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    Summary
    EudraCT Number:2011-004030-33
    Sponsor's Protocol Code Number:RBHP2011PICKERING3
    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:2011-11-10
    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 number2011-004030-33
    A.3Full title of the trial
    Prévention du développement de douleur neuropathique post-mastectomie / tumorectomie par l’administration de mémantine en pré et post-chirurgie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prévention du développement de douleur neuropathique post-mastectomie / tumorectomie par l’administration de mémantine en pré et post-chirurgie
    A.3.2Name or abbreviated title of the trial where available
    Prophylaxie de la douleur neuropathique par la mémantine
    A.4.1Sponsor's protocol code numberRBHP2011PICKERING3
    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 SponsorCHU de Clermont-Ferrand
    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 supportCHU de Clermont-Ferrand
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Clermont-Ferrand
    B.5.2Functional name of contact pointPatrick LACARIN
    B.5.3 Address:
    B.5.3.1Street Address58, rue Montalembert
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number0033473751195
    B.5.5Fax number0033473754730
    B.5.6E-mailplacarin@chu-clermontferrand.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.2.1.1.1Trade name EBIXA 10mg
    D.2.1.1.2Name of the Marketing Authorisation holderLUNDBECK SAS
    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.3.1Product nameEBIXA 10mg
    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 INNMEMANTINE
    D.3.9.1CAS number 19982-08-2
    D.3.9.4EV Substance CodeSUB08731MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    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 EBIXA 20mg
    D.2.1.1.2Name of the Marketing Authorisation holderLUNDBECK SAS
    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.3.1Product nameEBIXA 20mg
    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 INNMEMANTINE
    D.3.9.1CAS number 19982-08-2
    D.3.9.4EV Substance CodeSUB08731MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboCapsule
    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
    Douleurs neuropathiques postmastectomie
    E.1.1.1Medical condition in easily understood language
    Douleurs neuropathiques postmastectomie
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    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
    L’objectif principal de cette étude est d’évaluer si la mémantine administrée en amont du geste chirurgical sur deux semaines puis maintenue sur deux semaines induit une diminution d’intensité douloureuse à 3 mois post-chirurgie, comparée au groupe placebo.
    E.2.2Secondary objectives of the trial
    Les objectifs secondaires de cette étude sont d’:
    - Evaluer la douleur des patientes en réponse au traitement pendant les 3 mois post-opératoires, et à 6 mois post-chirurgie.
    - Evaluer la consommation concomitante d’antalgiques (notamment de morphine) pendant les 3 mois post-opératoires,
    - Evaluer l’impact des traitements (mémantine/placebo) sur des paramètres cognitifs à la fin du traitement, à 3 mois et à 6 mois post-chirurgie.
    - Evaluer l’impact des traitements sur la qualité de vie des patientes à 3 mois et à 6 mois post-chirurgie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patiente âgée de plus de 18 ans,
    - Patiente atteinte du cancer du sein et ayant une mastectomie / tumorectomie programmée avec ou sans curage deux semaines après inclusion avec ou sans chimiothérapie préopératoire,
    - Coopération et compréhension suffisantes pour se conformer aux impératifs de l’étude,
    - Acceptation de donner un consentement écrit,
    - Affiliation au régime de la Sécurité Sociale française,
    - Inscription ou acceptation d’inscription au registre national des volontaires participant à des recherches.
    E.4Principal exclusion criteria
    - Patiente ayant une contre-indication à l’administration de la Mémantine:
    - Hypersensibilité à la substance active ou à l'un des excipients,
    - Hypertension artérielle,
    - Antécédent d'accident vasculaire cérébral,
    - Insuffisance cardiaque sévère,
    - Patiente diabétique (diabète de type I et II),
    - Patiente ayant des antécédents médicaux et/ou chirurgicaux jugés par l’investigateur ou son représentant comme étant non compatibles avec l’essai,
    - Patiente recevant un traitement composé de l’amantadine, la kétamine, le dextrometorphan, L-Dopa, agonistes dopaminergiques, anticholinergiques, barbituriques, neuroleptiques, IMAO, agents antispastiques, dantrolène ou baclofène, phénytoïne, cimétidine, ranitidine, procaïnamide, quinidine, quinine, nicotine, hydrochlorothiazide, warfarine,
    - Patiente ayant une addiction à l’alcool selon l’appréciation de l’investigateur,
    - Femme en âge de procréer n’utilisant pas une méthode contraceptive efficace, femme enceinte ou allaitante.
    - Patiente participant à un autre essai clinique, ou se trouvant dans la période d’exclusion, ou ayant reçu un montant total d’indemnités supérieur à 4500 euros sur les 12 mois précédant le début de l’essai,
    - Patiente ayant une coopération et une compréhension ne permettant pas de se conformer de façon stricte aux conditions prévues par le protocole,
    - Patiente bénéficiant d’une mesure de protection légale (curatelle, tutelle…),
    - Patiente non affiliée au régime de la Sécurité Sociale française
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation de l’intensité de la douleur moyenne évaluée sur les 5 jours précédant la visite de 3 mois post-chirurgie par échelle numérique, dans les groupes mémantine et placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation de l’intensité de la douleur moyenne évaluée sur les 5 jours précédant la visite de 3 mois post-chirurgie par échelle numérique, dans les groupes mémantine et placebo.
    E.5.2Secondary end point(s)
    - Evaluation de la douleur par échelle numérique :
    o pendant toute la période post-opératoire, toutes les 6 heures au sein du service de soins (et/ou selon le protocole utilisé dans le service) pendant les 15 premiers jours suivant la chirurgie,
    o puis évaluation quotidienne jusqu'à la visite à 3 mois,

    - Evaluation de la douleur moyenne sur les 5 jours précédant la visite à 6 mois post-chirurgie par échelle numérique,

    - Evaluation de la consommation d’antalgiques en post-opératoire sur 3 mois, en particulier la consommation de morphinique,

    - Evaluation de la douleur grâce au Questionnaire Concis sur les Douleurs QCD, à l’échelle DN4, au questionnaire Neuropathic Pain Symptoms Inventory (NPSI), au questionnaire de Saint Antoine (QDSA) et à l’échelle HAD,

    - Evaluation de l’impact sur la qualité de vie grâce au questionnaire SF36, au questionnaire d’évaluation du sommeil de Leeds,

    - Evaluation de l’impact cognitif grâce au Trail Making Test A et B et Digit Symbol Substitution Test.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Echelle numérique :période post-opératoire :toutes les 6 heures pendant les 15 premiers jours, puis évaluation quotidienne jusqu'à la visite à 3 mois, puis
    pendant les 5 jours précédant la visite à 6 mois post-chirurgie,

    - Consommation d’antalgiques en post-opératoire sur 3 mois,

    - Questionnaire Concis sur les Douleurs, échelle DN4, questionnaire Neuropathic Pain Symptoms Inventory, questionnaire de Saint Antoine et à l’échelle HAD, en J0-15, J0+16, J0 + 3 mois, J0 + 6 mois.

    - questionnaire SF36, questionnaire d’évaluation du sommeil de Leeds,en J0-15, J0+16, J0 + 3 mois, J0 + 6 mois.

    - tests Trail Making Test A et B et Digit Symbol Substitution Test en J0-15, J0+16, J0 + 3 mois, J0 + 6 mois.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Fin de l'essai = dernière visite du dernier patient
    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
    E.8.9.2In all countries concerned by the trial years1
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    Pas de différence avec la prise en charge habituelle de la pathologie.
    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 Decision2011-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
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