EpilepsyPhase 4NCT05533814
A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants With Focal Onset Seizures With or Without Focal to Bilateral Tonic-clonic Seizures
A Phase 4 study testing Perampanel in people with Epilepsy, run by Eisai Korea Inc. at 10 sites in South Korea.
Trial summary
The primary purpose of this study is to evaluate the efficacy of perampanel monotherapy measured by the seizure-free rate during the Maintenance Period (24 weeks) of the Treatment Phase in untreated participants with focal onset seizures (FOS) with or without focal to bilateral tonic-clonic seizures (FBTCS). Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Perampanel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 19 Oct 2022to 23 Jan 2025
- Phase
- Phase 4
- 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
Who may be able to join
- Male and female, age 4 years or older
- Diagnosis of epilepsy with FOS with or without FBTCS according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (2017), established by clinical history and an electroencephalogram (EEG)
- Newly diagnosed or recurrent epilepsy with at least 2 unprovoked seizures (excluding focal non-motor seizures) separated by a minimum of 24 hours in the 1 year before Visit 1 (baseline)
Who cannot join
- Focal non-motor seizures only
- Generalized epilepsies or seizures such as absences and/or myoclonic seizures, or Lennox Gastaut syndrome
- History of status epilepticus within 1 year before Visit 1 (baseline)
- History of psychogenic non-epileptic seizures within 5 years before Visit 1 (baseline)
- Progressive central nervous system (CNS) disease (including degenerative CNS diseases, progressive tumors, and dementia), or clinically significant psychological or neurological disorders
- History of suicidal ideation/attempt within 5 years before Visit 1 (baseline)
Show all 19Show fewer
- Evidence of clinically significant active hepatic disease, or other clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigators could affect the participant safety or interfere with the study assessments
- History of any type of brain or central nervous system surgery within 1 year before Visit 1 (baseline)
- Newly started ketogenic diet or has been on ketogenic diet for less than 5 weeks before Visit 1 (baseline)
- Multiple drug allergies or a severe drug reaction to anti-epileptic drugs (AEDs), including dermatological (example, Stevens-Johnson syndrome), hematological, or organ toxicity reactions
- Hypersensitive to perampanel or ingredients of this drug
- Participant with genetic problems including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Use of intermittent rescue medication on 2 or more occasions within 4 weeks before Visit 1 (baseline)
- History of receiving any AED (except for occasional use less than 2 weeks of AEDs as rescue treatment), antipsychotics, or anti-anxiety drugs within 12 weeks before Visit 1 (baseline)
- History of receiving any AED (including rescue treatment) for more than 2 weeks in total within 2 years before Visit 1 (baseline)
- Has received prior treatment with perampanel
- Females of child bearing potential who are breastfeeding or pregnant at Visit 1 (baseline), or who do not consent to employ contraception
- Currently enrolled in another clinical study or have used any investigational drug/biologics or device within 28 days or 5*half-life, whichever is longer
- Participant who did not consent to having at least 2 weeks of washout period before Visit 2, if known to take Cytochrome P4503A (CYP3A) inducing drugs or foods on Visit 1 (including, but not limited to the following) - Carbamazepine, enzalutamide, mitotane, phenytoin, phenobarbital, amobarbital, secobarbital, rifabutin, rifampicin, food containing St. John's Wort (hypericum perforatum), bosentan, efavirenz, etravirine, modafinil, armodafinil, rufinamide, nevirapine, oxcarbazepine, and glucocorticoid (except for topical use)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Eisai Site #9
Cheongju-si
Eisai Site #4
Daegu
Eisai Site #8
Daegu
Eisai Site #3
Daejeon
Eisai Site #10
Jeonju
Eisai Site #1
Seoul
Eisai Site #2
Seoul
Eisai Site #5
Seoul
Eisai Site #6
Seoul
Eisai Site #7
Seoul
About this study
Official title: A Multicenter, Open-Label, Prospective Study With an Extension Phase to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Subjects With Focal Onset Seizures With or Without Focal to Bilateral Tonic-Clonic Seizures
The primary purpose of this study is to evaluate the efficacy of perampanel monotherapy measured by the seizure-free rate during the Maintenance Period (24 weeks) of the Treatment Phase in untreated participants with focal onset seizures (FOS) with or without focal to bilateral tonic-clonic seizures (FBTCS).
