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NCT01480609 · ClinicalTrials.gov registry record · Phase 1

Effect of Haemodialysis on the Pharmacokinetics of Ezogabine/Retigabine and Its N-acetyl Metabolite

A Phase 1 study of Epilepsy, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
8
Enrollment target
1
Study location

NCT01480609 is a Phase 1 study of Epilepsy that has completed, run by GlaxoSmithKline. The registered enrollment target is 8 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01480609, a Phase 1 study of Epilepsy, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
8 participants
Enrollment target
1
Study location

Study Summary

This in an open-label, single dose, fixed sequence, two treatment period study enrolling 8 patients (to obtain 6 evaluable) with end stage renal disease (ESRD) receiving haemodialysis. Patients will remain in the unit during each treatment period from admission to the collection of the final PK sample. The doses of ezogabine/retigabine in the two treatment periods will be separated by at least 7 days.

Conditions Studied

Interventions

  • DRUG Retigabine / Ezogabine

Study Locations (1)

Minnesota

  • GSK Investigational Site - Minneapolis

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2011-11-30
Est. Completion 2012-04-24
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT01480609

The ClinicalTrials.gov registry entry for NCT01480609 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (99% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which Retigabine / Ezogabine is the first listed.

NCT01480609 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT01480609 about?

NCT01480609 is a clinical study titled "Effect of Haemodialysis on the Pharmacokinetics of Ezogabine/Retigabine and Its N-acetyl Metabolite". This in an open-label, single dose, fixed sequence, two treatment period study enrolling 8 patients (to obtain 6 evaluable) with end stage renal disease (ESRD) receiving haemodialysis. Patients will remain in the unit during each treatment period from admission to the collection of the final PK samp...

What is the current status of trial NCT01480609?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2011-11-30. Estimated completion is 2012-04-24.

What conditions does trial NCT01480609 study?

This clinical trial studies the following conditions: Epilepsy.

What interventions are being tested in trial NCT01480609?

The interventions under investigation include: Retigabine / Ezogabine (DRUG).

Who is sponsoring clinical trial NCT01480609?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01480609 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.