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A Double-blind, Randomized, Placebo-controlled, Multicenter, Parallel-group Study with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Adjunctive Perampanel in Primary Generalized Tonic-Clonic Seizures

Trial Profile

A Double-blind, Randomized, Placebo-controlled, Multicenter, Parallel-group Study with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Adjunctive Perampanel in Primary Generalized Tonic-Clonic Seizures

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Jan 2023

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At a glance

  • Drugs Perampanel (Primary)
  • Indications Generalised seizures; Tonic-clonic epilepsy
  • Focus Registrational; Therapeutic Use
  • Sponsors Eisai Inc
  • Most Recent Events

    • 06 Dec 2022 Results of post hoc pooled analysis of Phase III Studies 332 (NCT01393743) and 311 (NCT02849626), and Phase II Study 232 (NCT01527006) to assess the effect of adjunctive perampanel on myoclonic or absence seizure-free days presented at the 76th Annual Meeting of the American Epilepsy Society
    • 01 Oct 2022 Results of post-hoc analysis of open-label extension studies (Study 307, Study 235, Study 332 and Study 335) assessing long-term efficacy and safety of adjunctive perampanel in adolescent patients with focal-onset seizures (FOS), with/without focal to bilateral tonic-clonic seizures (FBTCS), or generalized tonic-clonic seizures, published in the Epilepsy and Behavior.
    • 14 Sep 2022 Results published in the Epilepsia
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