NCT03201900

Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Participants With Partial Onset Seizures (Including Secondarily Generalized Seizures (FREEDOM Study)

A Multicenter, Uncontrolled, Open-label Study and Extension Study for Verification of Eefficacy and Safety for Perampanel Monotherapy in Untreated Patients With Partial Onset Seizures (Including Secondarily Generalized Seizures) (FREEDOM Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 12 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted to evaluate the seizure-free rate of the 26-week Maintenance Period in untreated participants with partial onset seizures (POS).

Conditions

• Partial Onset Seizures

Interventions

Type	Name	Description
DRUG	E2007	Oral tablet

Timeline

• Start date: 2017-06-28
• Primary completion: 2019-02-28
• Completion: 2020-07-27
• First posted: 2017-06-28
• Last updated: 2021-08-05
• Results posted: 2020-02-25

Locations

38 sites across 2 countries: Japan, South Korea

Regulatory

• FDA-regulated drug study