Epilepsy
Conditions
Keywords
Epilepsy, Partial-onset seizures, Secondarily generalized seizures, Perampanel, Post marketing surveillance, Primary generalized tonic-clonic seizures, Idiopathic generalized epilepsy
Brief summary
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.
Interventions
None listed
Sponsors
Eisai Korea Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events | From the first Fycompa (Perampanel) administration date up to 24 weeks |
| Number of Participants With Adverse Drug Reactions | From the first Fycompa (Perampanel) administration date up to 24 weeks |
| Number of Participants With Unexpected Adverse Events | From the first Fycompa (Perampanel) administration date up to 24 weeks |
| Number of Participants With Serious Adverse Events | From the first Fycompa (Perampanel) administration date up to 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Effective Outcome as Measured by Investigator's Clinical Global Impression of Change (CGI-C) Scores | Up to 24 weeks | The CGI-C score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement. Effective outcome is defined as CGI-C score of: very much improved (1), much improved (2), or minimally improved (3). |
Countries
South Korea
Outcome results
None listed