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    Summary
    EudraCT Number:2007-006169-33
    Sponsor's Protocol Code Number:E2007-G000-306
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-26
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-006169-33
    A.3Full title of the trial
    A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-
    Group Study to Evaluate the Efficacy and Safety of E2007
    (perampanel) Given as Adjunctive Therapy in Subjects with
    Refractory Partial Seizures
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberE2007-G000-306
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEISAI Ltd
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeE2007
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboFilm-coated tablet
    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
    epilepsy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10065336
    E.1.2Term Partial epilepsy
    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 efficacy of 3 doses of
    perampanel (2 mg, 4 mg, and 8 mg) in comparison to placebo given as an adjunctive therapy
    in subjects with refractory partial seizures.
    E.2.2Secondary objectives of the trial
    valutare la sicurezza e la tollerabilita' di perampanel a confronto con il placebo in soggetti con epilessia parziale refrattaria.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provide written informed consent signed by the subject or legal guardian prior to entering
    the study or undergoing any study procedures (If the written informed consent is
    provided by the legal guardian because the subject is unable to do so, a written or verbal
    assent from the subject must also be obtained.);
    2. Be considered reliable and willing to be available for the study period and is able to
    record seizures and report AEs them self or have a caregiver who can record seizures and
    report AEs for them;
    3. Male or female and greater than or equal to 12 years of age (within the course of the
    study);
    4. Females should be either of non-childbearing potential (defined as having undergone
    surgical sterilization, or postmenopausal [age 50 and amenorrheic for 12 months]) or of
    childbearing potential. Females of childbearing potential must have a negative serum ßhCG
    at Visit 1 and a negative urine pregnancy test prior to randomization at Visit 2.
    Female subjects of childbearing potential must agree to be abstinent or to use at least
    1 medically acceptable methods of contraception (eg, a double-barrier method [eg,
    condom + spermicide, condom + diaphragm with spermicide], IUD, or have a
    vasectomised partner) starting at Visit 1 and throughout the entire study period and for
    2 months after the last dose of study drug. Those women using hormonal contraceptives
    must also be using an additional approved method of contraception (as described
    previously) starting at Visit 1 and continuing throughout the entire study period and for
    2 months after the last dose of study drug. (It is not required for male subjects to use
    contraceptive measures based on preclinical toxicology data provided in Section 1.3.)
    5. Have a diagnosis of epilepsy with partial seizures with or without secondarily generalized
    seizures according to the International League Against Epilepsy’s Classification of
    Epileptic Seizures (1981) (Appendix 5). Diagnosis should have been established by
    clinical history and an electroencephalogram (EEG) that is consistent with localizationrelated
    epilepsy; normal interictal EEGs will be allowed provided that the subject meets
    the other diagnosis criterion (ie, clinical history).
    6. Have had a computed tomography (CT) or magnetic resonance imaging (MRI) within the
    last 10 years that ruled out a progressive cause of epilepsy;
    perampanel Eisai Medical Research, Inc. and Eisai Limited
    Clinical Study Protocol: E2007-G000-306 12 February 2008
    Confidential Page 24 of 100
    7. Have uncontrolled partial seizures despite having been treated with at least 2 different
    AEDs within approximately the last 2 years;
    8. During the 6-week Pre-randomization Phase subjects must have had &#8805;5 partial seizures
    per 6-week (with &#8805;2 partial seizures per each of 3-week period) and with no 25-day
    seizure-free period in the 6-week period, as documented via a valid seizure diary. Only
    simple partial seizures with motor signs, complex partial seizures, and complex partial
    seizures with secondary generalization are counted toward this inclusion;
    9. Are currently being treated with stable doses of 1, 2 or a maximum of 3 approved AEDs.
    Only 1 inducer AED (defined as; carbamazepine, phenytoin, phenobarbital, or primidone
    only) out of the maximum of 3 AEDs is allowed;
    10. Are on a stable dose of the same concomitant AED(s) for 1 month (or no less than
    21 days) prior to Visit 1; in the case where a new AED regime has been initiated for a
    subject, the dose must be stable for 2 months (or no less than 49 days) prior to Visit 1;
    E.4Principal exclusion criteria
    1. Participated in a study involving administration of an investigational compound or device
    within 1 month (or no less than 21 days) prior to Visit 1, or within approximately 5 halflives
    of the previous investigational compound, whichever is longer;
    2. Pregnant and/or lactating;
    3. Participated in previous perampanel studies;
    4. Presence of nonmotor simple partial seizures only;
    5. Presence of primary generalized epilepsies or seizures, such as absences and or
    myoclonic epilepsies;
    6. Presence or previous history of Lennox-Gastaut syndrome;
    7. A history of status epilepticus within approximately 12 months prior to Visit 1;
    8. Seizure clusters where individual seizures cannot be counted;
    9. A history of psychogenic seizures;
    10. 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 the
    study conduct;
    11. 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;
    12. Evidence of significant active hepatic disease. Stable elevations 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 limit of normal
    (ULN);
    13. Evidence of significant active hematological disease; white blood cell (WBC) count
    &#8804; 2500/µL (2.50 1E+09/L) or an absolute neutrophil count &#8804; 1000/µL (1.00 1E+09/L);
    14. A clinically significant ECG abnormality, including prolonged QT defined as >450 msec;
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the percent change in seizure frequency per 28 days in
    the Maintenance Period relative to the Pre-randomization Phase in the ITT Population.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 No
    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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    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 months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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
    con consenso informato firmato da care giver
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state68
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 426
    F.4.2.2In the whole clinical trial 680
    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 Decision2008-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-03
    P. End of Trial
    P.End of Trial StatusCompleted
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