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    Summary
    EudraCT Number:2010-018518-56
    Sponsor's Protocol Code Number:E2007-G000-235
    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:2010-07-16
    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 number2010-018518-56
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics When Administered as an Adjunctive Therapy in Adolescents (12 to less than 18 years of age) With Inadequately Controlled Partial-onset Seizures
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study on the safety and effectivenes of study drug in reducing the number of seizures in subjects with epilepsy. The drug will be studied in young people aged from 12 to less than 18 years. It will assess if the drug has any effect on the ability to know, learn, perceive, recognize, remember, think and understand. Also, if it has effects on growth and development.
    A.4.1Sponsor's protocol code numberE2007-G000-235
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/161/2013
    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 Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEisai Limited
    B.5.2Functional name of contact pointCarol Shaw
    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 number447884436749
    B.5.5Fax number44845676 1504
    B.5.6E-mailCarol_Shaw@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, MARS
    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.3.9.2Current sponsor codeE2007
    D.3.9.3Other descriptive nameMARS
    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.3.9.2Current sponsor codeE2007
    D.3.9.3Other descriptive nameMARS
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Inadequately controlled partial onset seizures
    E.1.1.1Medical condition in easily understood language
    Control of abnormal brain activity that can cause uncontrollable movements
    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
    To compare the short-term effect of perampanel on cognition to placebo by using the Cognitive Drug Research (CDR) System when administered as an adjunctive therapy in adolescents (12 to less than 18 years of age) with inadequately controlled partial-onset seizures (with or without secondarily generalized seizures)
    E.2.2Secondary objectives of the trial
    - To assess the short-term effect of perampanel in adolescents on each of the CDR System 5 core cognitive domains of: Power of Attention, Continuity of Attention, Quality of Episodic Memory, Quality of Working Memory, and Speed of Memory
    To evaluate
    - the short- and long-term safety and tolerability of perampanel
    - the long-term effect of perampanel in adolescents on cognition by using the CDR System
    - the short- and long-term effects of perampanel on language by using the Controlled Oral Word Association Test
    - the short- and long-term effects of perampanel on visuomotor skills by using the Lafayette Grooved Pegboard Test
    - the long-term effect of perampanel on growth and development, including sexual development using Tanner Staging
    - the pharmacokinetics of perampanel using a population PK approach and to explore the PK/pharmacodynamic relationship
    - the efficacy of perampanel as determined by percent (%) change in seizure frequency and responder rate
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Core Study:
    - Considered reliable and willing to be available for the study duration and is able to record seizures and report adverse events (AEs) themselves or have a legal guardian or a caregiver who can record seizures and report AEs for them
    - Understand the requirements of the CDR System tests and able to perform the tests appropriately at Visit 1
    - Male or female, 12 to less than 18 years of age at the time of consent/assent
    - Have a diagnosis of epilepsy with partial-onset seizures with or without secondarily generalized seizures 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 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)
    - Have had a brain imaging (eg, magnetic resonance imaging [MRI] scan or computed tomography[CT]) within the 5 years prior to Visit 1 that ruled out a progressive cause of epilepsy
    - Must have had at least 1 partial-onset seizure during the 4 weeks prior to Visit 1 despite a stable regimen of 1 to 3 concomitant AEDs
    - Are currently being treated with stable doses of 1-3 AEDs. Only 1 inducer AED (either carbamazepine or phenytoin) out of the maximum of 3 AEDs is allowed
    - Are on a stable dose of the same concomitant AED(s) for at least 4 weeks prior to 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
    - Female subjects of childbearing potential must have a negative serum human chorionic gonadotropin (β-hCG) at Visit 1 and a negative urine pregnancy test prior to randomization at Visit 2. Female subjects of childbearing potential must agree for the duration of the study and for a period of at least 60 days following administration of the last dose of study medication to commit to the consistent and correct use of a medically acceptable method of birth control (eg, a double-barrier method [condom + spermicide, condom + diaphragm with spermicide]). Abstinence will be considered an acceptable method of contraception on a case by case basis upon prior approval by the Medical Monitor
