Gabapentin enacarbil in Japanese patients with restless legs syndrome: a 12-week, randomized, double-blind, placebo-controlled, parallel-group study

AbstractObjectiveGabapentin enacarbil (GEn) was effective and well-tolerated for the treatment of restless legs syndrome (RLS) in North American studies. However, no placebo-controlled studies of GEn have been performed in Asian patients with RLS. Therefore, we investigated the efficacy and safety of GEn in Japanese patients with RLS to determine the optimal dosage.Research design and methodsOutpatients with RLS (International Restless Legs Syndrome Rating Scale (IRLS) scores ≥15) were randomized (n = 474) and treated (n = 469) in a double-blind manner with once-daily placebo (n = 116), 600 (n = 120), 900 (n = 119) or 1200 (n = 114) mg GEn for 12 weeks.Clinical trial registrationNCT00530530 (ClinicalTrials.gov)Main outcome measureThe primary outcome was the change in IRLS score. Secondary outcomes included Investigator (ICGI)- and Patient (PCGI)-rated Clinical Global Impression and adverse events.ResultsThe mean change in IRLS score from baseline to the final observation was −8.96 for placebo versus −11.1...