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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: Completed Phase 2 study, sponsored by XenoPort.
NCT01332305 is a Phase 2 study that has completed, run by XenoPort. The registered enrollment target is 217 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Css, max is defined as the maximum or "peak" concentration of a drug observed after multiple administration, at steady state. Css, max is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Css, min is defined as the minimum concentration of a drug observed after its administration, in steady state. ng, nanograms; PK, pharmacokinetic; W, week; BLQ, below limit of quantitation.
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 |
What the finished NCT01332305 record still lists
NCT01332305 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01332305 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01332305's enrollment target sits among peer trials
217 286th of 2000 higher than 1,715 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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