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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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 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

NCT05533814•Eisai Korea Inc.

View on ClinicalTrials.gov

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).

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).

Eligibility

Age

4 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male and female, age 4 years or older
•2. 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)
•3. 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)

Exclusion Criteria

•1. Focal non-motor seizures only
•2. Generalized epilepsies or seizures such as absences and/or myoclonic seizures, or Lennox 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 CNS diseases, progressive tumors, and dementia), or clinically significant psychological or 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 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
•8. History of any type of brain or central nervous system surgery within 1 year before Visit 1 (baseline)
•9. Newly started ketogenic diet or has been on ketogenic diet for less than 5 weeks before Visit 1 (baseline)
•10. Multiple drug allergies or a severe drug reaction to anti-epileptic drugs (AEDs), including dermatological (example, Stevens-Johnson syndrome), hematological, or organ toxicity reactions
+9 more criteria

Locations (10)

Eisai Site #9

Cheongju-si, South Korea

Eisai Site #4

Daegu, South Korea

Eisai Site #8

Daegu, South Korea

Eisai Site #3

Daejeon, South Korea

Eisai Site #10

Jeonju, South Korea

Eisai Site #1

Seoul, South Korea

Eisai Site #2

Seoul, South Korea

Eisai Site #5

Seoul, South Korea

Eisai Site #6

Seoul, South Korea

Eisai Site #7

Seoul, South Korea

Key Dates

Start Date

October 19, 2022

Primary Completion Date

January 23, 2025

Completion Date

January 23, 2025

Last Updated

March 7, 2025

Enrollment

125

ACTUAL participants

Conditions

Epilepsy

Interventions

Perampanel

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Epilepsy; Seizure

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

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MEHMO Natural History and Biomarkers