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A Study to Evaluate the Effect of Gabapentin on Cardiac Repolarization in Healthy Volunteers
NCT01516372 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is XenoPort, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01516372 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01516372?
This trial is sponsored by XenoPort, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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