Epilepsy
Conditions
Interventions
investigational material(s)
Generic name etc : Fycompa
INN of investigational material : Perampanel
Therapeutic category code : 113 Antiepileptics
Dosage and Administration for Investigational materia
Sponsors
Eisai Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Epilepsy participants from 12 to 17 years of age with: 1) Partial seizures (with or without secondary generalized seizures) 2) Primary generalized Tonic-clonic seizures
Exclusion criteria
Exclusion criteria: Participants previously treated with Fycompa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety 1. Number of participants with any serious adverse event 2. Number of participants with any non-serious adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy 1.Seizure frequency 2.Overall improvement rating | — |
Countries
Japan
Outcome results
None listed