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A Multicenter, Uncontrolled, Open-label Study and Extension Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Patients With Partial Onset Seizures (Including Secondarily Generalized Seizures)

Trial Profile

A Multicenter, Uncontrolled, Open-label Study and Extension Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Patients With Partial Onset Seizures (Including Secondarily Generalized Seizures)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2019

At a glance

  • Drugs Perampanel (Primary)
  • Indications Partial epilepsies
  • Focus Registrational; Therapeutic Use
  • Acronyms FREEDOM
  • Sponsors Eisai Co Ltd
  • Most Recent Events

    • 30 Jan 2019 According to an Eisai Co Ltd media release, based on the results of this study, the company has filed a supplementary new drug application in Japan for Fycompa (perampanel) seeking approval for use as monotherapy for partial-onset seizures.
    • 28 Nov 2018 Primary endpoint (The seizure-free rate during 26-week Maintenance Period for participants with partial onset seizures (POS)) has been met, according to an Eisai Co Ltd media release.
    • 28 Nov 2018 According to an Eisai Co Ltd media release, based on the results of this study, Eisai plans to file an application seeking approval of Fycompa as monotherapy for partial onset seizures in Japan during fiscal 2018.
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