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

NCT05533814 | Completed Phase 4

• 1 other identifier: E2007-M082-606
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 10

Brief 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).

Conditions

Epilepsy

Keywords

Epilepsy; Focal onset seizures; Focal to bilateral tonic-clonic seizures; Fycompa; Seizures; Monotherapy; Open-label

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Will Achieve Seizure Freedom During the 24-weeks Maintenance Period

  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)

  Up to 48 weeks

• Percentage of Participants With at Least 50 Percent (%) and 75% Reduction in Seizure Frequency During the 24-weeks Maintenance Period

  Up to 24 weeks

• Percentage of Participants With at Least 50% and 75% Reduction in Seizure Frequency During the 24-weeks Extension Phase

  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

  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

  Baseline up to Week 24 of Maintenance Period

Study Arms (1)

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.

Drug: Perampanel

Interventions

Perampanel DRUG

Perampanel tablets.

Also known as: Fycompa, E2007

Perampanel

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Eisai Korea Inc.: lead

Study Sites (10)

Eisai Site #9

Cheongju-si, South Korea

Location

Eisai Site #4

Daegu, South Korea

Location

Eisai Site #8

Daegu, South Korea

Location

Eisai Site #3

Daejeon, South Korea

Location

Eisai Site #10

Jeonju, South Korea

Location

Eisai Site #1

Seoul, South Korea

Location

Eisai Site #2

Seoul, South Korea

Location

Eisai Site #5

Seoul, South Korea

Location

Eisai Site #6

Seoul, South Korea

Location

Eisai Site #7

Seoul, South Korea

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

perampanel

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: October 19, 2022
• Primary Completion: January 23, 2025
• Study Completion: January 23, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

KR (10)