A Phase 4 interventional study of Perampanel in Epilepsy, sponsored by Eisai Korea Inc.. Completed at 10 sites in Korea, Republic of. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by Eisai Korea Inc. (part of Eisai Co., Ltd.) · Phase 4, Interventional, and Treatment
Among 28 studies testing perampanel in Epilepsy — none open to participants now, 1 under way, none of them phase 3. perampanel · Epilepsy.
Among the 28 studies testing perampanel in Epilepsy, this one is the 6th largest by enrollment of the 27 interventional ones that give a count, is one of 2 that started in 2022, is one of 10 in phase 4, and was the 24th registered.
1,848 studies on the registry are indexed under Epilepsy; 420 are open to participants now.
Browse Epilepsy studies →None of the 28 studies testing perampanel in Epilepsy is open now. The open studies under Epilepsy, anywhere →
perampanel: first FDA approval 2012 (FYCOMPA), first EMA approval 2012. What it is approved for, and how studies give it, is on its page →
Of the 283 Epilepsy studies recruiting now, 112 (40%) set no upper age limit and 148 (52%) stop at 75 or younger; 140 take children under 18; 55 take healthy volunteers.
This study: 4 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
28 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 2 started in 2022.
This study's enrollment of 125 is above the median of 50 across 1,239 interventional studies indexed under Epilepsy.
Median enrollment 26 across the 27 interventional studies. Of the 25 that completed or were terminated, 16 (64%) have results posted.
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20 of 28 have an industry lead sponsor. The 10 most frequent:
This study is registered under Eisai Korea Inc., one of the names counted as Eisai Co., Ltd.. Under that name alone:
Eisai Korea Inc. is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
51 studies in Epilepsy by Eisai Co., Ltd.: none open now, 1 under way, none of them phase 3. Of 48 finished, 30 (63%) have results posted.
Among the 51 studies in Epilepsy by Eisai Co., Ltd., this one is the 17th largest by enrollment of the 42 interventional ones that give a count, is the only one that started in 2022, is one of 12 in phase 4, and was the 51st registered.
Eisai Co., Ltd.’s Epilepsy studies by the year they started, since 2002.
1 of the studies testing perampanel in Epilepsy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04015141Eisai Inc.A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy | 2027-04-06 |
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Among the 28 studies testing perampanel in Epilepsy, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Eisai Co., Ltd.’s 51 in Epilepsy:
Nothing recorded among them since 2026-09-25.
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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).
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Perampanel
Perampanel tablets.
Also known as: Fycompa, E2007
Percentage of Participants Who Will Achieve Seizure Freedom During the 24-weeks Maintenance Period
Time frame: Up to 24 weeks
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
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.
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
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.
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
The retention rate is defined as the percentage of participants remaining on perampanel treatment at the end of Maintenance Period after initiating treatment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 60 weeks
Number of Participants With Clinically Significant Laboratory Values
Laboratory parameters will include hematology and blood chemistry.
Time frame: Up to 60 weeks
Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
No publications or documents are linked to this record.
Ran from Oct 2022 to primary completion in Jan 2025, 27 months.
Of 43 phase 4 interventional studies under Epilepsy, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's 27 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Perampanel