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    Summary
    EudraCT Number:2010-019268-35
    Sponsor's Protocol Code Number:SP1007
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-29
    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 ConcernedFrance - ANSM
    A.2EudraCT number2010-019268-35
    A.3Full title of the trial
    A MULTI-CENTER, OPEN-LABEL STUDY TO EVALUATE THE TOLERABILITY, SAFETY AND EFFICACY OF LACOSAMIDE (200 mg - 400mg/day) AS ADD-ON THERAPY FOR PATIENTS WITH PARTIAL ONSET EPILEPSY USING A FLEXIBLE DOSE-ESCALATION SCHEDULE AND INDIVIDUALIZED MAINTENANCE DOSES
    A.3.2Name or abbreviated title of the trial where available
    SELF
    A.4.1Sponsor's protocol code numberSP1007
    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 SponsorUCB Pharma SA
    B.1.3.4CountryFrance
    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 Yes
    D.2.1.1.1Trade name Vimpat
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Partial onset epilepsy with or without generalization
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    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
    The objective is to evaluate if a flexible dose escalation, up to 400mg/day (maximum recommended dose), or to a lower dose, clinically effective for an individual patient, improves lacosamide (Vimpat) tolerability.
    E.2.2Secondary objectives of the trial
    The objective is to evaluate if a flexible dose escalation, up to 400mg/day (maximum recommended dose), or to a lower dose, clinically effective for an individual patient, improves lacosamide (Vimpat) effectiveness.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Independent Ethics Committee (IEC) approved written informed consent is signed and dated by the patient (adult or minor) and by the parent(s) or legal representative if applicable.

    2. Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule or medication intake according to the judgment of the investigator.

    3. Subject is male or female, ≥ 16 years old.

    4. Patient has epilepsy and is experiencing partial-onset epilepsy, whether or not secondarily generalized, classifiable according to the International Classification of Epileptic Seizures confirmed by appropriate diagnosis.

    5. Patient presents with between 1 and 14 partial-onset seizures per month over a 3-month historical Baseline seizure count.

    6. Patient is being treated with 1 or 3 concomitant marketed antiepileptic drugs at study entry. Benzodiazepine taken chronically, whatever the indication is permitted and counted as 1 of the anticonvulsant treatments. Vagus-nerve stimulation is permitted as a concomitant treatment provided that at the entry visit, the device has been implanted for more than 6 months and the stimulation parameters have been stable for at least 1 month prior to the entry visit. Vagus-nerve stimulation will be counted as a concomitant antiepileptic drug.

    7. Concomitant antiepileptic drugs are taken at a stable dose regimen for at least 4 weeks before the entry visit.
    E.4Principal exclusion criteria
    1. Previous exposure to VIMPAT®.

    2. Subject has participated in another study of an investigational medication (or a medical device) within the last 2 months or is currently participating in another study.

    3. Subject has a history of questionable compliance to visit schedule or medication intake; subject not expected to complete the study.

    4. Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject’s ability to participate in this study.

    5. Subject has a known hypersensitivity to any components of VIMPAT® tablets (lacosamide, soja or peanuts or any of the excipients).

    6. Subject has a known II° or III° AV-block.

    7. Subject with partial onset seizures that are not clearly identifiable (ex seizures limited to psychic auras, or subtle vegetative changes).

    8. Subject has a history of generalized epilepsy.

    9. Subject has a history of status epilepticus within the 12-month period prior to the inclusion into the study.

    10. Patient has seizures that are uncountable due to clustering during the 12 week period prior to inclusion.

    11. Patient has a current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic events that could be confused with seizures.

    12. Subject is pregnant or nursing and/or a woman of childbearing potential who is not surgically sterile, 2 years postmenopausal or does not practice adequate contraception, for the duration of the study.

    13. Subject has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation.

    14. Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion (e.g., end stage renal disease, patients on dialysis, patients with severe hepatic impairment). Patients with mild to moderate renal impairment may participate in the study.

    15. Subject has a progressive cerebral disease, a progressive degenerative neurological disease or a cerebral tumor.

    16. Patient is taking any of the following concomitant medications:
    Subject is currently on felbamate.
    Subject is currently on vigabatrin, or subject has been on vigabatrin and no visual fields examination report is available, including standard static (Humphrey or Octopus) or kinetic perimetry (Goldman), or if results of these examinations are abnormal.
    E.5 End points
    E.5.1Primary end point(s)
    Safety assessments will be made using the spontaneous reporting of adverse events.
    - Incidence of AEs: Serious AE, TEAE, discontinuation or LCM dose reduction because of any TEAE
    - Additional safety variables including vital signs, neurological and physical examination abnormalities.
    - AE frequency by study period, titration and maintenance.
    - AE frequency by concomitant AEDs exposure (by each AED and by class Na+ channel /not)
    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 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned43
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    The end of the study is defined as the last visit of the last patient in the study.
    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 months0
    E.8.9.1In the Member State concerned days0
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    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 Decision2010-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-19
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