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    Summary
    EudraCT Number:2014-002167-16
    Sponsor's Protocol Code Number:E2007-G000-311
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-06-12
    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 number2014-002167-16
    A.3Full title of the trial
    An Open-Label, Multicenter Study with an Extension Phase to Evaluate the Safety, Tolerability, and Exposure-Efficacy Relationship of Perampanel Oral Suspension when Administered as an Adjunctive Therapy in Pediatric Subjects (Age 4 to less than 12 years) with Inadequately Controlled Partial-Onset Seizures or Primary Generalized Tonic-Clonic Seizures
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study being done to see if the Study Drug is safe, tolerable, and can help control seizure in children with epilepsy who are aged 4 to less than 12 years of age and who are already taking seizure medications. The study will also look at pharmacokinetics, which is used to find out the concentration of perampanel in your child's blood over a period of time
    A.4.1Sponsor's protocol code numberE2007-G000-311
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02849626
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/118/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEisai Limited
    B.1.3.4CountryUnited Kingdom
    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 Europe Ltd
    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 Oral suspension
    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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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)
    2) Primary Generalized Tonic-Clonic Seizures (PGTC)
    E.1.1.1Medical condition in easily understood language
    1) Fits that affect one part of your brain called a “partial seizure”
    2) Certain fits that affect all of your brain from the start called “generalised seizures" and cause convulsions/staring spells
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10018101
    E.1.2Term Generalised tonic-clonic seizures
    E.1.2System Organ Class 100000004852
    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 safety and tolerability of perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to <12 years) with inadequately controlled POS or PGTC
    E.2.2Secondary objectives of the trial
    To characterize PK of perampanel and relationship between perampanel plasma concentrations, efficacy and safety using population PK/PD modeling; evaluate effects of perampanel on cognition, behavior, visuomotor skills and growth & development in children during short-term (23 weeks) & long-term (up to 52 weeks) treatment; evaluate frequency of EEG abnormalities during awake & sleep state during 52 weeks of treatment; evaluate suicidal ideation and behavior in children 6 to <12 years as measured by C-SSRS during 52 weeks of treatment; evaluate efficacy of perampanel as measured by median percent change per 28 days in seizure frequency by proportion of responders (>=25%, >=50% and >=75%) and by proportion of subjects who are seizure-free for POS, PGTC, & GTC seizures; evaluate, in Japanese subjects, efficacy of perampanel on POS in this study compared to Placebo in Study E2007-J000-335; assess effects of perampanel on Clinical Global Impression (CGI), as measured by CGI of change (CGIC)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have a diagnosis of epilepsy with POS with or without secondarily generalized seizures or PGTC according to the International League Against Epilepsy’s (ILAE) Classification of Epileptic Seizures (1981). Diagnosis should have been established at least 6 months prior to Visit 1 by clinical history and an electroencephalography (EEG) that is consistent with the diagnosis; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history)
    2. Male or female subject, from age 4 to <12 years at the time of informed consent/assent.
    3. Have a minimum weight of 16 kilogram (kg) (35 pound [lb])
    4. Have had a brain imaging (e.g., magnetic resonance imaging [MRI) scan or computed tomography [CT]) before Visit 1 that ruled out a progressive cause of epilepsy
    5. During the 12 weeks +-3 days (4 weeks +-3 days in Japan only) before Visit 2, subjects must have had equal or greater than (>=) 1 POS or 1 PGTC seizure. Only simple POS with motor signs, complex POS, and complex POS with secondary generalization are counted toward this inclusion for POS
    6. Are currently being treated with stable doses of 1 to a maximum of 3 approved antiepileptic drug (AEDs) Doses must be stable for at least 4 weeks before Visit 1; in the case where a new AED regimen has been initiated for a subject, the dose must be stable for at least 8 weeks prior to Visit 1. Only 1 enzyme inducing antiepileptic drug (EIAED) (defined as carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of 3 AEDs is allowed (A vagal nerve stimulator [VNS] will be counted as one of the 3 allowed AEDs)
    E.4Principal exclusion criteria
    1. Females who are breastfeeding/pregnant at Screening/Baseline. A separate baseline assessment required if a negative screening pregnancy test was obtained >72 hours before 1st dose of study drug
    2. Females of childbearing potential who:
    o Had unprotected sexual intercourse within 30 days before study entry & who do not agree to use a highly effective method of contraception in the study period or for 28 days after study drug discontinuation. If a highly effective method is not appropriate or acceptable for subject, then subject may use a medically effective method.
