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

NCT01668667 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2021-05-24

Study results available
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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).

Conditions

  • Restless Legs Syndrome

Interventions

DRUG

GSK1838262 600 mg

Drug: GSK1838262 600 mg/day Comparison of 3 doses

DRUG

GSK1838262 450 mg

Drug: GSK1838262 450 mg/day Comparison of 3 doses

DRUG

GSK1838262 300 mg

Drug: GSK1838262 300 mg/day Comparison of 3 doses

DRUG

GSK1838262 Placebo match

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

Sponsors & Collaborators

  • XenoPort, Inc.

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01668667 on ClinicalTrials.gov