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

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Mar 2018

At a glance

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

    • 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 this trial 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).
    • 02 Mar 2018 This trial has been completed in Italy.
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