A Study of Fycompa (Perampanel) in Korean Participants

Epilepsy Clinical Trial

Official title:

Post-Marketing Surveillance of Fycompa in Korean Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722590
• Other study ID #: E2007-M065-505
• Status: Completed
• Start date: July 1, 2016
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2021
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3692
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events		From the first Fycompa (Perampanel) administration date up to 24 weeks
Primary	Number of Participants With Adverse Drug Reactions		From the first Fycompa (Perampanel) administration date up to 24 weeks
Primary	Number of Participants With Unexpected Adverse Events		From the first Fycompa (Perampanel) administration date up to 24 weeks
Primary	Number of Participants With Serious Adverse Events		From the first Fycompa (Perampanel) administration date up to 24 weeks
Secondary	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