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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Apr 2017

At a glance

  • Drugs Retigabine (Primary)
  • Indications Partial epilepsies
  • Focus Registrational; Therapeutic Use
  • Acronyms RESTORE-2
  • Sponsors GlaxoSmithKline; Valeant Pharmaceuticals International
  • Most Recent Events

    • 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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