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    Summary
    EudraCT Number:2008-008481-12
    Sponsor's Protocol Code Number:DON-IIG-165
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-02-19
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-008481-12
    A.3Full title of the trial
    Tratamiento de la Afasia Post-ictus con Donepezilo y Rehabilitación Grupal Intensiva de la Afasia: Análisis de la Reorganización Funcional de la Redes del Lenguaje con Neuroimagen Estructural y Funcional.
    Treatment of post-stroke aphasia with donepezil and constraint-induced aphasia therapy: Analysis of functional reorganization of language networks with structural and functional neuroimaging
    A.4.1Sponsor's protocol code numberDON-IIG-165
    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 SponsorMarcelo L. Berthier Torres
    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 ARICEPT FLAS 10 mg, comprimidos bucodispersbles
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER, S.A.
    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.3.4Pharmaceutical form Orodispersible 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 INNDONEPEZILO HIDROCLORURO
    D.3.9.3Other descriptive nameDONEPEZIL HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 10
    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
    Tratamiento de la Afasia crónica con Donepezilo
    Treatment of chronic aphasia with Donepecil
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level PT
    E.1.2Classification code 10002948
    E.1.2Term Aphasia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •Examinar si el tratamiento con Donepezilo solo o asociado a REGIA es eficaz en la afasia crónica post-ictus.

    •Examinar el metabolismo en las áreas que rodean al infarto cerebral (“penumbra isquémica”) y en las áreas distantes a ellas en el hemisferio cerebral ipsilateral y contralateral y en el cerebelo (“diasquisis”) en la evaluación basal y después de Donepezilo solo y asociado a REGIA.

    •Examinar los cambios en el patrón de activación cerebral durante tareas de lenguaje.
    E.2.2Secondary objectives of the trial
    Determinar si la administración de Donepezilo solo y Donepezilo asociado a REGIA mejora la denominación oral de objetos con el subtest de la Evaluación del Procesamiento Lingüístico en la Afasia (EPLA), tareas de tiempo de reacción luadas con el California Computerized Assessment Package (CalCAP).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Pacientes adultos con edades comprendidas entre 18 y 70 años.
    • Pacientes diagnosticados de afasia (cociente de afasia de la Western Aphasia Battery &#61603; 93.8 puntos)
    asociada a accidentes cerebrovasculares.
    • Pacientes que tengan un tiempo de evolución de la afasia &#61619; 6 meses.
    • Pacientes con lesiones únicas o múltiples (que hayan ocurrido en el mismo episodio) en
    el hemisferio cerebral izquierdo por pruebas de neuroimagen (TAC o RMN).
    • Pacientes con escolaridad primaria completa o superior.
    • Pacientes que puedan completar el protocolo de evaluación.
    • Pacientes ambulatorios en condiciones físicas aceptables para la administración del
    tratamiento y que se encuentren viviendo con un familiar o cuidador capaz y con voluntad
    de informar sobre la evolución del paciente.
    • Firma de Consentimiento Informado por el paciente o su representante legal.
    E.4Principal exclusion criteria
    • Pacientes con enfermedades neurológicas (por ej. epilepsia grave, traumatismo cráneo-encefálico) o médicas (por ej., EPOC, apnea de sueño) concomitantes que puedan alterar la función cognitiva.
    • Presencia de afasia grave (mutismo, recurrencias CVC o CV, jerga neologística, o puntuación < 4 en el subtest de comprensión de la WAB)
    • Pacientes con demencia vascular o degenerativa (por ej., enfermedad de Alzheimer) u otro tipo de enfermedades degenerativas que cursan con demencia (por ej., enfermedad de Parkinson).
    • Pacientes con antecedentes de enfermedades mentales graves distintas a la demencia (por ej., esquizofrenia) que puedan alterar la función cognitiva.
    • Pacientes que estén siendo tratados o hayan recibido el mes anterior a la inclusión en el estudio fármacos con probada acción en la función cognitiva (agonistas dopaminérgicos, GABA-miméticos, antidepresivos).
    • Pacientes con enfermedades médicas (enfermedad pulmonar obstructiva crónica o asma bronquial grave, cardiopatía grave o inestable.
    • Pacientes con contraindicaciones para someterse a pruebas de imagen (RMN y PET): Marcapasos, claustrofobia, alergia a contrastes, embarazo, etc.
    E.5 End points
    E.5.1Primary end point(s)
    • Western Aphasia Battery (WAB)
    • Communicative Ability Log (CAL).
    • PET: cambios en el metabolismo respecto a la evaluación basal
    • RMNf: mayor activación de regiones estructuralmente indemnes durante la ejecución de paradigmas de Activación (denominación de dibujos de objetos).
    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 Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 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 years0
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    posiblemente un número pequeño de pacientes afásicos (20%) necesite que un familiar o representante legal firme el consentimiento
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    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)
    Continuidad de rehabilitación logopédica de la afasia y posibilidad de acceder al tratamiento por uso compasivo.
    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 Decision2009-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-26
    P. End of Trial
    P.End of Trial StatusOngoing
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