Efficacy and Safety of Pregabalin for Restless Legs Syndrome in Korean Adults: A Randomized, Double-Blind, Placebo-Controlled Trial.

ABSTRACT:

Background and purpose

To evaluate the clinical efficacy and safety of pregabalin in Korean adults with restless legs syndrome (RLS).

Methods

In this randomized, multicenter, double-blind, placebo-controlled trial, 78 patients with RLS with an International Restless Legs Scale (IRLS) score ≥15 were randomized 1:1 to receive either pregabalin (n=39) or placebo (n=39) for 12 weeks. The primary efficacy outcome was the change in the IRLS score, and the secondary outcomes included the Clinical Global Impression-Improvement scale and changes in scores on other RLS symptom questionnaires. Safety was assessed by monitoring treatment-emergent adverse events (TEAE). This study was registered at ClinicalTrials.gov (NCT04161027).

Results

At baseline, the mean IRLS

SUBMITTER: Sunwoo JS 

PROVIDER: S-EPMC12303681 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature