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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

NCT05533814 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2025-03-07

No results posted yet for this 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).

Conditions

Interventions

DRUG

Perampanel

Perampanel tablets.

Sponsors & Collaborators

  • Eisai Korea Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-19
Primary Completion
2025-01-23
Completion
2025-01-23

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05533814 on ClinicalTrials.gov