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    Summary
    EudraCT Number:2020-004878-22
    Sponsor's Protocol Code Number:K170404J
    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:2020-12-03
    Trial 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 number2020-004878-22
    A.3Full title of the trial
    Pharmacokinetic and Placental Transfer of Levetiracetam
    Etude de la pharmacocinétique maternelle et du passage transplacentaire du Lévétiracétam
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetic and Placental Transfer of Levetiracetam
    Etude de la pharmacocinétique maternelle et du passage transplacentaire du Lévétiracétam
    A.3.2Name or abbreviated title of the trial where available
    EPICEINTE
    EPICEINTE
    A.4.1Sponsor's protocol code numberK170404J
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    B.5.2Functional name of contact pointDRCI, Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number33144841712
    B.5.5Fax number33144841701
    B.5.6E-mailalexandra.bruneau@aphp.fr
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Film-coated 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 INNLEVETIRACETAM
    D.3.9.1CAS number 102767-28-2
    D.3.9.4EV Substance CodeSUB08459MIG
    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 in pregnancy
    l'épilepsie pendant la grossesse
    E.1.1.1Medical condition in easily understood language
    Epilepsy in pregnancy
    l'épilepsie pendant la grossesse
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10015037
    E.1.2Term Epilepsy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To develop a population pharmacokinetic model of levetiracetam during pregnancy. After the study, this model could be used to propose dose adjustments to maintain stable concentrations in pregnant women throughout pregnancy.
    la pharmacocinétique du Lévétiracétam pendant la grossesse
    E.2.2Secondary objectives of the trial
    - Describe placental transfer during childbirth and during a medical termination of pregnancy
    - Explain the interindividual variability of maternal pharmacokinetics and transplacental passage of Levetiracetam.
    - Link the concentration and its variation in the individual to the effects of treatment
    - Décrire le passage transplacentaire à l’accouchement et au cours d’interruption médicale de grossesse
    - Expliquer la variabilité interindividuelle de la pharmacocinétique maternelle et du passage transplacentaire du Lévétiracétam.
    - Relier la concentration et sa variation chez l’individu aux effets du traitement
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Pregnant women of childbearing age who are pregnant
    - Age ≥18 years
    - Women with epilepsy treated with levetiracetam in monotherapy or combination
    - Affiliated to a social security scheme (or entitled)
    - Femmes en âge de procréer et enceinte
    - Age > 18 ans
    - Femmes épileptiques traitées par du Lévétiracétam en monothérapie ou en combinaison
    - affiliée à un régime de sécurité sociale (ou ayant droit)
    E.4Principal exclusion criteria
    - Women treated with antiepileptics for pathology other than epilepsy
    - Women treated with a combination of more than 3 antiepileptics
    - Severe anemia
    - Renal failure (moderate to severe)
    - Hepatic impairment (moderate to severe)
    - Alcohol and/or recreational drug use
    - Trend towards non-compliance with treatment
    - Inability to maintain a Crisis Observation Workbook
    - Suicidal Ideas
    - Uncontrolled thyroid disease
    - Woman under tutorship or curatorship
    - Patient under state medical assistance (AME)
    - Femme traitée par des antiépileptiques pour une pathologie autre que l’épilepsie
    - Femme traitée par une combinaison de plus de 3 antiépileptiques
    - Anémie sévère
    - Insuffisance rénale (modérée à sévère)
    - Insuffisance hépatique (modérée à sévère)
    - Consommation d'alcool et/ou de drogues récréatives
    - Tendance à la non observance des traitements
    - Incapacité à tenir un cahier d'observation des crises
    - Idées suicidaires
    - Maladie thyroïdienne non contrôlée
    - Femme sous tutelle ou curatelle
    - Patiente sous l’aide médicale de l’Etat (AME)
    E.5 End points
    E.5.1Primary end point(s)
    Levetiracetam pharmacokinetics in pregnancy (Levetiracetam concentrations as a function of time)
    la pharmacocinétique du Lévétiracétam pendant la grossesse (Concentrations de lévétiracétam en fonction du temps)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At delivery
    A l'accouchement
    E.5.2Secondary end point(s)
    1) Levetiracetam pharmacokinetics in pregnancy: Percentage of inter-individual variability in clearance or volume explained by a covariate (weight, serum creatinine, co-administration of other antiepileptics).
    2) Exposure ratio
    3) Link between levetiracetam concentrations and effects:
    - correlate the evolution of the concentrations in the woman (value in the woman whose treatment is balanced before the pregnancy minus the value when she is pregnant) to the effectiveness (number of crises that the patient did).
    - tolerance: presence or absence of clinical and biological abnormalities occurring in pregnant women and children.
    1) Expliquer la variabilité interindividuelle de la clairance d’élimination par d’autres facteurs tels que le poids, la créatininémie, la co-administration d’autres antiépileptiques.
    2) Estimation du passage transplacentaire des antiépileptiques comme un ratio d’exposition entre la mère et le fœtus
    3) Corréler l’évolution des concentrations chez la femme (valeur chez la femme dont le traitement est équilibré avant la grossesse versus valeur lorsqu’elle est enceinte) à :
    - l’efficacité (nombre de crises que la patiente aura faites).
    - la tolérance : anomalies cliniques et biologiques survenant chez la femme enceinte et chez le nouveau-né
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) at inclusion , until 17 weeks, until 28 weeks and until 6 week after delivery
    2) at delivery
    3)at inclusion , until 17 weeks, until 28 weeks and until 6 week after delivery
    1) à l'inclusion, jusqu'à 17 semaines, jusqu'à 28 semaines et jusqu'à 6 semaines après l'accouchement
    2) à l'accouchement
    3) à l'inclusion, jusqu'à 17 semaines, jusqu'à 28 semaines et jusqu'à 6 semaines après l'accouchement
    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 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 No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    non-comparative trial
    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 trial1
    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 concerned7
    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 No
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    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 state50
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-08-16
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