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

NCT03201900 | Completed Phase 3 Results FDA Drug

• 1 other identifier: E2007-J000-342
• Study Type: interventional
• Target: 91
• Locations: 2 countries
• Sites: 38

Brief 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

Keywords

perampanel

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Partial-onset Seizures (POS) Who Achieved Seizure-free Status During the 26-week Maintenance Period of 4 mg Perampanel

  A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 26-week Maintenance Period of 4 mg perampanel.

  26 weeks in Maintenance Period of 4 mg perampanel

Secondary Outcomes (8)

• Percentage of Participants With POS Who Achieved Seizure-free Status During the 26-week Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel

  26 weeks in Maintenance Period of 4 or 8 mg perampanel

• Percentage of Participants With POS Who Achieved Seizure-free Status During the 52-week Treatment Phase (26-week Maintenance Period Plus 26-week Extension Phase) of 4 mg of Perampanel

  52-week (Maintenance Period of 4 mg perampanel + Extension Phase of 4 mg perampanel)

• Percentage of Participants With POS Who Achieved Seizure-free Status During the 52-week of Treatment Phase (26-week Maintenance Period Plus 26-week Extension Phase) of Last Evaluated Dose of 4 or 8 mg Perampanel

  52-week (Maintenance Period of last evaluated dose of 4 or 8 mg perampanel + Extension Phase of 4 or 8 mg perampanel)

• Time to Onset of First Seizure From the First Dose of Study Drug in the Maintenance Period of 4 mg Perampanel

  From the first dose of study drug in the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks)

• Time to Onset of First Seizure From the First Dose of Study Drug in the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel

  From the first dose of study drug in the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks)

Study Arms (1)

E2007

EXPERIMENTAL

The Treatment Phase consists of the 4 milligrams (mg) Treatment Phase (the Titration Period \[6 weeks\] and the Maintenance Period \[26 weeks\]) and the 8 mg Treatment Phase (the Titration Period \[4 weeks\] and the Maintenance Period \[26 weeks\]) if participants require a higher dose. In the 4 mg Titration Period (6 weeks), participants will initiate 2 mg perampanel once daily (QD) for 2 weeks and then will be up-titrated to 4 mg QD and will continue this dose for 4 weeks. If participants have no safety issues at the end of the Titration Period, they will start the 4 mg Maintenance Period for 26 weeks. Participants will only need the higher dose if they are having seizures. In the 8 mg Titration Period (4 weeks), participants will be administered 6 mg perampanel QD for 2 weeks and then will be up-titrated to 8 mg QD and will continue this dose for 2 weeks. If participants have no safety issues at the end of the Titration Period, they will start the 8 mg Maintenance Period for 26 weeks.

Drug: E2007

Interventions

E2007 DRUG

Oral tablet

Also known as: Perampanel, Fycompa, 2-(2-Oxo-1-phenyl-5-pyridin-2-yl-1,2-dihydropyridin-3-yl) benzonitrile hydrate (4:3)

E2007

Eligibility Criteria

• Age: 12 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Be considered reliable and willing to be available for the study period and are able to record seizures and report adverse events (AEs) himself/herself or have a caregiver who can record seizures and report AEs for them
• Participants who are newly diagnosed or recurrent epilepsy and have experienced at least 2 unprovoked seizures separated by a minimum of 24 hours in the 1 year prior to the Pretreatment Phase
• Participants who have excluded the progressive central nervous system (CNS) abnormality occurring seizures by computed tomography (CT) or magnetic resonance imaging (MRI)
• Participants who have had a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history and an electroencephalogram (EEG) that is consistent with localization-related epilepsy; normal interictal EEGs will be allowed provided that the participant meets the other diagnosis criterion (ie, clinical history)

You may not qualify if:

