An observational study in Epilepsy, sponsored by Eisai Korea Inc.. Completed at 9 sites in South Korea. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2021-08-09.
Sponsored by Eisai Korea Inc. (part of Eisai Co., Ltd.) · Observational
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.
1,842 studies on the registry are indexed under Epilepsy; 423 are open to participants now.
This study's enrollment of 3,692 is above the median of 101 across 536 observational studies indexed under Epilepsy.
Browse Epilepsy studies →Eisai Korea Inc. is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male and female Korean participants who are prescribed with Fycompa (Perampanel) per the approved prescribing information will be enrolled in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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)
Exclusion Criteria:
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.
Number of Participants With Adverse Events
Time frame: From the first Fycompa (Perampanel) administration date up to 24 weeks
Number of Participants With Adverse Drug Reactions
Time frame: From the first Fycompa (Perampanel) administration date up to 24 weeks
Number of Participants With Unexpected Adverse Events
Time frame: From the first Fycompa (Perampanel) administration date up to 24 weeks
Number of Participants With Serious Adverse Events
Time frame: From the first Fycompa (Perampanel) administration date up to 24 weeks
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).
Time frame: Up to 24 weeks
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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