    - Have an intelligence quotient (IQ) of ≥70, using the Kaufman Brief Intelligence Test, second edition (KBIT-2)
    Extension Phase:
    - Have completed all scheduled visits up to and including Visit 8 in the Core Study Randomization Phase
    E.4Principal exclusion criteria
    Core Study
    - With a diagnosis of primary generalized epilepsies or seizures such as absences and/or myoclonic epilepsies
    - Have current or a history of pseudo-seizures (psychogenic non-epileptic seizures [PNES]) within approximately 5 years prior to Visit 1
    - Have a diagnosis of Lennox-Gastaut syndrome
    - Have seizure clusters where individual seizures cannot be counted
    - Have a history of status epilepticus that required hospitalization during the 12 months prior to the Visit 1
    - Have an unstable psychiatric diagnosis that may confound the investigator’s ability to conduct the study or that may prevent completion of the protocol specified tests (eg, significant suicide risk, including suicidal behavior and ideation 6 months prior to Visit 1, current psychotic disorder, or acute mania)
    - Have any concomitant illnesses/co-morbidities (eg, autism, attention-deficit hyperactivity disorder [ADHD]) at Visit 1 that could severely affect cognitive function during the course of the study
    - Have previously participated in a clinical trial involving perampanel
    - Have chronically or routinely use benzodiazepines and who have not discontinued use at least 4 weeks prior to Visit 1
    Extension phase
    - Those who, for any reason, discontinued early from the preceding double-blind study
    E.5 End points
    E.5.1Primary end point(s)
    Primary Safety Analysis - Cognitive Function:
    Change from baseline in the CDR System Global Cognition Score will be summarized by visit during the Randomization Phase and Extension Phase Part A.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint of change from baseline in the CDR System Global Cognition Score at Week 19 will be analyzed using analysis of covariance (ANCOVA) with baseline (Visit 2) as a covariate, and region, gender and treatment as factors in the Full Analysis Set for cognition. If the Week 19 score is missing for a subject, the last non-missing score will be used in lieu of the Week 19 score for that subject. A 95% 2-sided confidence interval (CI) will be created for the difference between the perampanel and placebo groups.
    Change from the randomized baseline to the last visit (LOCF) of the Extension Phase Part A will be summarized.
    E.5.2Secondary end point(s)
    To assess the short-term effect of perampanel in adolescents on each of the CDR System 5 core cognitive domains of: Power of Attention, Continuity of Attention, Quality of Episodic Memory, Quality of Working Memory,
    and Speed of Memory.
    - To evaluate the short- and long-term safety and tolerability of perampanel in adolescents
    - To evaluate the long-term effect of perampanel in adolescents on cognition by using the CDR System
    - To evaluate the short- and long-term effects of perampanel in adolescents on language by using the Controlled Oral Word Association (COWAT)
    - To evaluate the short- and long-term effects of perampanel in adolescents on visuomotor skills by using the Lafayette Grooved Pegboard Test
    - To evaluate the long-term effect of perampanel on growth and development in adolescents, including sexual development using Tanner Staging
    - To evaluate the pharmacokinetics (PK) of perampanel in adolescents using a population PK approach and to explore the PK/pharmacodynamic (PD) relationship
    - To evaluate the efficacy of perampanel in adolescents as determined by percent (%) change in seizure frequency and responder rate
    E.5.2.1Timepoint(s) of evaluation of this end point
    See protocol section 8.5.2.2
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Double-blind with open label extensions
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Australia
    Belgium
    Czech Republic
    Hungary
    India
    Korea, Republic of
    Latvia
    Poland
    Spain
    Thailand
    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 patient last visit but for subjects who roll over into the Extension Phases, the last visit of the Maintenance Period of Core Study will be the first visit of the Extension Phase.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 132
    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: 132
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 132
    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)
    The investigator will provide the appropriate medical treatment and other necessary
    measures as needed.
    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 Decision2010-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-01
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