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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)

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ClinicalTrials.gov Identifier: NCT03201900
Recruitment Status : Active, not recruiting
First Posted : June 28, 2017
Last Update Posted : June 20, 2019
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
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 1, 2017
Actual Primary Completion Date : January 28, 2019
Estimated Study Completion Date : March 31, 2021

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. The seizure-free rate during 26-week Maintenance Period for participants with partial onset seizures (POS) [ Time Frame: up to 26 weeks ]
    A seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS affects only a part of the brain. The outward effect can vary from change in emotions or feelings (simple partial seizure) to loss of awareness and consciousness (complex partial seizure). The percentage of participants with POS who achieved a seizure-free status during the 26-week Maintenance Period of 4 milligrams (mg) will be calculated. For participants for which the perampanel dose is increased from 4 mg to 8 mg, the seizure-free rate of the 26-week Maintenance Period of 8 mg will be evaluated to calculate the percentage of participants who achieved a seizure-free status regardless of perampanel dose.


Secondary Outcome Measures :
  1. The seizure free rate during 52 weeks of treatment (ie, 26-week Maintenance Period plus 26-week Extension Phase) for participants with POS [ Time Frame: up to 52 weeks ]
    A seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS affects only a part of the brain. The outward effect can vary from change in emotions or feelings (simple partial seizure) to loss of awareness and consciousness (complex partial seizure). The percentage of participants with POS who achieved a seizure-free status during 52 weeks of treatment (ie, 26-week Maintenance Period plus 26-week Extension Phase) will be calculated.

  2. Time to first seizure onset and time to withdrawal from the study from the first date of the Maintenance Period [ Time Frame: From the start of the Maintenance Period (Week 6) up to 52 weeks ]
    A seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. Median time to first seizure onset will be estimated by Kaplan-Meier method. Median time to withdraw from the study will be estimated by Kaplan-Meier method.

  3. Number of participants with any treatment-emergent (TE) serious adverse event (SAE) resulting in discontinuation of perampanel [ Time Frame: up to 52 weeks ]
    An SAE is any untoward medical occurrence that at any dose: results in death; is life threatening (ie, the participant was at immediate risk of death from the adverse events [AE] as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.

  4. Number of participants with any treatment-emergent adverse event (TEAE) resulting in discontinuation of perampanel [ Time Frame: up to 52 weeks ]
    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.



Information from the National Library of Medicine

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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.

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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT03201900     History of Changes
Other Study ID Numbers: E2007-J000-342
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: February 2019

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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
Signs and Symptoms