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

NCT03201900 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2021-08-05

Study results available
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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

DRUG

E2007

Oral tablet

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-28
Primary Completion
2019-02-28
Completion
2020-07-27
FDA Drug
Yes

Countries

  • Japan
  • South Korea

Study Locations

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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 NCT03201900 on ClinicalTrials.gov