Randomized, double-blind, placebo-controlled trial of pergolide in restless legs syndrome

Objective: To assess the efficacy of pergolide in the treatment of restless legs syndrome (RLS). Methods: A randomized, double-blind, parallel-treatment evaluation of pergolide versus placebo in patients with RLS was performed. Sixteen patients seen in the Sleep Disorders Center who met the clinical criteria for RLS were enrolled in the study. Treatment was either placebo (n = 8) or pergolide (n = 8), which was on a self-adjusted schedule that ranged from 0.05 to 0.65 mg/day. Outcome variables included the patient's rating of symptom improvement, duration of RLS symptoms throughout the day, and objective sleep assessments from an all-night polysomnogram (percent sleep efficiency and periodic leg movements). Baseline was assessed for 2 days before starting treatment. Dose adjustments were made over the first 14 days and were then held constant for 5 days, with repeat assessment for treatment effects on the last 2 days of treatment (days 17 and 18). Results: As a group, pergolide recipients showed significant improvement clinically and statistically in all outcome measures when compared with baseline or with placebo treatment. On the other hand, placebo treatment led to no significant improvements in any outcome measures. Conclusions: Pergolide treatment significantly improved clinical symptoms and sleep efficiency, and reduced periodic Limb movements of sleep in patients with RLS.