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: 10 Mar 2017

At a glance

  • Drugs Perampanel (Primary)
  • Indications Partial epilepsies
  • Focus Registrational; Therapeutic Use
  • Acronyms EXPLORE-305
  • Sponsors Eisai Inc
  • Most Recent Events

    • 10 Mar 2017 According to an Eisai media release, perampanel (Fycompa) has been approved in South Africa for the adjunctive treatment of partial-onset seizures. The approval was based on data from this and three other phase III studies (CTP's 35494, 36044 and 36855).
    • 06 Dec 2016 Results (n=1217) of pooled post hoc analysis demonstrating influence of pre-treatment seizure frequency on response to perampanel using patient data from EXPLORE-304, EXPLORE-305 and EXPLORE-306 trials, presented at the 70th Annual Meeting of the American Epilepsy Society
    • 06 Dec 2016 Results of pooled post-hoc analysis of safety and efficacy of perampanel in adolescent patients from six studies including this study presented at the 70th Annual Meeting of the American Epilepsy Society
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