Conditions: Restless Legs Syndrome Restless Legs Syndrome (RLS)
Keywords: PSG Restless Legs Syndrome gabapentin enacarbil XP13512 GSK1838262 sleep disturbance RLS polysomnography
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 136
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.

Detailed description:
Double-blind, multi-center, placebo-controlled, 2-period crossover study which assessed the efficacy and safety of gabapentin enacarbil (GEn; GSK1838262; XP13512) extended release tablets in adults with Restless Legs Syndrome (RLS)-associated sleep disturbance. One hundred thirty-six (136) adult subjects with RLS-associated sleep disturbance and periodic limb movements (PLM) were randomized from 23 centers in the United States. Subjects who met all eligibility criteria were randomized to receive a treatment sequence of GEn:placebo or placebo:GEn. Investigational product was taken with food at approximately 5pm. Investigational product was dosed as 600mg/day x3 days followed by 1200mg/day x25 days for each 4-week treatment period. There was a 1-week taper at 600mg after each treatment period followed by a 1-week washout between treatments. Polysomnography (PSG) was used to objectively evaluate changes in sleep and PLMs.

Arms:
arm 1: GSK1838262 extended release tablets for Treatment Period 1 followed by Placebo for Treatment Period 2 arm 2: Placebo for Treatment Period 1 followed by GSK1838262 for Treatment Period 2

Interventions: intervention 1: GSK1838262 Extended Release Tablets intervention 2: Placebo
Intervention descriptions: intervention 1: GSK1838262 extended release tablets intervention 2: Placebo

Protocol document: