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An Open-Label, Multicenter Study With an Extension Phase to Evaluate the Safety, Tolerability, and Exposure-Efficacy Relationship of Perampanel Oral Suspension When Administered as an Adjunctive Therapy in Pediatric Subjects (Age 4 to Less Than 12 Years) With Inadequately Controlled Partial-Onset Seizures or Primary Generalized Tonic Clonic Seizures

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Trial Profile

An Open-Label, Multicenter Study With an Extension Phase to Evaluate the Safety, Tolerability, and Exposure-Efficacy Relationship of Perampanel Oral Suspension When Administered as an Adjunctive Therapy in Pediatric Subjects (Age 4 to Less Than 12 Years) With Inadequately Controlled Partial-Onset Seizures or Primary Generalized Tonic Clonic Seizures

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Aug 2023

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At a glance

  • Drugs Perampanel (Primary)
  • Indications Generalised seizures; Partial epilepsies; Tonic-clonic epilepsy
  • Focus Adverse reactions; Registrational
  • Acronyms Study 311
  • Sponsors Eisai Co Ltd; Eisai Inc

    • Most Recent Events

    • 01 Aug 2023 Results of subgroup analysis (n=65 Japanese patient in the Core Study) assessing safety and efficacy of adjunctive perampanel in pediatric patients with inadequately controlled focal-onset seizures published in the Seizure: European Journal of Epilepsy
    • 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 Sep 2021 Results assessing efficacy and safety of adjunctive perampanel 4 mg/day in paediatric patients (aged 4 -12 years) with FOS (with/without FBTCS) or GTCS, presented at the 34th International Epilepsy Congress
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