A Study of Fycompa (Perampanel) in Korean Participants

Eisai

Status: Completed

Conditions: Epilepsy

Study type: Observational

Funder types: Industry

Identifiers

NCT02722590

E2007-M065-505

Details and patient eligibility

About

The purpose of this post-marketing surveillance is to observe the following items regarding the safety profile of Fycompa (Perampanel) film-coated tablets and oral suspension in normal clinical practice setting: serious adverse event/adverse drug reaction profile, unexpected adverse event/adverse drug reaction profile, already known adverse drug reaction profile, non-serious adverse event profile and other information related to the product's safety and effectiveness.

Enrollment: 3,692 patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants with approved indication for Fycompa (Perampanel) in Korea as follows:

   • Monotherapy (film-coated tablets)

     o 4 years and older Partial-onset seizures: therapy for treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy

   • Adjunctive therapy (film-coated tablets & oral suspension)

     • 4 years and older Partial-onset seizures: therapy for treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy
     • 7 years and older Primary generalized tonic-clonic seizures: therapy for treatment of primary generalized tonic-clonic seizures in participants with idiopathic generalized epilepsy

2. Participants who have written consent for use of personal and medical information for the study purpose

Exclusion criteria

1. Hypersensitivity to the active substance or to any of the excipients of this medicine
2. In case of Fycompa film-coated tablets, Fycompa tablets contains lactose; therefore, participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. In case of Fycompa oral suspension, Fycompa suspension contains sorbitol; therefore, participants with rare hereditary problems of fructose intolerance should not take this medicine.
3. Other participants judged to be inadequate to participate in the study by doctor

Trial design

3,692 participants in 1 patient group

All Participants

Description:

Participants who are prescribed Fycompa (Perampanel) film-coated tablets and oral suspension per approved prescribing information in a normal clinical practice setting will be enrolled and observed prospectively for up to 24 Weeks.