Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy

Phase 3 Completed 306 enrolled GlaxoSmithKline Bausch Health Americas, Inc. · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).

Timeline

Start: 2005-09
Primary completion: 2008-01
Completion: 2008-01

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo - DB Phase (Titration + Maintenance) vs Retigabine - DB Phase (Titration + Maintenance); p <0.001 NCT00232596 ↗

registry analysis (superiority or other test); Placebo - Maintenance Phase vs Retigabine - Maintenance Phase; p <0.001; Fisher Exact NCT00232596 ↗

Publications

Porter RJ, Burdette DE, Gil-Nagel A, Hall ST, White R, Shaikh S, DeRossett SE. Retigabine as adjunctive therapy in adults with partial-onset seizures: integrated analysis of three pivotal controlled trials. Epilepsy Res. 2012 Aug;101(1-2):103-12. doi: 10.1016/j.eplepsyres.2012.03.010. Epub 2012 Apr 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ezogabine	Small molecule	1200 mg	Oral