Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures
Condition: Partial-Onset or Primary Generalized Tonic-Clonic Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, multicenter study with an Extension Phase to evaluate the safety and
      tolerability of perampanel oral suspension when administered as an adjunctive therapy in
      children (ages 4 to less than [<] 12 years) with inadequately controlled partial onset
      seizures (POS) or primary generalized tonic clonic (PGTC) seizures.
    

Detailed description: 
      This is a multicenter, open-label, single-arm study in children (age 4 to <12 years) with
      inadequately controlled POS or PGTC seizures. The study will consist of a Core Phase and two
      Extension Phases (Extension Phase A [for all countries in the study], and Extension Phase B
      [available for participants enrolled in Japan and in countries where an extended access
      program {EAP} cannot be implemented, after completion of Extension Phase A]). The Core Phase
      will consist of the following 2 phases: Pretreatment and Treatment Phase. The Pretreatment
      Phase, during which participants will be assessed for eligibility, will consist of up to a
      4-weeks +/- 3 days Screening/Baseline Period. The Treatment Phase will consist of 3 periods:
      Titration Period (up to an 11-weeks: dose titration on the basis of individual clinical
      response and tolerability), Maintenance Period (up to a 12-weeks: continuation of perampanel
      oral suspension once daily at the dose level achieved at the end of the Titration Period),
      and Follow-up Period (up to 4-weeks +/- 7 days: only for those participants not entering into
      Extension Phase A or those who prematurely discontinue from the study). Extension Phase A
      will consist of up to 29-weeks Maintenance Period and up to 4-weeks +/- 7 days Follow-up
      Period after the last dose of perampanel only for participants who did not enter into
      Extension Phase B. All participants who complete all scheduled visits up to and including
      Visit 9 in the Treatment Phase will be eligible to participate in Extension Phase A of the
      study. During the Maintenance Period of Extension Phase A, all participants will continue
      with their optimal perampanel dose (that is, dose level that they complete on during the Core
      Phase). After completing Extension Phase A, participants in Japan and in countries where EAP
      cannot be implemented, participants will be eligible to participate in Extension Phase B. In
      Japan, treatment will continue as long as clinically appropriate according to the judgment of
      the investigator. However, treatment of participants in Extension B will be completed when
      the participant reaches 12 years of age or when perampanel is commercially available in Japan
      for treatment of POS in pediatric participants (4 to less than 12 years of age). In countries
      where an EAP cannot be implemented, participation in Extension B will continue as long as
      clinically appropriate according to the judgment of the investigator, until the participants
      reaches 12 years of age or perampanel oral suspension is commercially available.
    

Intervention name(s): Perampanel
Intervention type(s): Drug
Intervention description(s): E2007
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Partial-Onset Seizures; Primary Generalized Tonic-Clonic Seizures; Adjunctive Therapy; Epilepsy