A Study of Fycompa (Perampanel) in Korean Participants

Completed

• Conditions: Epilepsy

• Registration Number: NCT02722590
• Lead Sponsor: Eisai Korea Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-30
• Study Start: 2016-07-01
• Status Verified: 2021-06
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3692

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Serious 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 Adverse Events	From the first Fycompa (Perampanel) administration date up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
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).