A Study of Fycompa (Perampanel) in Korean Participants

Study Overview
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Brief Summary
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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.

Official Title
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Post-Marketing Surveillance of Fycompa in Korean Patients

Conditions
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Epilepsy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Participants who have written consent for use of personal and medical information for the study purpose Exclusion Criteria: Hypersensitivity to the active substance or to any of the excipients of this medicine 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. Other participants judged to be inadequate to participate in the study by doctor

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Participants<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Effective Outcome as Measured by Investigator's Clinical Global Impression of Change (CGI-C) Scores | 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). | Up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Partial-onset seizures, Secondarily generalized seizures, Perampanel, Post marketing surveillance, Primary generalized tonic-clonic seizures, Idiopathic generalized epilepsy