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    Summary
    EudraCT Number:2017-002858-36
    Sponsor's Protocol Code Number:FIM-DON-2017-01
    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:2018-08-02
    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 number2017-002858-36
    A.3Full title of the trial
    STUDY OF THE EFFECTIVENESS AND CEREBRAL REORGANIZATION AFTER TREATMENT COMBINED WITH DONEPEZILO, INTENSIVE REHABILITATION AND TRANSCRANEAL DIRECT CURRENT STIMULATION IN POSTSTROKE CHRONIC AFASIA
    ESTUDIO DE LA EFICACIA Y REORGANIZACIÓN CEREBRAL TRAS TRATAMIENTO COMBINADO CON DONEPEZILO, REHABILITACIÓN INTENSIVA Y ESTIMULACIÓN TRANSCRANEAL DE CORRIENTE DIRECTA EN LA AFASIA CRÓNICA POSTICTUS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY OF THE EFFECTIVENESS OF THE COMBINED TREATMENT WITH DONEPEZILO, INTENSIVE REHABILITATION AND ELECTRIC STIMULATION OF THE BRAIN IN PATIENTS WITH AFASIA AFTER STROKE
    ESTUDIO DE LA EFICACIA DEL TRATAMIENTO COMBINADO CON DONEPEZILO, REHABILITACIÓN INTENSIVA Y ESTIMULACIÓN ELECTRICA DEL CEREBRO EN PACIENTES CON AFASIA TRAS INFARTO CEREBRAL
    A.4.1Sponsor's protocol code numberFIM-DON-2017-01
    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 SponsorFIMABIS Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina Y Salud
    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 supportInstituo de Salud Carlos III (ISCIII)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFIMABIS Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina Y Salud
    B.5.2Functional name of contact pointPlataforma de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street AddressEstudios Clínicos, 7ª Planta, Pabellón A, Hospital Regional Universitario, Avda. Carlos Haya s/n
    B.5.3.2Town/ cityMálaga
    B.5.3.3Post code29010
    B.5.3.4CountrySpain
    B.5.4Telephone number+34951291977
    B.5.6E-mailestudios.clinicos@fimabis.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDONEPEZIL
    D.3.9.1CAS number 120014-06-4
    D.3.9.4EV Substance CodeSUB06362MIG
    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) 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
    Chronic poststroke aphasia
    Afasia crónica Postictus
    E.1.1.1Medical condition in easily understood language
    Chronic poststroke aphasia
    Afasia (pérdida parcial del lenguaje) crónica tras daño vascular adquirido infarto o derrame cerebral
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10002948
    E.1.2Term Aphasia
    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 examine the effects of donepezil, Intensive Group Rehabilitation of Aphasia (REGIA) plus (REGIA + repetition / imitation task) and transcranial direct current anodal stimulation (A-tDCS) on the severity of language disorders and associated disorders (communication , behavior, and quality of life) secondary to lesions in the left perisylvian area in patients with chronic post-stroke aphasia.
    Examinar los efectos de donepezilo, Rehabilitación Grupal Intensiva de la Afasia (REGIA) plus (REGIA + tarea de repetición/imitación) y estimulación transcraneal de corriente directa anodal (A-tDCS) en la gravedad de los trastornos del lenguaje y trastornos asociados (comunicación, conducta, y calidad de vida) secundarios a lesiones en el área perisilviana izquierda en pacientes con afasia crónica post-ictus (ACPI).
    E.2.2Secondary objectives of the trial
    • Evaluate possible changes in cognitive non-linguistic functions (attention, short-term verbal memory and cognitive control) and its relationship with the improvement in the linguistic domain.
    • Examine, through the use of different neuroimaging techniques, the structural, functional and metabolic changes in the gray and white matter (tracts) and explore changes in connectivity (MRI at rest) and the biochemical markers (spectroscopy) promoted by the interventions made.
    • Analyze whether the microstructural integrity (tractography) of regions not damaged by stroke act as surrogate indicators of prediction of response to different treatments, which will allow a better selection of therapeutic strategies in future studies.
    • Evaluate if the benefits achieved in different domains are maintained in the long term (three months) after the interruption of the treatments.
