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

Eisai Clinical Trials

Protocol # E2007-J000-342

Study Overview

Study Compound: E2007

Drug Name: perampanel

Registry #: NCT03201900, 2019-003734-17, JapicCTI-173644

Trial Period: Jun 2017 - Jul 2020

Indication: Partial-onset Seizures

Primary Endpoint:
1. Percentage of Participants With Partial-onset Seizures (POS) Who Achieved Seizure-free Status During the 26-week Maintenance Period of 4 mg Perampanel [Time Frame: 26 weeks in Maintenance Period of 4 mg perampanel]

Population
Study Status
Completed
Study Phase
Phase 3
Countries
Japan, Korea, Republic of See moreSee less

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Husni RE, Ngo LY, Senokuchi H, Patten A, Hiramatsu H, Watanabe K, Yamamoto T. Experience of perampanel monotherapy beyond initial titration to achieve seizure freedom in patients with focal-onset seizures with newly diagnosed or currently untreated recurrent epilepsy: A post hoc analysis of the open-label Study 342 (FREEDOM). Epilepsia Open. 2022 Mar;7(1):59-66. doi: 10.1002/epi4.12551. Epub 2021 Nov 19.

Data Sharing

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CSDR	Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type	Availability
Protocol
SAP
Sample CRF
Full CSR