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A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics When Administered as an Adjunctive Therapy in Adolescents (12 to less than 18 years of age) With Inadequately Controlled Partial-onset Seizures

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A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics When Administered as an Adjunctive Therapy in Adolescents (12 to less than 18 years of age) With Inadequately Controlled Partial-onset Seizures

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 18 Oct 2022

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At a glance

  • Drugs Perampanel (Primary)
  • Indications Partial epilepsies; Tonic-clonic epilepsy
  • Focus Therapeutic Use
  • Sponsors Eisai Inc

Most Recent Events

  • 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.
  • 08 Dec 2020 Results of post-hoc analysis from following clinical studies: double-blind studies (Phase II: 235; Phase III: 304, 305, 306, 335, 332) and their open-label extension (OLEx) phases (235 OLEx, 307, 335 OLEx, 332 OLEx) presented at the 74th Annual Meeting of the American Epilepsy Society
  • 01 May 2020 Results, post-hoc analysis of Phase II and III double blind studies and open label extension studies ( Study- 235, 304, 305,306, 332, 335 along with open label extension studies 235,307, 332 and 335) presented at the 72nd Annual Meeting of the American Academy of Neurology

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