    • Evaluar posibles cambios en funciones cognitivas no-lingüísticas (atención, memoria verbal a corto plazo y control cognitivo) y su relación con la mejoría en el dominio lingüístico.
    • Examinar mediante el uso de diferentes técnicas de neuroimagen los cambios estructurales, funcionales y metabólicos en la sustancia gris y blanca (tractos) y explorar cambios en la conectividad (RMN en estado de reposo) y los marcadores bioquímicos (espectroscopia) promovidos por las intervenciones realizadas.
    • Analizar si la integridad microestructural (tractografía) de las regiones no dañadas por el ictus actúan como indicadores subrogados de predicción de respuesta a los diferentes tratamientos lo que permitirá una mejor selección de estrategias terapéuticas en estudios futuros.
    • Evaluar si los beneficios alcanzados en diferentes dominios se mantienen a largo plazo (tres meses) tras la interrupción de los tratamientos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects.
    2. Ages between ≥18 and ≤70 year old.
    3. Right-handed subjects (rank: + 80 + 100 in the Edinburgh Handedness Inventory).
    4. Spanish or Catalan as a native language.
    5. At least basic education.
    6. Having suffered infarctions or single cerebral hemorrhages restricted to the left cerebral hemisphere.
    7. Diagnosis of aphasia established by a score in the Aphasia Quotient of the Spanish version of the Western Aphasia Battery (WAB)<93.8 and with clinical profile of driving aphasia (AC) in any of its 4 variants (repeat AC , AC of reproduction, AC simil-Broca, AC simil-Wernicke).
    1. Ambos sexos.
    2. Edades comprendidas entre ≥18 y ≤70 años.
    3. Sujetos diestros (rango: + 80 + 100 en el Edinburgh Handedness Inventory).
    4. Español o catalán como idioma nativo.
    5. Al menos educación básica.
    6. Haber sufrido infartos o hemorragias cerebrales únicas restringidas al hemisferio cerebral izquierdo.
    7. Diagnóstico de afasia establecido por una puntuación en el Cociente de Afasias de la versión española de la Western Aphasia Battery (WAB)<93.8 y con perfil clínico de afasia de conducción (AC) en cualquiera de sus 4 variantes (AC de repetición, AC de reproducción, AC simil-Broca, AC simil-Wernicke).
    E.4Principal exclusion criteria
    1. Dysarthria without aphasia.
    2. Multiple or bilateral injuries.
    3. High risk of suffering a new stroke or unstable neurological condition (eg, transient ischemic attacks).
    4. History of severe psychiatric illness (schizophrenia, severe depression, bipolar disorder, anxiety disorders).
    5. Use or abuse of alcohol and other substances of abuse.
    6. Coexistence of aphasia with dementia.
    7. Serious alterations of language (mutism, CV or CVC stereotypes, neologistic jargon, or a score on the WAB Understanding subtest <4).
    8. Severe visual agnosia, severe ideomotor/ideational apraxia.
    9. Severe speech apraxia where group therapy (REGIAplus) cannot be performed.
    10. Pregnancy.
    11. Recent myocardial infarction, decompensated cardiac failure, cardiac blocks, bradycardia, uncontrolled arterial hypertension.
    12. Epilepsy.
    13. Sensitivity to Donepezil or being treated with drugs that interfere with Donepezil (anticholinergics).
    1. Disartria sin afasia.
    2. Lesiones múltiples o bilaterales.
    3. Riesgo elevado de sufrir un nuevo ictus o condición neurológica inestable (p. ej., accidentes isquémicos transitorios).
    4. Historia de enfermedad psiquiátrica grave (esquizofrenia, depresión grave, trastorno bipolar, trastornos de ansiedad).
    5. Uso o abuso de alcohol y otras sustancias.
    6. Coexistencia de la afasia con demencia.
    7. Alteraciones graves del lenguaje (mutismo, estereotipias CV o CVC, jerga neologística, o una puntuación en el subtest de comprensión de la WAB < 4).