Read the detailed description
The study will consist of a Core Study (36 weeks) and an Extension Phase (24 weeks). Core Study will consist of 4 weeks Pre-treatment Phase or Baseline and 32 weeks Treatment Phase (8 weeks Titration period and 24 weeks Maintenance period).
- Conditions
- Epilepsy
- Being tested
- Perampanel
- Keywords
- Epilepsy, Focal onset seizures, Focal to bilateral tonic-clonic seizures, Fycompa, Seizures, Monotherapy, Open-label
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerampanelDrug
Also called Fycompa, E2007
Perampanel tablets.
| Study group | Role | What they receive |
|---|---|---|
| Perampanel | Experimental | Participants will be administered oral perampanel at a starting dose of 2 milligram (mg) per day. Doses of perampanel will then be up titrated in increments of 2 mg every 2 weeks up to maximum of 8 mg per day at the discretion of the investigator, and the dose may be administered up to maximum tolerated dose (MTD) according to the clinical response and tolerance of individual participants. Receives: Drug: Perampanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Will Achieve Seizure Freedom During the 24-weeks Maintenance Period
Measured: Up to 24 weeks
Secondary outcomes (11)
Percentage of Participants Who Will Achieve Seizure Freedom During the Total 48-weeks Treatment Period (24-weeks Maintenance Period Plus 24-weeks Extension Phase)
Measured: Up to 48 weeks
Percentage of Participants With at Least 50 Percent (%) and 75% Reduction in Seizure Frequency During the 24-weeks Maintenance Period
50% responder rate is defined as the percentage of participants with greater than or equal to (>=) 50% reduction in seizure frequency. 75% responder rate is defined as the percentage of participants with >=75% reduction in seizure frequency.
Measured: Up to 24 weeks
Percentage of Participants With at Least 50% and 75% Reduction in Seizure Frequency During the 24-weeks Extension Phase
50% responder rate is defined as the percentage of participants with >=50% reduction in seizure frequency. 75% responder rate is defined as the percentage of participants with >=75% reduction in seizure frequency.
Measured: Up to 24 weeks
Median Percent Change From Baseline in Partial Onset Seizure Frequency per 28 Days at the End of 8 Weeks Titration Period
Measured: Baseline up to Week 8 of Titration Period
Median Percent Change From Baseline in Partial Onset Seizure Frequency per 28 days at the End of 24 Weeks Maintenance Period
Measured: Baseline up to Week 24 of Maintenance Period
Median Percent Change From Baseline in Partial Onset Seizure Frequency per 28 days at the End of 24 Weeks Extension Phase
Measured: Baseline up to Week 24 of Extension Phase
Percentage of Participants Remaining on Perampanel Treatment at the end of Maintenance Period
The retention rate is defined as the percentage of participants remaining on perampanel treatment at the end of Maintenance Period after initiating treatment.
Measured: Week 24 of Maintenance Period
Percentage of Participants Remaining on Perampanel Treatment at the end of Extension Phase
The retention rate is defined as the percentage of participants remaining on perampanel treatment at the end of Extension Phase after initiating treatment.
Measured: Week 24 of Extension Phase
Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)
A TEAE is defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline) or reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. An AE is defined as any untoward medical occurrence in a participant administered an investigational product. An AE does not necessarily have a causal relationship with a medicinal product.
Measured: Up to 60 weeks
Number of Participants With Abnormal Vital Sign Values
Vital sign parameters will include diastolic and systolic blood pressure (BP), pulse rate, respiratory rate, body temperature and body weight.
Measured: Up to 60 weeks
Number of Participants With Clinically Significant Laboratory Values
Laboratory parameters will include hematology and blood chemistry.
