A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase 3 Study to Determine the Efficacy and Safety of Two Doses of Retigabine (900 Mg/Day and 600 Mg/Day) Used as Adjunctive Therapy in Refractory Epilepsy Patients With Partial-Onset Seizures
Phase of Trial: Phase III
Latest Information Update: 13 Jul 2018
At a glance
- Drugs Retigabine (Primary)
- Indications Partial epilepsies
- Focus Registrational; Therapeutic Use
- Acronyms RESTORE-2
- Sponsors Bausch Health Companies; GlaxoSmithKline; Valeant Pharmaceuticals International
- 03 Dec 2010 Results presented as an abstract at the 64th Annual Meeting of the American Epilepsy Society.
- 28 Sep 2010 Completers population analysis results from RESTORE 1 and RESTORE 2 presented at the 14th Congress of the European Federation of Neurological Societies.
- 11 Aug 2010 A US FDA advisory committee voted unanimously that this pivotal study and RESTORE 1 had provided substantial evidence of the effectiveness of ezogabine [retigatine] as adjunctive treatment for adults with partial-onset seizures.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History