• Participants who present only simple partial seizures without motor signs
• Participants who have seizure clusters where individual seizures cannot be counted
• Participants who present or have a history of Lennox-Gastaut syndrome
• Participants who have a history of status epilepticus
• Participants who have a history of psychogenic non-epileptic seizures
• Participants who have a history of suicidal ideation/attempt
• Participants who present clinically problematic psychological or neurological disorder(s)
• Evidence of clinically significant disease
• Evidence of clinically significant active hepatic disease
• A prolonged time from the beginning of the QRS complex to the end of the T wave (QT) interval corrected for heart rate
• Participants who have a history of receiving any AEDs (except for AEDs used as rescue treatment), antipsychotics or anti-anxiety drugs within 12 weeks prior to the Pretreatment Phase
• Participants who have not used a stable dose of antidepressant in the 12 weeks
• Participants who have a history of any type of surgery for brain or central nervous system within 1 year
• Participants who have a history of receiving any AED (including AED used as rescue treatment) for more than 2 weeks
• Participants who have used intermittent rescue benzodiazepines on 2 or more occasions within 4 weeks

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (38)

Eisai Trial Site #18

Aichi, Japan

Location

Eisai Trial Site #19

Aichi, Japan

Location

Eisai Trial Site #11

Fukuoka, Japan

Location

Eisai Trial Site #29

Fukuoka, Japan

Location

Eisai Trial Site #4

Hiroshima, Japan

Location

Eisai Trial Site #16

Hokkaido, Japan

Location

Eisai Trial Site #8

Hokkaido, Japan

Location

Eisai Trial Site #14

Hyōgo, Japan

Location

Eisai Trial Site #6

Hyōgo, Japan

Location

Eisai Trial Site #7

Kagoshima, Japan

Location

Eisai Trial Site #9

Kanagawa, Japan

Location

Eisai Trial Site #10

Kyoto, Japan

Location

Eisai Trial Site #30

Miyagi, Japan

Location

Eisai Trial Site #25

Nagasaki, Japan

Location

Eisai Trial Site #27

Nagasaki, Japan

Location

Eisai Trial Site #15

Nara, Japan

Location

Eisai Trial Site #12

Niigata, Japan

Location

Eisai Trial Site #21

Osaka, Japan

Location

Eisai Trial Site #24

Osaka, Japan

Location

Eisai Trial Site #26

Osaka, Japan

Location

Eisai Trial Site #3

Saitama, Japan

Location

Eisai Trial Site #5

Saitama, Japan

Location

Eisai Trial Site #1

Shizuoka, Japan

Location

Eisai Trial Site #22

Tochigi, Japan

Location

Eisai Trial Site #28

Tokushima, Japan

Location

Eisai Trial Site #20

Tokyo, Japan

Location

Eisai Trial Site #23

Tokyo, Japan

Location

Eisai Trial Site #31

Tokyo, Japan

Location

Eisai Trial Site #13

Yamagata, Japan

Location

Eisai Trial Site #17

Yamaguchi, Japan

Location

Eisai Trial Site #32

Yamaguchi, Japan

Location

Eisai Trial Site #38

Gyeonggi-do, South Korea

Location

Eisai Trial Site #36

Incheon, South Korea

Location

Eisai Trial Site # 2

Seoul, South Korea

Location

Eisai Trial Site #33

Seoul, South Korea

Location

Eisai Trial Site #34

Seoul, South Korea

Location

Eisai Trial Site #35

Seoul, South Korea

Location

Eisai Trial Site #37

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 34657389 DERIVED

MeSH Terms

Interventions

perampanel

Results Point of Contact

• Title: Inquiry Service.
• Organization: Eisai, Inc.

eisai-chiken_hotline@hhc.eisai.co.jp

none

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 28, 2017
• Study Start: June 28, 2017
• Primary Completion: February 28, 2019
• Study Completion: July 27, 2020
• Last Updated: August 5, 2021
• Results First Posted: February 25, 2020

Record last verified: 2020-02

Locations

KR (7); JP (31)