective treatment of sensorimotor symptoms and sleep disturban ces in patients with primary RLS.