CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 181 enrolled
Drug / intervention
Ezogabine: USAN Retigabine (International Nonproprietary Name)drug
Likely dose
Ezogabine: USAN Retigabine (International Nonproprietary Name) 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00310375
NCT00310375Phase 3Completed

A Multicenter, Open-label, Long-term, Safety, Tolerability and Efficacy Study of Retigabine in Adult Epilepsy Patients With Partial-onset Seizures (Extension of Study VRX-RET-E22-301)

GlaxoSmithKline·interventional·Posted Apr 3, 2006·Updated Jul 31, 2020

In Brief

A Phase 3 clinical trial evaluating Ezogabine: USAN Retigabine (International Nonproprietary Name) for Epilepsy. Completed, enrolled 181 participants across 51 sites in 5 countries.

Detailed Summary

The purpose of this study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of long-term treatment with retigabine and patient quality of life will also be assessed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesArgentina, Brazil, Canada, Mexico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 3, 2006
Enrollment StartMay 1, 2006
Primary CompletionNov 30, 2016
Study CompletionMar 15, 2017
TodayJul 2, 2026
Enrollment to primary: 10.6 yearsPosted 20.2 years ago

Interventions

Ezogabine: USAN Retigabine (International Nonproprietary Name)drug

Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patient receives between 600 and 1200 mg of retigabine per day. The duration will be until the trial concludes or the patient leaves the trial.