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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201900
Recruitment Status : Active, not recruiting
First Posted : June 28, 2017
Results First Posted : February 25, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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).

Condition or disease Intervention/treatment Phase
Partial Onset Seizures Drug: E2007 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : June 28, 2017
Actual Primary Completion Date : February 28, 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Perampanel

Arm Intervention/treatment
Experimental: 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.
Drug: E2007
Oral tablet
Other Names:
  • Perampanel
  • Fycompa
  • 2-(2-Oxo-1-phenyl-5-pyridin-2-yl-1,2-dihydropyridin-3-yl) benzonitrile hydrate (4:3)




Primary Outcome Measures :
  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: up to 26 weeks in 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.


Secondary Outcome Measures :
  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 [ Time Frame: up to 26 weeks in 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 26-week Maintenance Period of last evaluated dose of 4 or 8 mg perampanel.

  2. Percentage of Participants With POS Who Achieved Seizure-free Status During 52-weeks of Treatment (26-week Maintenance Period Plus 26-weeks of 124 Week's Extension Phase) of 4 mg of Perampanel [ Time Frame: up to 52 weeks (Maintenance Period of 4 mg perampanel + Extension Phase 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 52-weeks Treatment of 4 mg perampanel. Data for this outcome measure will be reported after study completion (which is planned for 2020).

  3. Percentage of Participants With POS Who Achieved Seizure-free Status During 52-weeks of Treatment (26-week Maintenance Period Plus 26-weeks of 124 Week's Extension Phase) of Last Evaluated Dose of 4 or 8 mg Perampanel [ Time Frame: up to 52 weeks (Maintenance Period of last evaluated dose of 4 or 8 mg perampanel + Extension Phase 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 52-weeks Treatment of last evaluated dose of 4 or 8 mg perampanel. Data for this outcome measure will be reported after study completion (which is planned for 2020).

  4. Time to Onset of First Seizure From Study From the First Date of the Maintenance Period of 4 mg Perampanel [ Time Frame: From the first date of the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks) ]
    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. Data for this outcome measure will be reported after study completion (which is planned for 2020).

  5. Time to First Seizure Onset From Study From the First Date of the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel [ Time Frame: From the first date of the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks) ]
    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. Data for this outcome measure will be reported after study completion (which is planned for 2020).

  6. Time to Withdrawal From Study From the First Date of the Maintenance Period of 4 mg Perampanel [ Time Frame: From the first date of the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks) ]
    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. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. Data for this outcome measure will be reported after study completion (which is planned for 2020).

  7. Time to Withdrawal From Study From the First Date of the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel [ Time Frame: From the first date of the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks) ]
    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. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. Data for this outcome measure will be reported after study completion (which is planned for 2020).

  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 [ Time Frame: From baseline up to 28 days after last dose of study drug (up to 160 weeks) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 74 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201900


Locations
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Japan
Eisai Trial Site #1
Shizuoka, Japan
Korea, Republic of
Eisai Trial Site # 2
Seoul, Korea, Republic of
Sponsors and Collaborators
Eisai Co., Ltd.
  Study Documents (Full-Text)

Documents provided by Eisai Inc. ( Eisai Co., Ltd. ):
Study Protocol  [PDF] October 31, 2019
Statistical Analysis Plan  [PDF] April 15, 2019

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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT03201900    
Other Study ID Numbers: E2007-J000-342
First Posted: June 28, 2017    Key Record Dates
Results First Posted: February 25, 2020
Last Update Posted: May 12, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
perampanel
Additional relevant MeSH terms:
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Seizures
Neurologic Manifestations
Nervous System Diseases