    o Are currently abstinent, and do not agree to use a double-barrier method or refrain from sexually active during study period or for 28 days after study drug discontinuation
    o Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing & who do not agree to use same contraceptive during the study or for 28 days after study drug discontinuation
    3. Current or history of pseudo-seizures within approximately 5 years before Visit 1
    4. History of status epilepticus that required hospitalization during 6 months before Visit 1
    5. Have an unstable psychiatric diagnosis that may confound subjects’ ability to participate in the study or that may prevent completion of the protocol specified tests
    6. Any suicidal ideation with intent with or without a plan within 6 months before Visit 2 in subjects >= 6 years
    7. Are scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1; however, those who have previously documented “failed” epilepsy surgery will be allowed
    8. Evidence of clinically significant disease (e.g. cardiac, respiratory, gastrointestinal, renal disease) that in opinion of the investigators could affect subject’s safety or interfere with the study assessments
    9. Evidence of moderate or severe renal insufficiency
    10. Evidence of significant active hepatic disease. Stable elevation of liver enzymes, ALT and AST due to concomitant medication(s), will be allowed if they are less than 3 times the ULN
    11. Evidence of significant active hematological disease
    12. Clinically significant ECG abnormality, including prolonged corrected QT interval
    13. Have a progressive central nervous system disease, including degenerative CNS diseases and progressive tumors
    14. Multiple drug allergies or a severe drug reaction to an AED, including dermatological, hematological,or organ toxicity
    15. Concomitant use of felbamate as an AED for <2 years or where the dose has not been stable for at least 8 weeks before Visit 1. If subjects received felbamate in past, it must have been discontinued 8 weeks before Visit 1
    16. Concomitant use of vigabatrin: Subjects who took vigabatrin in past must be off vigabatrin for at least 5 months before Visit 1 & with documentation showing no evidence of a vigabatrin associated clinically significant abnormality in a visual perimetry test
    17. Concomitant use of cannabinoids
    18. Used benzodiazepines for epilepsy during which dose has not been stable for >4 weeks prior to Visit 1 Benzodiazepines use as rescue medication for seizure control is allowed; however, intermittent use of benzodiazepines for any other indication is prohibited
    19. A VNS implanted <5 months before Visit 1 or changes in parameter <4 weeks before Visit 1 (or thereafter during study)
    20. On a ketogenic diet for which diet is not stable regimen for at least 4 weeks before Visit 1
    21. History of or a concomitant medical condition that in opinion of investigator(s) would preclude subject's participation in a clinical study or compromise the subject's ability to safely complete study
    22. Have previously been exposed to perampanel in a clinical trial or by prescription for >2 months or discontinued for AEs
    23. 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
    24. With rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability, which include incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), laboratory parameters, vital signs, and electrocardiogram (ECG) parameters, of perampanel oral suspension in children (ages 4 to <7 years and >=7 years to <12 years) with POS or PGTC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the core phase and the extension phase
    E.5.2Secondary end point(s)
    1. The relationship between plasma levels of perampanel and efficacy endpoints (that is, change in average seizure frequency over 28 days, responder probability, and the proportion of subjects who are seizure-free in the Maintenance Period of the Core Study) separately for each seizure type
    2. The relationship between plasma levels of perampanel and cognition endpoints including change from baseline in A-B neuropsycological assessment schedule (ABNAS), Child Behavior Checklist (CBCL), and Lafayette Grooved Pegboard Test (LGPT). In addition, depending on the AE data, the relationship between plasma levels of perampanel and select AEs will be assessed
    3. Change from baseline at Week 23 and Week 52 in ABNAS, CBCL, and LGPT
    4. Changes from baseline at Week 23 and Week 52 in growth and development parameters (height, weight, thyroid, and insulin like growth factor-1 [IGF-1])
    5. Change from baseline in Electroencephalography (EEG) and the frequency of EEG abnormalities during awake and sleep state
    6. Proportion of subjects (aged 6 or older at time of consent/assent) with any treatment-emergent reports of suicidal ideation and behavior on the C-SSRS and intensity of these behaviors assessed using C-SSRS scores
    7. The median percent change in seizure frequency per 28 days during Treatment Phase (Titration Period and Maintenance Period) of the Core Study, and during the long-term treatment (up to 52 weeks) relative to the Pretreatment Phase. Seizure frequency will be based on the number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28
    8. Proportion of responders (25 percent [%] responders defined as a decrease in 28-day seizure frequency of equal or >25% compared to baseline seizure frequency; 50% responders defined as a decrease in 28-day seizure frequency of >=50% compared to baseline seizure frequency; 75% responders defined as a decrease in 28-day seizure frequency of >=75% compared to baseline seizure frequency) during Maintenance Period of Core Study, and during the long term treatment (up to 52 weeks)
    9. Proportion of subjects who are seizure-free during Maintenance Period of Core Study, and during the long term treatment (up to 52 weeks)
    10. CGI of change
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the core phase and the extension phase
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Exposure-Efficacy relationship
    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 trial2
    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
    Canada
    Japan
    Korea, Republic of
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years2
    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: 180
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 180
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects are children aged between 4 to <12 years of age at study enrolment.
    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 160
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Perene Network
    G.4.3.4Network Country France
    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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