Post-Marketing Surveillance of Fycompa in Korean Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Epilepsy
- Sponsor
- Eisai Korea Inc.
- Enrollment
- 3692
- Primary Endpoint
- Number of Participants With Serious Adverse Events
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Participants With Serious 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 Adverse Events
Time Frame: From the first Fycompa (Perampanel) administration date up to 24 weeks
Secondary Outcomes
- Percentage of Participants With Effective Outcome as Measured by Investigator's Clinical Global Impression of Change (CGI-C) Scores(Up to 24 weeks)