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    Summary
    EudraCT Number:2013-005391-17
    Sponsor's Protocol Code Number:E2007-G000-238
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-25
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedLatvia - SAM
    A.2EudraCT number2013-005391-17
    A.3Full title of the trial
    An Open-Label Study With an Extension Phase to Evaluate the
    Pharmacokinetics of Perampanel (E2007) Oral Suspension When Given as an Adjunctive Therapy in Subjects From 1 Month to Less Than 4 years of Age With Epilepsy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study done to determine the concentration of the investigational drug, perampanel (E2007) (called, "Study Drug") in the child's blood over a period of time.
    A.4.1Sponsor's protocol code numberE2007-G000-238
    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
    B.5.3.3Post codeAL10 9SN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number44(0)208600 1400
    B.5.5Fax number44(0)8600 1388
    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 No
    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 Yes
    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 Yes
    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
    This study is to investigate the pharmacokinetics (PK) of perampanel in pediatric subjects from age ≥1 month to <4 years.
    E.1.1.1Medical condition in easily understood language
    A study done to determine the concentration of the investigational drug,
    perampanel (E2007) (called, "Study Drug") in the child's blood over a
    period of time.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the PK of perampanel during the Maintenance Period of the Core Study following oral suspension administration given as an adjunctive therapy in pediatric subjects from 1 month to less than 4 years of age with epilepsy.
    E.2.2Secondary objectives of the trial
    - To evaluate the short- and long-term safety and tolerability of perampanel oral suspension given as an adjunctive therapy in subjects from 1 month to less than 4 years of age with epilepsy
    - To evaluate the long-term effect of perampanel oral suspension, given as an adjunctive therapy, on growth from baseline to end of treatment in pediatric subjects from 1 month to less than 4 years of age of age with epilepsy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, from ≥1 month to < 4 years) of age (and of at least 36 weeks gestational age) at the time of consent
    2. Have a minimum weight of 4 kg (8.8 lb)
    3. Have a diagnosis of epilepsy with any type of seizure according to the ILAE guidelines: International League Against Epilepsy’s Classification of Epileptic Seizures (1981). Diagnosis should have been established at least 2 weeks (≤6 months of age) or 4 weeks (>6 months of age) before Visit 1, by clinical history and an electroencephalogram (EEG) that is consistent with epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history)
    4. Have had brain imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) before Visit 1 that ruled out a progressive cause of epilepsy
    5. Have had 1 or more seizure(s) before Visit 1
    6. Are currently being treated with a stable dose (ie, unchanged for at least 5 half-lives) of 1 to a maximum of 3 AEDs (At least 6, but not more than 8 subjects will be taking 1 EIAEDs [ie, CBZ, OXC, PHT, or ESL] out of the maximum of 3 AEDs allowed. The remaining subjects cannot be taking any EIAEDs)
    7. Have been on their current concomitant AED(s) with a stable dose for at least 2 weeks or 5 half-lives, whichever is longer, before Visit 1
    8. Must have discontinued all restricted medications at least 2 weeks or 5 half-lives (whichever is longer) before Visit 1
    E.4Principal exclusion criteria
    1. Have a history of status epilepticus that required hospitalization during the 3 months before Visit 1
    2. Have seizures due to treatable medical conditions, such as those arising due to metabolic disturbances, toxic exposure, or an active infection
    3. Have epilepsy secondary to progressive central nervous system (CNS) disease or any other progressive neurodegenerative disease, including tumors
    4. Have had epilepsy surgery within 1 year of Visit 1
    5. Are scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1
    6. Used intermittent rescue benzodiazepines (ie, 1 to 2 doses over a 24-hour period considered one-time rescue) 2 or more times in the 2 weeks before Visit 1
    7. Prior use of felbamate
    8. Prior use of vigabatrin
    9. Are on a ketogenic diet that has not been stable for at least 4 weeks before Visit 1
    10. Have used other drugs known to influence the CNS, where the dose has not been stabilized for at least 2 weeks (≤6 months of age) or 4 weeks (>6 months of age) before Visit 1
    11. Have any concomitant illnesses/co-morbidities that could severely affect the subject’s safety or study conduct
    12. Have evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the subject’s safety or study conduct
    13. Have clinically significant laboratory abnormalities or any clinically acute or chronic disease
    14. Have evidence of significant active hepatic disease. Stable elevation of liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) due to concomitant medication(s), will be allowed if they are less than 3 times the upper limits of normal (ULN)
    15. Have clinical evidence of significant active hematological disease; white blood cell (WBC) count ≤2500/μL (2.50 x 10^9/L) or an absolute neutrophil count ≤1000/μL (1.00 x 10^9/L)
    16. Have conditions that may interfere with their participation in the study and/or with the PK of study drug
    17. 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
    18. Have previously participated in a clinical trial involving perampanel
    19. Have a clinically significant electrocardiogram (ECG) abnormality, including prolonged corrected QT interval (QTc) defined as > 450 msec
    20. Have had multiple drug allergies or a severe drug reaction to an AE(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study will be a PK analysis of perampanel following oral suspension administration in pediatric subjects from 1 month to less than 4 years of age with epilepsy, using a population PK approach.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood samples (1.0 mL) for PK will be collected from all subjects for determination of perampanel concentrations during Visits 5 (Week 8), 7 (Week 14), and 8 (Week 16) for non EIAED subjects and at Visits 6 (Week 12), 8 (Week 18) and 9 (Week 20) for EIAED subjects, as well as at discontinuation.
    After every 4th subject completes the Maintenance Period where dose normalized exposure will be compared to that observed in other studies in subjects between ≥2 and <18 years of age for evidence of systematic deviations potentially warranting dose adjustment in this age group or for other subjects enrolled in the study.
    All PK data will be analyzed when all subjects have completed the Maintenance Period.
    E.5.2Secondary end point(s)
    Secondary endpoints are safety endpoints and include: frequency of treatment-emergent adverse events (TEAEs), clinical laboratory parameters, vital signs, ECG results, and growth parameters (height, weight, head circumference, thyroid function and IGF-1 parameters)
    E.5.2.1Timepoint(s) of evaluation of this end point
    All data from the Pretreatment and Treatment Phases (Core Study) will be analyzed when all subjects have completed the Maintenance Period. In addition, data from the Pretreatment, Treatment, and Extension Phases will be analyzed when all subjects have completed 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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Czechia
    Latvia
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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: 17
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 16
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 1
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects are Infants & toddlers and children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4
    F.4.2.2In the whole clinical trial 17
    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)
    Not Applicable
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-19
    P. End of Trial
    P.End of Trial StatusCompleted
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