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

Last updated: March 6, 2025
Sponsor: Eisai Korea Inc.
Overall Status: Completed

Phase

4

Condition

Epilepsy

Treatment

Perampanel

Clinical Study ID

NCT05533814
E2007-M082-606
  • Ages > 4
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and female, age 4 years or older

  2. Diagnosis of epilepsy with FOS with or without FBTCS according to the InternationalLeague Against Epilepsy (ILAE) Classification of Epileptic Seizures (2017),established by clinical history and an electroencephalogram (EEG)

  3. Newly diagnosed or recurrent epilepsy with at least 2 unprovoked seizures (excludingfocal non-motor seizures) separated by a minimum of 24 hours in the 1 year beforeVisit 1 (baseline)

Exclusion

Exclusion Criteria:

  1. Focal non-motor seizures only

  2. Generalized epilepsies or seizures such as absences and/or myoclonic seizures, orLennox Gastaut syndrome

  3. History of status epilepticus within 1 year before Visit 1 (baseline)

  4. History of psychogenic non-epileptic seizures within 5 years before Visit 1 (baseline)

  5. Progressive central nervous system (CNS) disease (including degenerative CNSdiseases, progressive tumors, and dementia), or clinically significant psychologicalor neurological disorders

  6. History of suicidal ideation/attempt within 5 years before Visit 1 (baseline)

  7. Evidence of clinically significant active hepatic disease, or other clinicallysignificant disease (example, cardiac, respiratory, gastrointestinal, renal disease)that in the opinion of the investigators could affect the participant safety orinterfere with the study assessments

  8. History of any type of brain or central nervous system surgery within 1 year beforeVisit 1 (baseline)

  9. Newly started ketogenic diet or has been on ketogenic diet for less than 5 weeksbefore Visit 1 (baseline)

  10. Multiple drug allergies or a severe drug reaction to anti-epileptic drugs (AEDs),including dermatological (example, Stevens-Johnson syndrome), hematological, ororgan toxicity reactions

  11. Hypersensitive to perampanel or ingredients of this drug

  12. Participant with genetic problems including galactose intolerance, Lapp lactasedeficiency, or glucose-galactose malabsorption

  13. Use of intermittent rescue medication on 2 or more occasions within 4 weeks beforeVisit 1 (baseline)

  14. History of receiving any AED (except for occasional use less than 2 weeks of AEDs asrescue treatment), antipsychotics, or anti-anxiety drugs within 12 weeks beforeVisit 1 (baseline)

  15. History of receiving any AED (including rescue treatment) for more than 2 weeks intotal within 2 years before Visit 1 (baseline)

  16. Has received prior treatment with perampanel

  17. Females of child bearing potential who are breastfeeding or pregnant at Visit 1 (baseline), or who do not consent to employ contraception

  18. Currently enrolled in another clinical study or have used any investigationaldrug/biologics or device within 28 days or 5*half-life, whichever is longer

  19. Participant who did not consent to having at least 2 weeks of washout period beforeVisit 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)

Study Design

Total Participants: 125
Treatment Group(s): 1
Primary Treatment: Perampanel
Phase: 4
Study Start date:
October 19, 2022
Estimated Completion Date:
January 23, 2025

Study 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).

Connect with a study center

  • Eisai Site #9

    Cheongju,
    Korea, Republic of

    Site Not Available

  • Eisai Site #4

    Daegu,
    Korea, Republic of

    Site Not Available

  • Eisai Site #8

    Daegu,
    Korea, Republic of

    Site Not Available

  • Eisai Site #3

    Daejeon,
    Korea, Republic of

    Site Not Available

  • Eisai Site #10

    Jeonju,
    Korea, Republic of

    Site Not Available

  • Eisai Site #1

    Seoul,
    Korea, Republic of

    Site Not Available

  • Eisai Site #2

    Seoul,
    Korea, Republic of

    Site Not Available

  • Eisai Site #5

    Seoul,
    Korea, Republic of

    Site Not Available

  • Eisai Site #6

    Seoul,
    Korea, Republic of

    Site Not Available

  • Eisai Site #7

    Seoul,
    Korea, Republic of

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.