Clinical trial NCT02722590: A Study of Fycompa (Perampanel) in Korean Participants
Official title: Post-Marketing Surveillance of Fycompa in Korean Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Epilepsy
Partial-onset seizures
Secondarily generalized seizures
Perampanel
Post marketing surveillance
Primary generalized tonic-clonic seizures
Idiopathic generalized epilepsy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-30
Enrollment: 3692
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female Korean participants who are prescribed with Fycompa (Perampanel) per the approved prescribing information will be enrolled in the study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From the first Fycompa (Perampanel) administration date up to 24 weeks
measure: Number of Participants With Adverse Drug Reactions
timeFrame: From the first Fycompa (Perampanel) administration date up to 24 weeks
measure: Number of Participants With Unexpected Adverse Events
timeFrame: From the first Fycompa (Perampanel) administration date up to 24 weeks
measure: Number of Participants With Serious Adverse Events
timeFrame: From the first Fycompa (Perampanel) administration date up to 24 weeks
Secondary outcomes:
measure: Percentage of Participants With Effective Outcome as Measured by Investigator's Clinical Global Impression of Change (CGI-C) Scores
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Chungju
country: Korea, Republic of
state: Chungcheong-do
city: Wonju
country: Korea, Republic of
state: Gangwon-do
city: Seongnam
country: Korea, Republic of
state: Gyeonggji-do
city: Jinju
country: Korea, Republic of
state: Gyeongsang-do
city: Gwangju
country: Korea, Republic of
state: Jeolla-do
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
References: