drugset / Trial / NCT05533814

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

Phase 4 Completed 125 enrolled Eisai Co., Ltd.
NaSingle-groupOpen-labelTreatment

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).

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Perampanel Small molecule 8 mg Oral

Indications