Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Gabapentin enacarbil (GEn; GSK1838262; HORIZANT), at a dose of 600 mg/day, is currently approved in the United States for the treatment of adults with moderate-to-severe primary Restless Legs Syndrome (RLS). The aim of this study is to compare the efficacy, tolerability, and safety of GEn at lower doses (450 and 300 mg/day) as well as the already approved dose of 600 mg/day versus placebo for the treatment of subjects with moderate to severe primary RLS. This study is being conducted as a post-marketing commitment (PMC) as a condition of the approval of HORIZANT tablets (NDA 022399).
Study identification
- NCT ID
- NCT01668667
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 501 participants
Conditions and interventions
Conditions
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
- Jun 2012 (Type not available)
- Primary completion
- Nov 2013 (Actual)
- Completion
- Nov 2013 (Actual)
- Last update posted
- May 24, 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 24, 2021 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01668667 live on ClinicalTrials.gov.