Sleep medicine
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Randomized Controlled Trial Multicenter Study Comparative Study
A randomized, double-blind, 6-week, dose-ranging study of pregabalin in patients with restless legs syndrome.
This study evaluated the dose-related efficacy and safety of pregabalin in patients with idiopathic restless legs syndrome (RLS). ⋯ In this 6-week phase 2b study, pregabalin reduced RLS symptoms in patients with moderate-to-severe idiopathic RLS. The symptom reduction at week 6 was dose-dependent with 123.9 mg/day providing 90% efficacy. Pregabalin was safe and well tolerated across the entire dosing range.