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    Summary
    EudraCT Number:2006-003887-76
    Sponsor's Protocol Code Number:11495A
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-05
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2006-003887-76
    A.3Full title of the trial
    ENSAYO CLINICO PILOTO CON MEMANTINA EN EL DÉFICIT COGNITIVO DE LA ESCLEROSIS MÚLTIPLE
    A.4.1Sponsor's protocol code number11495A
    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 SponsorICT (Instituto Científico y Técnológico de Navarra)
    B.1.3.4CountrySpain
    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 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 Ebixa
    D.2.1.1.2Name of the Marketing Authorisation holderH.Lundbeck A/S
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameMemantina
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMemantina
    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) 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 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
    Esclerosis Múltiple (EM)
    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
    Analizar la eficacia de la Memantina en mejorar el rendimiento en memoria empleando el test de Burschke
    E.2.2Secondary objectives of the trial
    1. Analizar la eficacia de la Memantina en mejorar la escala cognitiva BRB-Z, escalas de otros dominios cognitivos como atención (SDMT, Stroop) y función ejecutiva (Raven SPM), escalas de calidad de vida (SF-36), discapacidad (EDSS, MSFC, MSSS), de fatiga ( MFIS- 5) y de percepción de beneficio HMI.
    2. Demostrar diferencias significativas en los estudios de potenciales evocados atencionales entre pacientes tratados con Memantina y placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes con Esclerosis Múltiple definida según criterios McDonald 2001.
    2. Sexo: ambos en la misma proporción.
    3. Sujetos diestros (>70% Escala de Edimburgo)
    4. Lengua materna: castellano.
    5. Edad: >18 y < 60 años.
    6. Todos los subtipos de EM: Remitente-recurrente (RR), Secundaria-progresiva (SP), primaria-progresiva (PP) y progresiva-recurrente (PR).
    7. Consentimiento informado obtenido antes de comenzar el estudio siguiendo las directrices de la declaración de Helsinki.
    8. Pacientes estables en su discapacidad en los últimos 30 días previos a la inclusión y que confirmen que continuarán su tratamiento durante el periodo del estudio.
    9. Pacientes con EM con déficit cognitivo moderado-grave (>2 test anormales por debajo de 2SD respecto a nuestra población de referencia N=60 pareados por edad y nivel educativo) según los valores normativos de la batería BRB-N de nuestro centro.
    10. No se contempla limitación en la inclusión por discapacidad (EDSS, MSFC) ni tratamientos concomitantes: El tratamiento con interferón beta, acetato de Glatiramer, quimioterápicos, antiespásticos o anti-neurálgicos es aceptado, aunque los pacientes deberán haberlos iniciado al menos 1 mes antes de la inclusión.
    E.4Principal exclusion criteria
    1. Enfermedades psiquiátricas (Inventario neuropsiquiátrico de Cummings) y depresión (Escala de Hamilton para la depresión >8), consumo de drogas o alcohol, e historia de traumatismo craneoencefálico grave o con secuelas.
    2. Ausencia de consentimiento informado.
    3. Cualquier patología médica, quirúrgica o psiquiátrica que de acuerdo con el responsable del estudio pudiera resultar incompatible con el tratamiento a administrar, en especial epilepsia mal controlada y cardiopatía isquémica.
    4. Trataientos con fármacos antagonista NMDA como amantadina, ketamina y dextrometorfano.
    5. Sujeto en el que está contraindicado el tratamiento con Ebixa® (intolerabilidad o hipersensibilidad a algún componente del fármaco)
    6. Sujeto en tratamiento con benzodiacepinas ya que puede afectar al rendimiento cognitivo. pacientes en tratamiento esteroideo, hormonas o cualquier fármaco que pueda interferir en la ejecución cognitiva del sujeto (antihistamínicos, antihipertensivos…).
    7. Paciente que haya sufrido algún brote en los 30 días previos al estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Test Neuropsicológicos:
    - Batería Repetitiva Breve Normativizada de Rao (BRB-N)4. El BRB-N incluye 5 tests: test de memoria verbal de Burschke (Selective Reminder Test (SRT), test de memoria visual (10/36), test de atención y ejecutivo (symbol digit modalito test (SDMT) y paced serial auditory test (PASAT) 3 segundos) y test fonológico. Para el test PASAT se realizarán 3 ensayos para saturar el aprendizaje la primera vez. Emplearemos los valores normativos de la batería BRB-N de nuestro centro y el store global BRB-N Z5. mes 0-6-12
    -Test de Matrices Progresivas de Raven (SPM): mes 0- 6 -13.
    -Estudio de potenciales evocados atencionales: paradigma atencional go-no go
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.1.6Cross over Yes
    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 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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=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 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 state60
    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 Decision2007-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-30
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