Measured: Up to 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start19 Oct 2022
- Primary completion23 Jan 2025
- Study completion23 Jan 2025
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 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
- NCT05533814
- Sponsor's protocol ID
- E2007-M082-606
- Status last verified
- Feb 2025
- First submitted
- 6 Sep 2022
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Prospective Study With an Extension Phase to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Subjects With Focal Onset Seizures With or Without Focal to Bilateral Tonic-Clonic Seizures
- ClinicalTrials.gov ID
- NCT05533814
- Acronym / sponsor ID
- E2007-M082-606
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Focal onset seizures, Focal to bilateral tonic-clonic seizures, Fycompa, Seizures, Monotherapy, Open-label
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 9 Sep 2022 (actual)
- 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 primary purpose of this study is to evaluate the efficacy of perampanel monotherapy measured by the seizure-free rate during the Maintenance Period (24 weeks) of the Treatment Phase in untreated participants with focal onset seizures (FOS) with or without focal to bilateral tonic-clonic seizures (FBTCS).
Detailed description
The study will consist of a Core Study (36 weeks) and an Extension Phase (24 weeks). Core Study will consist of 4 weeks Pre-treatment Phase or Baseline and 32 weeks Treatment Phase (8 weeks Titration period and 24 weeks Maintenance period).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perampanel | Experimental | Drug: PerampanelParticipants will be administered oral perampanel at a starting dose of 2 milligram (mg) per day. Doses of perampanel will then be up titrated in increments of 2 mg every 2 weeks up to maximum of 8 mg per day at the discretion of the investigator, and the dose may be administered up to maximum tolerated dose (MTD) according to the clinical response and tolerance of individual participants. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female, age 4 years or older
- Diagnosis of epilepsy with FOS with or without FBTCS according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (2017), established by clinical history and an electroencephalogram (EEG)
- Newly diagnosed or recurrent epilepsy with at least 2 unprovoked seizures (excluding focal non-motor seizures) separated by a minimum of 24 hours in the 1 year before Visit 1 (baseline)
Key exclusion criteria (19 listed)
- Focal non-motor seizures only
- Generalized epilepsies or seizures such as absences and/or myoclonic seizures, or Lennox Gastaut syndrome
- History of status epilepticus within 1 year before Visit 1 (baseline)
- History of psychogenic non-epileptic seizures within 5 years before Visit 1 (baseline)
- Progressive central nervous system (CNS) disease (including degenerative CNS diseases, progressive tumors, and dementia), or clinically significant psychological or neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PerampanelAlso: Fycompa, E2007Perampanel tablets. | Drug | Perampanel |
Primary outcome
Percentage of Participants Who Will Achieve Seizure Freedom During the 24-weeks Maintenance Period
Time frame: Up to 24 weeks
11 secondary outcomes
Percentage of Participants Who Will Achieve Seizure Freedom During the Total 48-weeks Treatment Period (24-weeks Maintenance Period Plus 24-weeks Extension Phase)
Time frame: Up to 48 weeks
Percentage of Participants With at Least 50 Percent (%) and 75% Reduction in Seizure Frequency During the 24-weeks Maintenance Period
Time frame: Up to 24 weeks
Percentage of Participants With at Least 50% and 75% Reduction in Seizure Frequency During the 24-weeks Extension Phase
Time frame: Up to 24 weeks
Median Percent Change From Baseline in Partial Onset Seizure Frequency per 28 Days at the End of 8 Weeks Titration Period
Time frame: Baseline up to Week 8 of Titration Period
Median Percent Change From Baseline in Partial Onset Seizure Frequency per 28 days at the End of 24 Weeks Maintenance Period
Time frame: Baseline up to Week 24 of Maintenance Period
Median Percent Change From Baseline in Partial Onset Seizure Frequency per 28 days at the End of 24 Weeks Extension Phase
Time frame: Baseline up to Week 24 of Extension Phase
Percentage of Participants Remaining on Perampanel Treatment at the end of Maintenance Period
Time frame: Week 24 of Maintenance Period
Percentage of Participants Remaining on Perampanel Treatment at the end of Extension Phase
Time frame: Week 24 of Extension Phase
Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 60 weeks
Number of Participants With Abnormal Vital Sign Values
Time frame: Up to 60 weeks
Number of Participants With Clinically Significant Laboratory Values
Time frame: Up to 60 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 7 Mar 2025.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Perampanel in people with Epilepsy, run by Eisai Korea Inc. at 10 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 3 inclusion and 19 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 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of Participants Who Will Achieve Seizure Freedom During the 24-weeks Maintenance Period (time frame: Up to 24 weeks). 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 7 Mar 2025.