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Completed Phase 4 Interventional Results available

Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study

ClinicalTrials.gov ID: NCT01668667

Public ClinicalTrials.gov record NCT01668667. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 4:01 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group Study to Compare the Efficacy, Tolerability, and Safety of 3 Doses of Gabapentin Enacarbil (GSK1838262) With Placebo in Treatment of Moderate-to-Severe Primary RLS

Study identification

NCT ID
NCT01668667
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
XenoPort, Inc.
Industry
Enrollment
501 participants

Conditions and interventions

Interventions

  • GSK1838262 600 mg Drug
  • GSK1838262 450 mg Drug
  • GSK1838262 300 mg Drug
  • GSK1838262 Placebo match Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2012
Primary completion
Oct 31, 2013
Completion
Oct 31, 2013
Last update posted
May 23, 2021

2012 – 2013

United States locations

U.S. sites
42
U.S. states
24
U.S. cities
40
Facility City State ZIP Site status
GSK Investigational Site Phoenix Arizona 85020
GSK Investigational Site Phoenix Arizona 85050
GSK Investigational Site Tucson Arizona 85704
GSK Investigational Site Little Rock Arkansas 72211
GSK Investigational Site Santa Monica California 90404
GSK Investigational Site Colorado Springs Colorado 80907
GSK Investigational Site Denver Colorado 80239
GSK Investigational Site DeLand Florida 32720
GSK Investigational Site Tampa Florida 33609
GSK Investigational Site Atlanta Georgia 30342
GSK Investigational Site Woodstock Georgia 30189
GSK Investigational Site Lenexa Kansas 66214
GSK Investigational Site Topeka Kansas 66606
GSK Investigational Site Crestview Hills Kentucky 41017
GSK Investigational Site Louisville Kentucky 40217
GSK Investigational Site Metairie Louisiana 70006
GSK Investigational Site Chevy Chase Maryland 20815
GSK Investigational Site Bingham Farms Michigan 48025
GSK Investigational Site Omaha Nebraska 68134
GSK Investigational Site Las Vegas Nevada 89119
GSK Investigational Site Albuquerque New Mexico 87106
GSK Investigational Site Hickory North Carolina 28601
GSK Investigational Site Raleigh North Carolina 27612
GSK Investigational Site Winston-Salem North Carolina 27103
GSK Investigational Site Cincinnati Ohio 45255
GSK Investigational Site Cleveland Ohio 44130
GSK Investigational Site Middleburg Heights Ohio 44130
GSK Investigational Site Oklahoma City Oklahoma 73112
GSK Investigational Site Duncansville Pennsylvania 16635
GSK Investigational Site Lafayette Hill Pennsylvania 19444
GSK Investigational Site Warwick Rhode Island 02886
GSK Investigational Site Columbia South Carolina 29201
GSK Investigational Site Greer South Carolina 29651
GSK Investigational Site Mt. Pleasant South Carolina 29464
GSK Investigational Site Jackson Tennessee 38305
GSK Investigational Site Austin Texas 78731
GSK Investigational Site Fort Worth Texas 76135
GSK Investigational Site San Angelo Texas 76904
GSK Investigational Site San Antonio Texas 78205
GSK Investigational Site San Antonio Texas 78229
GSK Investigational Site Murray Utah 84123
GSK Investigational Site Charlottesville Virginia 22911

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01668667, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 23, 2021 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01668667 live on ClinicalTrials.gov.

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