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Partial Onset SeizuresPhase 3NCT03201900

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

A Phase 3 study testing E2007 in people with Partial Onset Seizures, run by Eisai Co., Ltd. at 38 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 12 to 74 years
Conditions the study is for
Partial Onset Seizures
What is being tested?
E2007
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
38 sitesin 2 countries
Study dates
28 Jun 2017to 27 Jul 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 74 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 30Show fewer
  • 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

Trial locations and contacts

38 sites in 2 countries.

38 sites in 2 countries

Japan31 sites

  • Eisai Trial Site #18

    Aichi

  • Eisai Trial Site #19

    Aichi

  • Eisai Trial Site #11

    Fukuoka

  • Eisai Trial Site #29

    Fukuoka

  • Eisai Trial Site #4

    Hiroshima

  • Eisai Trial Site #16

    Hokkaido

  • Eisai Trial Site #8

    Hokkaido

  • Eisai Trial Site #14

    Hyōgo

  • Eisai Trial Site #6

    Hyōgo

  • Eisai Trial Site #7

    Kagoshima

  • Eisai Trial Site #9

    Kanagawa

  • Eisai Trial Site #10

    Kyoto

  • Eisai Trial Site #30

    Miyagi

  • Eisai Trial Site #25

    Nagasaki

  • Eisai Trial Site #27

    Nagasaki

  • Eisai Trial Site #15

    Nara

  • Eisai Trial Site #12

    Niigata

  • Eisai Trial Site #21

    Osaka

  • Eisai Trial Site #24

    Osaka

  • Eisai Trial Site #26

    Osaka

  • Eisai Trial Site #3

    Saitama

  • Eisai Trial Site #5

    Saitama

  • Eisai Trial Site #1

    Shizuoka

  • Eisai Trial Site #22

    Tochigi

  • Eisai Trial Site #28

    Tokushima

  • Eisai Trial Site #20

    Tokyo

  • Eisai Trial Site #23

    Tokyo

  • Eisai Trial Site #31

    Tokyo

  • Eisai Trial Site #13

    Yamagata

  • Eisai Trial Site #17

    Yamaguchi

  • Eisai Trial Site #32

    Yamaguchi

Other trials in Japan

South Korea7 sites

  • Eisai Trial Site #38

    Gyeonggi-do

  • Eisai Trial Site #36

    Incheon

  • Eisai Trial Site # 2

    Seoul

  • Eisai Trial Site #33

    Seoul

  • Eisai Trial Site #34

    Seoul

  • Eisai Trial Site #35

    Seoul

  • Eisai Trial Site #37

    Seoul

Other trials in South Korea

About this study

Official title: 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)

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

Being tested
E2007
Keywords
perampanel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E2007Drug

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

    Oral tablet

Study groups in NCT03201900
Study groupRoleWhat they receive
E2007ExperimentalThe 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.
Receives: Drug: E2007

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 26 weeks in Maintenance Period of 4 mg perampanel

Secondary outcomes (8)

  1. 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

    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 the 26-week Maintenance Period of last evaluated dose of 4 or 8 mg perampanel.

    Measured: 26 weeks in Maintenance Period of 4 or 8 mg perampanel

  2. 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

    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 52-weeks treatment of 4 mg perampanel.

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

  3. 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

    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 the 52-week treatment of last evaluated dose of 4 or 8 mg perampanel.

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

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

    Time to onset of first seizure was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the onset of first seizure. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain.

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

  5. 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

    Time to onset of first seizure was defined as the period from the first dose of study drug in the 4 mg or 8 mg Maintenance Period to the onset of first seizure. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain.

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

  6. Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of 4 mg Perampanel

    Time to withdrawal from the study was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the date of withdrawal from study, regardless of reason.

    Measured: From the first dose of study drug in the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks)

  7. Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel

    Time to withdrawal from the study was defined as the period from the first dose of study drug in the 4 mg or 8 mg Maintenance Period to the date of withdrawal from study, regardless of reason.

    Measured: From the first dose of study drug in the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks)

  8. Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Event (TESAEs), and TEAEs Leading to Discontinuation of the Study Drug

    Measured: From baseline up to 28 days after last dose of study drug (up to 160 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2017
  2. Study start28 Jun 2017
  3. Primary completion28 Feb 2019
  4. Study completion27 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03201900
Sponsor's protocol ID
E2007-J000-342
Status last verified
Feb 2020
First submitted
27 Jun 2017
Last updated
5 Aug 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 34657389

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing E2007 in people with Partial Onset Seizures, run by Eisai Co., Ltd. at 38 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03201900, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.

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