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NCT01668667 · ClinicalTrials.gov registry record · Phase 4
Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study
A Phase 4 study, sponsored by XenoPort.
- Completed
- Registry status
- Phase 4
- Development phase
- 501
- Enrollment target
NCT01668667 is a Phase 4 study that has completed, run by XenoPort. The registered enrollment target is 501 participants.
The verdict
NCT01668667, a Phase 4 study, has completed, sponsored by XenoPort.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 501 participants
- Enrollment target
Study 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).
Interventions
- DRUG GSK1838262 600 mg
- DRUG GSK1838262 450 mg
- DRUG GSK1838262 300 mg
- DRUG GSK1838262 Placebo match
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 501 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01668667
The ClinicalTrials.gov registry entry for NCT01668667 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 501 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is XenoPort, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which GSK1838262 600 mg is the first listed.
NCT01668667 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01668667 about?
NCT01668667 is a clinical study titled "Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study". 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 d...
What is the current status of trial NCT01668667?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 501 participants. The study started on 2012-06. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01668667?
The interventions under investigation include: GSK1838262 600 mg (DRUG), GSK1838262 450 mg (DRUG), GSK1838262 300 mg (DRUG), GSK1838262 Placebo match (DRUG).
Who is sponsoring clinical trial NCT01668667?
This trial is sponsored by XenoPort, which has 19 total clinical trials registered on ClinicalTrials.gov.
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