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

NCT ID: NCT03201900

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-28
• Study Completion Date: 2020-07-27

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

E2007

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.

Group Type: EXPERIMENTAL

E2007

Intervention Type: DRUG

Oral tablet

Interventions

E2007

Oral tablet

Intervention Type: DRUG

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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
• Participants who have a history of receiving any AED polytherapy
• Participants who experienced treatment with perampanel
• Participants who have had non-constant ketogenic diet within 4 weeks
• Participants who have a history of drug or alcohol dependency or abuse
• Participants who have had multiple drug allergies or a severe drug reaction to an AED(s)
• Females who are breastfeeding or pregnant in the Pretreatment Phase (as documented by a positive beta-human chorionic gonadotropin [β-hCG] test)
• Females of childbearing potential who:

• Within 28 days before the start of the Pretreatment Phase, did not use a highly effective method of contraception, which includes any of the following:

• total abstinence (if it is their preferred and usual lifestyle);
• an intrauterine device or intrauterine hormone-releasing system (IUS);
• a contraceptive implant;
• an oral contraceptive (with additional barrier method) (Participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation);
• have a vasectomized partner with confirmed azoospermia
• Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation
• Participants who have participated in a study involving administration of an investigational drug or device within 4 weeks before Visit 1, or within approximately 5 half-lives of the previous investigational compound, whichever is longer

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eisai Trial Site #18

Aichi, , Japan

Eisai Trial Site #19

Aichi, , Japan

Eisai Trial Site #11

Fukuoka, , Japan

Eisai Trial Site #29

Fukuoka, , Japan

Eisai Trial Site #4

Hiroshima, , Japan

Eisai Trial Site #16

Hokkaido, , Japan

Eisai Trial Site #8

Hokkaido, , Japan

Eisai Trial Site #14

Hyōgo, , Japan

Eisai Trial Site #6

Hyōgo, , Japan

Eisai Trial Site #7

Kagoshima, , Japan

Eisai Trial Site #9

Kanagawa, , Japan

Eisai Trial Site #10

Kyoto, , Japan

Eisai Trial Site #30

Miyagi, , Japan

Eisai Trial Site #25

Nagasaki, , Japan

Eisai Trial Site #27

Nagasaki, , Japan

Eisai Trial Site #15

Nara, , Japan

Eisai Trial Site #12

Niigata, , Japan

Eisai Trial Site #21

Osaka, , Japan

Eisai Trial Site #24

Osaka, , Japan

Eisai Trial Site #26

Osaka, , Japan

Eisai Trial Site #3

Saitama, , Japan

Eisai Trial Site #5

Saitama, , Japan

Eisai Trial Site #1

Shizuoka, , Japan

Eisai Trial Site #22

Tochigi, , Japan

Eisai Trial Site #28

Tokushima, , Japan

Eisai Trial Site #20

Tokyo, , Japan

Eisai Trial Site #23

Tokyo, , Japan

Eisai Trial Site #31

Tokyo, , Japan

Eisai Trial Site #13

Yamagata, , Japan

Eisai Trial Site #17

Yamaguchi, , Japan

Eisai Trial Site #32

Yamaguchi, , Japan

Eisai Trial Site #38

Gyeonggi-do, , South Korea

Eisai Trial Site #36

Incheon, , South Korea

Eisai Trial Site # 2

Seoul, , South Korea

Eisai Trial Site #33

Seoul, , South Korea

Eisai Trial Site #34

Seoul, , South Korea

Eisai Trial Site #35

Seoul, , South Korea

Eisai Trial Site #37

Seoul, , South Korea

Countries

Japan; South Korea

References

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.

Reference Type: DERIVED

PMID: 34657389 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

E2007-J000-342

Identifier Type: -

Identifier Source: org_study_id