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Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance

Restless Legs Syndrome Clinical Trial

Official title:
Study RXP110908, a Polysomnography Study of GSK1838262 (XP13512) Extended Release Tablets Versus Placebo in the Treatment of Restless Legs Syndrome (RLS) and Associated Sleep Disturbance

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00748098
Study type Interventional
Source XenoPort, Inc.
Contact
Status Completed
Phase Phase 3
Start date October 2008
Completion date July 2009
View Details
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