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NCT01516372 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect of Gabapentin on Cardiac Repolarization in Healthy Volunteers
A Phase 1 study of Restless Legs Syndrome, sponsored by XenoPort.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT01516372 is a Phase 1 study of Restless Legs Syndrome that has completed, run by XenoPort. The registered enrollment target is 52 participants, below the 93-participant average among 14 other Restless Legs Syndrome trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01516372, a Phase 1 study of Restless Legs Syndrome, has completed, sponsored by XenoPort.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a randomized, double-blind, placebo- controlled cross-over study to investigate the effect of GEn on cardiac repolarisation parameters compared with placebo and a positive control, moxifloxacin. Approximately 52 subjects will be recruited to the study and will take part in four dosing sessions. Subjects will receive, in a randomized order, a single dose of 1200 mg GEn, 6000 mg GEn (supratherapeutic dose), 400 mg moxifloxacin (positive control) and placebo. Twelve lead continuous ECG monitoring will be conducted from pre-dose to approximately 24 hours after dosing on Day 1 of each study session. The primary comparison of interest will be the mean change from baseline in the time-matched differences in QTcF between each GEn treatment and placebo.
Conditions Studied
Interventions
- DRUG Moxifloxacin
- DRUG Moxifloxacin Placebo
- DRUG GEn 1200mg
- DRUG Gen 6000 mg
- DRUG GEn Placebo
Study Locations (1)
Texas
- GSK Investigational Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01516372
The ClinicalTrials.gov registry entry for NCT01516372 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 93-participant average among 14 other Restless Legs Syndrome trials with a reported enrollment target (44% lower). The listed sponsor is XenoPort, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Restless Legs Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Moxifloxacin is the first listed.
NCT01516372 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01516372 about?
NCT01516372 is a clinical study titled "A Study to Evaluate the Effect of Gabapentin on Cardiac Repolarization in Healthy Volunteers". This will be a randomized, double-blind, placebo- controlled cross-over study to investigate the effect of GEn on cardiac repolarisation parameters compared with placebo and a positive control, moxifloxacin. Approximately 52 subjects will be recruited to the study and will take part in four dosing s...
What is the current status of trial NCT01516372?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2012-01. Estimated completion is 2012-03.
What conditions does trial NCT01516372 study?
This clinical trial studies the following conditions: Restless Legs Syndrome.
What interventions are being tested in trial NCT01516372?
The interventions under investigation include: Moxifloxacin (DRUG), Moxifloxacin Placebo (DRUG), GEn 1200mg (DRUG), Gen 6000 mg (DRUG), GEn Placebo (DRUG).
Who is sponsoring clinical trial NCT01516372?
This trial is sponsored by XenoPort, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01516372 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.