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NCT01332305 · ClinicalTrials.gov registry record · Phase 2
Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome
A Phase 2 study, sponsored by XenoPort.
- Completed
- Registry status
- Phase 2
- Development phase
- 217
- Enrollment target
NCT01332305 is a Phase 2 study that has completed, run by XenoPort. The registered enrollment target is 217 participants.
The verdict
NCT01332305, a Phase 2 study, has completed, sponsored by XenoPort.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 217 participants
- Enrollment target
Study Summary
The objective of the study was to generate the data necessary to determine the gabapentin exposure produced by 4 dose levels of GEn (600 mg, 1200 mg, 1800 mg, and 2400 mg) or placebo, and the corresponding relief of symptoms in subjects with Restless Legs Syndrome (RLS).
Interventions
- DRUG Placebo
- DRUG GEn (XP13512/GSK1838262)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01332305
The ClinicalTrials.gov registry entry for NCT01332305 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 217 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 2 interventions - of which Placebo is the first listed.
NCT01332305 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01332305 about?
NCT01332305 is a clinical study titled "Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome". The objective of the study was to generate the data necessary to determine the gabapentin exposure produced by 4 dose levels of GEn (600 mg, 1200 mg, 1800 mg, and 2400 mg) or placebo, and the corresponding relief of symptoms in subjects with Restless Legs Syndrome (RLS).
What is the current status of trial NCT01332305?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 217 participants. The study started on 2007-01. Estimated completion is 2008-01.
What interventions are being tested in trial NCT01332305?
The interventions under investigation include: Placebo (DRUG), GEn (XP13512/GSK1838262) (DRUG).
Who is sponsoring clinical trial NCT01332305?
This trial is sponsored by XenoPort, which has 19 total clinical trials registered on ClinicalTrials.gov.
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