Long-term maintenance treatment of restless legs syndrome with gabapentin enacarbil: a randomized controlled study.

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 po

SUBMITTER: Bogan RK 

PROVIDER: S-EPMC2878254 | biostudies-literature | 2010 Jun

REPOSITORIES: biostudies-literature