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    Summary
    EudraCT Number:2019-003734-17
    Sponsor's Protocol Code Number:E2007-J000-342
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-11-22
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2019-003734-17
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Patients with Partial Onset Seizures (Including Secondarily Generalized Seizures)
    A.4.1Sponsor's protocol code numberE2007-J000-342
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEisai Co., Ltd. (Japan)
    B.1.3.4CountryJapan
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEisai Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEisai Europe Ltd.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressEuropean Knowledge Centre, Mosquito Way
    B.5.3.2Town/ cityHatfield, Hertfordshire
    B.5.3.3Post codeAL10 9SN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442086001400
    B.5.5Fax number442086001388
    B.5.6E-mailEUMedInfo@Eisai.net
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fycompa
    D.2.1.1.2Name of the Marketing Authorisation holderEisai GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePerampanel
    D.3.2Product code E2007
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPerampanel
    D.3.9.1CAS number 380917-97-5
    D.3.9.2Current sponsor codeE2007
    D.3.9.3Other descriptive namePERAMPANEL
    D.3.9.4EV Substance CodeSUB32160
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Epilepsy : 1) Partial-Onset Seizures (POS)
    E.1.1.1Medical condition in easily understood language
    1) Epilepsy: Seizures that affect one part of your brain called a "partial seizure"
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10015037
    E.1.2Term Epilepsy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the seizure-free rate of the 26-week Maintenance Period in untreated subjects with partial onset seizures (POS)
    E.2.2Secondary objectives of the trial
    To evaluate the seizure-free rate of the 52-week treatment in untreated subjects with POS; confirm time to first seizure onset and time to withdrawal from the study from the first date of the Maintenance Period in untreated subjects with POS; evaluate the safety and tolerability of perampanel monotherapy in untreated subjects with POS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 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
    2. Subjects 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
    3. Subjects who have excluded the progressive central nervous system (CNS) abnormality occurring seizures by computed tomography (CT) or magnetic resonance imaging (MRI)
    4. Subjects 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 subject meets the other diagnosis criterion (ie, clinical history).
    E.4Principal exclusion criteria
    1. Subjects who present only simple partial seizures without motor signs
    2. Subjects who have seizure clusters where individual seizures cannot be counted
    3. Subjects who present or have a history of Lennox-Gastaut syndrome
    4. Subjects who have a history of status epilepticus
    5. Subjects who have a history of psychogenic non-epileptic seizures
    6. Subjects who have a history of suicidal ideation/attempt
    7. Subjects who present clinically problematic psychological or neurological disorder(s)
    8. Evidence of clinically significant disease
    9. Evidence of clinically significant active hepatic disease
    10. A prolonged time from the beginning of the QRS complex to the end of the T wave (QT) interval corrected for heart rate
    11. Subjects 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
    12. Subjects who have not used a stable dose of antidepressant in the 12 weeks
    13. Subjects who have a history of any type of surgery for brain or central nervous system within 1 year
    14. Subjects who have a history of receiving any AED (including AED used as rescue treatment) for more than 2 weeks
    15. Subjects who have used intermittent rescue benzodiazepines on 2 or more occasions within 4 weeks
    16. Subjects who have a history of receiving any AED polytherapy
    17. Subjects who experienced treatment with perampanel
    18. Subjects who have had non-constant ketogenic diet within 4 weeks
    19. Subjects who have a history of drug or alcohol dependency or abuse
    20. Subjects who have had multiple drug allergies or a severe drug reaction to an AED(s)
    21. Females who are breastfeeding or pregnant in the Pretreatment Phase (as documented by a positive beta-human chorionic gonadotropin [β-hCG] test)
    22. 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) (Subject 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
    23. Subjects 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.
    E.5 End points
    E.5.1Primary end point(s)
    The seizure free rate in the 26-week Maintenance Period for subjects with POS
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to Week 26
    E.5.2Secondary end point(s)
    1. The seizure free rate in the 52-week treatment (ie, 26-week Maintenance Period plus 26- week Extension Phase) for subjects with POS
    2. Time to first seizure onset and time to withdrawal from the study from the first date of the Maintenance Period
    3. The safety and tolerability of perampanel
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to Week 52
    2. From the start of the Maintenance Period (Week 6) up to the occurrence of first seizure onset during the study period or discontinuation from study (approximately up to Week 52)
    3. Up to Week 26 and end of study (approximately up to Week 52)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Japan
    Korea, Republic of
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last subject (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 7
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 7
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 71
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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