    8. Agnosia visual grave, apraxia ideomotora/ideacional grave.
    9. Apraxia del habla grave que impidan la administración de REGIA.
    10. Embarazo.
    11. Infarto de miocardio reciente, fracaso cardíaco descompensado, bloqueos cardíacos, bradicardia, hipertensión arterial no-controlada.
    12. Epilepsia.
    13. Sensibilidad al Donepezilo o estar recibiendo tratamiento con fármacos que interfieren con el Donepezilo (an
    E.5 End points
    E.5.1Primary end point(s)
    Gravity of aphasia: Aphasia ratio of the Western Aphasia Battery (WAB).
    Changes in communication: Communicative Ability Log (CAL).
    Changes in mood (Depression): Stroke Aphasic Depression Questionnaire (SADQ).
    Changes in quality of life: Stroke Aphasia Quality of Life 39 (SAQoL39).
    Gravedad de la afasia: Cociente de afasia de la Western Aphasia Battery (WAB).
    Cambios en la comunicación: Communicative Ability Log (CAL).
    Cambios en el estado de ánimo (Depresión): Stroke Aphasic Depression Questionnaire (SADQ).
    Cambios en la calidad de vida: Stroke Aphasia Quality of Life 39 (SAQoL39).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 0 (baseline) , week 8, week 10 and week 22
    Semana 0 (basal), semana 8, semana 10 y semana 22
    E.5.2Secondary end point(s)
    • WAB Subtests including: spontaneous language, listening comprehension, repetition and denomination.
    • Battery Assessment Aphasic Disorders - BETA (tests: 1, 2, 4, 5, 6, 13, 14, 19, 20, 21, and 26)
    • Attention: WISC-IV Repetition of digits.
    • Repeat clichés / novel phrases
    • New words learning task
    • Executive function (BADS test).
    • Function of the right hemisphere (cubes of Corsi, line orientation judgment).
    • Attention Network Test (ANT)
    • Catastrophic Reaction Scale
    • Structural and functional neuroimaging (changes in functional MRI, resting MRI, tensor diffusion NMR - tractography, cortical thickness measurements).
    • Subtests de la WAB que incluyen: lenguaje espontáneo, comprensión auditiva, repetición y denominación.
    • Batería Evaluación Trastornos Afásicos – BETA (tests: 1, 2, 4, 5, 6, 13, 14, 19, 20, 21, y 26)
    • Atención: Repetición de dígitos WISC-IV.
    • Repetición clichés/frases noveles
    • Tarea de aprendizaje de nuevas palabras
    • Función ejecutiva (test BADS).
    • Función del hemisferio derecho (cubos de Corsi, juicio de orientación de la línea).
    • Attention Network Test (ANT)
    • Escala Reacción Catastrófica
    • Neuroimagen estructural y funcional (cambios en RMN funcional, RMN en estado de reposo, RMN de tensor difusión – tractografía, medidas de espesor cortical).
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 0 (baseline), week 8 and week 10
    Semana 0 (basal), semana 8 y semana 10
    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 Yes
    E.6.13.1Other scope of the trial description
    Intervention includes donepezil, REGIAplus and A-tDCS. Pharmacologic side of the intervention, Donepezil, is used for a different indication of those approved on its Marketing Authorization.

    Randomization, double blinding and control with placebo refers to the tDCS.
    La intervención incluye Donepezilo, REGIAplus y A-tDCS. La parte farmacológica de la intervención, Donepezilo, se usa en una indicación diferente a las aprobadas en su Autorización de Comercialización.

    La aleatorización, el doble ciego y el control con placebo están relacionados con la estimulación transcraneal de corriente (tDCS).
    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) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3.1Comparator description
    Falsa Estimulación de Corriente Directa transcraneal (S-tDCS)
    Sham transcranial Direct Current Stimulation (S-tDCS)
    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
    LVLS.
    Última visita del último sujeto de estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 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)
    Once subject’s participation in the study is finished, he/she will be offered the best treatment available for his/her condition.
    Una vez finalizada su participación en el estudio, a los sujetos de estudio se les ofrecerá la mejor opció terapeútica disponible para su condición.
    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 Decision2018-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-30
    P. End of Trial
    P.End of Trial StatusOngoing
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