CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 501 enrolled
Drug / intervention
GSK1838262 600 mg +3 moredrug
Likely dose
GSK1838262 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01668667
NCT01668667Phase 4Completed
CompareCT.gov

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

XenoPort, Inc.·interventional·Posted Aug 20, 2012·Updated May 24, 2021

In Brief

A Phase 4 clinical trial evaluating GSK1838262 600 mg, GSK1838262 450 mg, and 2 other interventions for Restless Legs Syndrome. Completed, enrolled 501 participants across 42 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 20, 2012
Enrollment StartJun 1, 2012
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.9 years ago

Interventions

GSK1838262 600 mgdrug

Drug: GSK1838262 600 mg/day Comparison of 3 doses

GSK1838262 450 mgdrug

Drug: GSK1838262 450 mg/day Comparison of 3 doses

GSK1838262 300 mgdrug

Drug: GSK1838262 300 mg/day Comparison of 3 doses

GSK1838262 Placebo matchdrug

Drug; GSK1838262 placebo to match 600 mg, 450 mg, 300 mg doses