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    Summary
    EudraCT Number:2017-001180-20
    Sponsor's Protocol Code Number:E2007-G000-410
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2021-10-28
    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 number2017-001180-20
    A.3Full title of the trial
    Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Add-on Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures
    A.4.1Sponsor's protocol code numberE2007-G000-410
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03288129
    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 Inc.
    B.1.3.4CountryUnited States
    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 Inc.
    B.5.2Functional name of contact pointEisai Medical Information
    B.5.3 Address:
    B.5.3.1Street Address100 Tice Boulevard Woodcliff Lake
    B.5.3.2Town/ cityNew Jersey
    B.5.3.3Post code07677
    B.5.3.4CountryUnited States
    B.5.4Telephone number1888-274-2378
    B.5.6E-mailesi_medinfo@eisai.com
    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, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.8 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 number4
    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 number6
    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 number8
    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 number10
    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 number12
    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:
    Partial Onset Seizures with or without
    1) Secondarily Generalized Seizures
    2) Primary Generalized Tonic-Clonic Seizures
    E.1.1.1Medical condition in easily understood language
    One part of brain affected called partial seizure. Partial seizures, encompass entire brain called generalized seizure. Disturbance in functioning of both sides of brain called Tonic-Clonic Seizures.
    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 24.0
    E.1.2Level PT
    E.1.2Classification code 10085326
    E.1.2Term Parietal lobe 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 assess the retention rate of perampanel when given as monotherapy or 1st adjunctive therapy in subjects with partial-onset seizures (POS) or primary generalized tonic-clonic seizures (PGTCS)
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of perampanel when given as monotherapy or 1st adjunctive therapy in subjects with POS or PGTCS as measured by seizure freedom; to assess the proportion of subjects with POS or PGTCS that are able to convert from 1st adjunctive therapy to perampanel monotherapy; to assess the safety of perampanel as initial monotherapy or 1st adjunctive therapy in subjects with POS or PGTCS; to assess dosing and titration of perampanel when administered as initial monotherapy or 1st adjunctive therapy in subjects with POS or PGTCS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects will be male or female and no younger than 4 years of age and be able to swallow perampanel tablets.
    2. Subjects must have a diagnosis of epilepsy with POS with or without secondarily generalized seizures (SGS) or with primary generalized tonic-clonic seizures (PGTCS). Either of the following must have occurred to support an epilepsy diagnosis:
    a. At least two unprovoked (or reflex) seizures occurring greater than 24 hours apart
    b. One unprovoked (or reflex) seizure with electroencephalography (EEG) evidence of seizures
    3. Subjects who receive perampanel as a first adjunctive therapy must currently have been treated with stable doses of monotherapy with an anti-epileptic drug (AED) for 8 weeks prior to Visit 2 (Week 0), have not previously received adjunctive AED treatment, and must, in the investigator's judgement, be in need of initial adjunctive therapy after failure to control seizures with AED monotherapy, at the optimal dose and duration.
    4. Subjects who receive perampanel as monotherapy, who were newly diagnosed (treatment naïve), following the defined diagnosis of epilepsy.
    5. Subjects who are currently receiving monotherapy treatment may receive perampanel as monotherapy if, in the investigator's judgment, the participant may benefit from a change in monotherapy treatment. Subjects must not have previously received adjunctive AED treatment.
    6. If antidepressants or antianxiety drugs are used, subjects must be on a stable dose regimen of these drugs during the 8 weeks before Visit 2 (Week 0).
    E.4Principal exclusion criteria
    1.Subjects should not have previously received or currently be receiving perampanel.
    2.Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta human chorionic gonadotropin [β-hCG] or hCG test with a minimum sensitivity of 25 International Units per liter [IU/L] or equivalent units of β-hCG or hCG); a separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
    3.Females of childbearing potential who:
    •Within 28 days before study entry, 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
    •An oral contraceptive (with additional barrier method if using contraceptive containing levonorgestrel);
    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
    -For sites outside of the European Union, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the subject, then the subject must agree to use a medically acceptable method of contraception, i.e, double barrier methods of contraception such as condom plus diaphragm or cervical/vault cap with spermicide.
    NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
    4.Presence of or previous history of Lennox-Gastaut syndrome
    5.Presence of non-motor simple partial seizures only
    6.A history of status epilepticus within 1 year before Screening Visit (Visit 1)
    7.Subjects on antipsychotics or who have psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of attempted suicide within 1 year before Screening Visit (Visit 1)
    8.Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
    9.Concomitant use of barbiturates (except for seizure control indication and premedication for electroencephalogram) and benzodiazepines (except for seizure control indication) within 8 weeks prior to Visit 2 (Week 0)
    10.Use of intermittent rescue benzodiazepines (i.e, 1 to 2 doses over a 24-hour period is considered a one time rescue) 2 or more times in the 8-week period prior to Visit 2 (Week 0)
    11.Severe renal insufficiency (defined by estimated glomerular filtration rate of < 30 milliliters per minute [mL/min]) or subjects who receive hemodialysis
    12.Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the subject’s safety or study conduct NOTE: Stable elevation of liver enzymes, alanine aminotransferase and aspartate aminotransferase due to concomitant medication(s) will be allowed if they are less than 3 times the upper limits of normal. 13.Hypersensitivity to perampanel or any excipients
    14.Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
    15.Subjects who are participating in other interventional clinical trial
    16.Subject who are judged to have inadequate cognitive ability for participation in the study (intelligence quotient < 80 or investigator judgment)
    17.Any suicidal ideation with intent with or without a plan, at the time of or within 6 months of screening, as indicated by answering "Yes" to questions 4 and 5 on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS)
    18.Any lifetime suicidal behavior based on the C-SSRS
    19.Concomitant use of any form of cannabidiol (CBD)
    20.Planned brain surgery during study participation
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of subjects remaining on perampanel at 3 months after the initiation of treatment (retention rate) 2. Percentage of subjects remaining on perampanel at 6 months after the initiation of treatment (retention rate) 3. Percentage of subjects remaining on perampanel at 9 months after the initiation of treatment (retention rate) 4. Percentage of subjects remaining on perampanel at 12 months after the initiation of treatment (retention rate)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Month 3
    2. Month 6
    3. Month 9
    4. Month 12
    E.5.2Secondary end point(s)
    1. Percentage of subjects who achieve seizure-free status for partial-onset seizures (POS), secondarily generalized seizures (SGS), and primary generalized tonic-clonic seizures (PGTCS) during the Maintenance Period
    2. Percentage of subjects who achieve 3-month seizure-free status for POS, SGS, and PGTCS
    3. Percentage of subjects who achieve 6-month seizure-free status for POS, SGS, and PGTCS
    4. Percentage of subjects who receive perampanel as a first adjunctive therapy who are able to convert to perampanel monotherapy
    5. Number of subjects with any treatment-emergent adverse event (AE)
    6. Number of subjects with any treatment-emergent serious adverse event (SAE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to 39 weeks
    2. Up to Month 3
    3. Up to Month 6
    4. Up to 39 weeks
    5. Up to approximately 24 months
    6. Up to approximately 24 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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 Last Subject (LVLS) is when the final subject was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months44
    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: 4
    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: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 54
    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: United States
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