An Open-label Pilot Study With an Extension Phase to Evaluate the Pharmacokinetics, and to Generate Preliminary Safety, Tolerability, and Efficacy of Perampanel (E2007) Oral Suspension When Given as an Adjunctive Therapy in Pediatric Subjects From 2 to Less Than 12 Years of Age With Epilepsy

Trial Profile

An Open-label Pilot Study With an Extension Phase to Evaluate the Pharmacokinetics, and to Generate Preliminary Safety, Tolerability, and Efficacy of Perampanel (E2007) Oral Suspension When Given as an Adjunctive Therapy in Pediatric Subjects From 2 to Less Than 12 Years of Age With Epilepsy

Completed
Phase of Trial: Phase II

Latest Information Update: 31 May 2018

At a glance

  • Drugs Perampanel (Primary)
  • Indications Epilepsy
  • Focus Pharmacokinetics
  • Sponsors Eisai Inc
  • Most Recent Events

    • 31 May 2018 According to an Eisai Inc media release, based on the interim data of Study 311 and data from Study 232,the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Eisai's antiepileptic drug (AED) Fycompa and FDA has designated this application for Priority Review, which means the review period will be six months.The FDA has assigned a Prescription Drug User Fee Act action date of September September 28, 2018.
    • 30 Mar 2018 According to an Eisai Inc media release, the submission also proposes a pediatric indication for monotherapy and adjunctive use for primary generalized tonic-clonic seizures (PGTC) in children (ages 2 -12 years) with epilepsy. The sNDA is for both the FYCOMPA tablet and oral suspension formulations.
    • 30 Mar 2018 According to an Eisai Inc media release, based on the interim data of Study 311 and data from Study 232, the company has submitted a supplemental New Drug Application (sNDA) for priority review to the U.S. Food and Drug Administration (FDA) for FYCOMPA CIII as monotherapy and adjunctive use for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in pediatric patients (ages 2 to less than 12 years).
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