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Status:

COMPLETED

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

Lead Sponsor:

XenoPort, Inc.

Conditions:

Restless Legs Syndrome

Restless Legs Syndrome (RLS)

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 wi...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Provided written informed consent.
  • Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
  • Have history of RLS symptoms at least 15 nights/month.
  • Minimum average of 15 Periodic Limb Movements during Sleep per hour (measured using actigraphy).
  • Exclusion criteria:
  • Secondary RLS
  • Primary sleep disorder
  • Sleep apnea
  • Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
  • Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
  • Use of any prohibited medication.

Exclusion

    Key Trial Info

    Start Date :

    October 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2009

    Estimated Enrollment :

    136 Patients enrolled

    Trial Details

    Trial ID

    NCT00748098

    Start Date

    October 1 2008

    End Date

    July 1 2009

    Last Update

    July 22 2013

    Active Locations (24)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (24 locations)

    1

    GSK Investigational Site

    Jasper, Alabama, United States, 35501

    2

    GSK Investigational Site

    San Diego, California, United States, 92103

    3

    GSK Investigational Site

    San Diego, California, United States, 92121

    4

    GSK Investigational Site

    Hallandale, Florida, United States, 33009