EpilepsyNCT02722590
A Study of Fycompa (Perampanel) in Korean Participants
An observational study of Epilepsy, run by Eisai Korea Inc. at 9 sites in South Korea.
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… Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Epilepsy
- Type of treatment
- Pill or oral medicine
- How many people
- 3,692 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 1 Jul 2016to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male and female Korean participants who are prescribed with Fycompa (Perampanel) per the approved prescribing information will be enrolled in the study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Study site
Busan
Study site
Chungju, Chungcheong-do
Study site
Daegu
Study site
Daejeon
Study site
Gwangju, Jeolla-do
Study site
Jinju, Gyeongsang-do
Study site
Seongnam, Gyeonggji-do
Study site
Seoul
Study site
Wŏnju, Gangwon-do
About this study
Official title: Post-Marketing Surveillance of Fycompa in Korean Patients
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.
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Partial-onset seizures, Secondarily generalized seizures, Perampanel, Post marketing surveillance, Primary generalized tonic-clonic seizures, Idiopathic generalized epilepsy
- Medical subject headings
- Epilepsy, Epilepsy, Idiopathic Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Measured: From the first Fycompa (Perampanel) administration date up to 24 weeks
Number of Participants With Adverse Drug Reactions
Measured: From the first Fycompa (Perampanel) administration date up to 24 weeks
Number of Participants With Unexpected Adverse Events
Measured: From the first Fycompa (Perampanel) administration date up to 24 weeks
Number of Participants With Serious Adverse Events
Measured: From the first Fycompa (Perampanel) administration date up to 24 weeks
Secondary outcomes (1)
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).
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study start1 Jul 2016
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,692 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722590
- Sponsor's protocol ID
- E2007-M065-505
- Status last verified
- Jun 2021
- First submitted
- 24 Mar 2016
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Fycompa in Korean Patients
- ClinicalTrials.gov ID
- NCT02722590
- Acronym / sponsor ID
- E2007-M065-505
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Partial-onset seizures, Secondarily generalized seizures, Perampanel, Post marketing surveillance, Primary generalized tonic-clonic seizures, Idiopathic generalized epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,692 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | –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. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female Korean participants who are prescribed with Fycompa (Perampanel) per the approved prescribing information will be enrolled in the study.
Key inclusion criteria (7 listed)
- Participants with approved indication for Fycompa (Perampanel) in Korea as follows:
- 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
- Participants who have written consent for use of personal and medical information for the study purpose
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Percentage of Participants With Effective Outcome as Measured by Investigator's Clinical Global Impression of Change (CGI-C) Scores
Time frame: Up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Eisai Korea Inc. at 9 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: From the first Fycompa (Perampanel) administration date up to 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.