Abstract : OBJECTIVE To assess maintenance of efficacy and tolerability of gabapentin enacarbil in patients wi
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Abstract : OBJECTIVE To assess maintenance of efficacy and tolerability of gabapentin enacarbil in patients with moderate to severe primary restless legs syndrome (RLS).|PATIENTS AND METHODS This study (conducted April 18 2006 to November 14 2007) comprised a 24-week single-blind (SB) treatment phase (gabapentin enacarbil 1200 mg) followed by a 12-week randomized double-blind (DB) phase. Responders from the SB phase (patients with improvements on the International Restless Legs Scale IRLS and investigator-rated Clinical Global Impression-Improvement scale at week 24 and stable while taking a gabapentin enacarbil dose of 1200 mg for at least 1 month before randomization) were randomized to gabapentin enacarbil 1200 mg or placebo once daily at 5 pm with food. The primary end point was the proportion of patients experiencing relapse (worse scores on the IRLS and investigator-rated Clinical Global Impression of Change scale on 2 consecutive visits at least 1 week apart or withdrawal because of lack of efficacy) during the DB phase.|RESULTS A total of 221 of 327 patients completed the SB phase 194 (96 in the gabapentin enacarbil group and 98 in the placebo group) were randomized to DB treatment and 168 (84 in the gabapentin enacarbil group and 84 in the placebo group) completed the DB phase. A significantly smaller proportion of patients treated with gabapentin enacarbil (9/96 9) experienced relapse compared with the placebo-treated patients (22/97 23) (odds ratio 0.353 95 confidence interval 0.2-0.8 P=.02). Somnolence and dizziness were the most common adverse events. One death occurred (unintentional choking during the SB phase) and was judged as being unrelated to the study drug. No clinically relevant changes were observed in laboratory values in vital signs or on electrocardiograms.|CONCLUSION: Gabapentin enacarbil, 1200 mg, maintained improvements in RLS symptoms compared with placebo and showed long-term tolerability in adults with moderate to severe primary RLS for up to 9 months of treatment.|
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