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A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Trial Profile

A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2018

At a glance

  • Drugs Perampanel (Primary)
  • Indications Partial epilepsies
  • Focus Registrational; Therapeutic Use
  • Acronyms EXPLORE-304
  • Sponsors Eisai Inc
  • Most Recent Events

    • 04 Dec 2018 Results presented in an Eisai Inc media release.
    • 04 Dec 2018 According to an Eisai Inc media release, post-hoc analysis from this study were presented at the American Epilepsy Society Annual Meeting.
    • 28 Sep 2018 According to an Eisai Inc media release, based on the safety data of Study 311 and Study 232 and the efficacy data from three phase 3 pivotal studies (EXPLORE-304, 305, 306) , the US FDA has approved drug FYCOMPA (perampanel) CIII for monotherapy and adjunctive use in pediatric patients 4 years and older for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures. The approval includes both FYCOMPA tablet and oral suspension formulations.
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