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    Summary
    EudraCT Number:2018-003567-66
    Sponsor's Protocol Code Number:T817MAEU201
    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:2019-01-18
    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 number2018-003567-66
    A.3Full title of the trial
    A Phase 2 multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of T 817MA in patients with mild cognitive impairment due to Alzheimer’s Disease or mild Alzheimer’s Disease.
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y de fase 2 para evaluar la eficacia y la seguridad de T-817MA en pacientes con una deficiencia cognitiva leve debida a la enfermedad de Alzheimer o a la enfermedad de Alzheimer leve.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of T 817MA in patients with mild cognitive impairment due to Alzheimer’s Disease or mild Alzheimer’s Disease.Patients to be randomly allocated to either placebo or investigational drug; assignment will be unknown to patients and doctor.
    Estudio para evaluar la eficacia y seguridad del T 817MA en pacientes con deficiencia cognitiva leve debido a la enfermedad de Alzheimer o a la enfermedad de Alzheimer leve. Los pacientes serán asignados aleatoriamente a placebo o medicación en investigación; la asignación será desconocida para los pacientes y el médico.
    A.4.1Sponsor's protocol code numberT817MAEU201
    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 SponsorFUJIFILM Toyama Chemical Co., Ltd.
    B.1.3.4CountryJapan
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFUJIFILM Toyama Chemical Co., Ltd.
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJulius Clinical
    B.5.2Functional name of contact pointLarah de Groot
    B.5.3 Address:
    B.5.3.1Street AddressBroederplein 41-43
    B.5.3.2Town/ cityZeist
    B.5.3.3Post code3703 CD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031306569186
    B.5.6E-maillarah.degroot@juliusclinical.com
    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 No
    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 nameT817MA
    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 INNEdonerpic
    D.3.9.1CAS number 519187-97-4
    D.3.9.3Other descriptive nameT-817MA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number244
    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 placeboFilm-coated tablet
    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
    Mild cognitive impairment due to Alzheimer's Disease or mild Alzheimer's Disease.
    Leve deficiencia cognitiva (LDC) debido a la enfermedad de Alzheimer (EA) o EA leve.
    E.1.1.1Medical condition in easily understood language
    Mental disabilities due to Alzheimer's Disease or mild Alzheimer's Disease.
    Incapacidad mental debido a la enfermedad de Alzheimer o enfermedad de Alzheimer leve.
    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 LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10009846
    E.1.2Term Cognitive impairment
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the neuroprotective effect of T 817MA on Tau protein phosphorylated at threonine 181 (p-tau181) in CSF compared with placebo, in patients with a diagnosis of MCI due to AD or mild AD, according to the National Institute on Aging - Alzheimer Association (NIA-AA) criteria [Jack et al., 2018], with a Mini Mental Status Examination (MMSE) score of 24 to 30 (inclusive), and Aß and p-tau181 abnormality in CSF (≤1000 pg/ml for Aß, ≥19 pg/ml for p-tau181).
    El objetivo principal es evaluar el efecto neuroprotector de T-817MA sobre la proteína Tau fosforilada en la treonina 181 (p-tau181) en el líquido cefalorraquídeo (LCR) comparado con un placebo en pacientes que han recibido un diagnóstico de DCL debida a la EA o a la EA leve.
    E.2.2Secondary objectives of the trial
    To evaluate in patients on T-817MA and placebo:
    • cognitive function measured by the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) and Cognitive Functional Composite (CFC)
    • AD-related biomarkers in CSF (Tau protein phosphorylated at threonine 217 (p-tau217), total tau, Aβ1-40, Aβ1-42, neurofilament light (NFL), neurogranin, YKL-40 and Aβ1-42/Aβ1-40 ratio) and in plasma (Aβ1-40, Aβ1-42 and NFL)
    • imaging analysis using volumetric magnetic resonance imaging (vMRI)
    • alpha/theta ratio of the electroencephalogram (EEG)
    To evaluate the safety of T 817MA by clinical laboratory tests and AEs
    To evaluate the pharmacokinetics of T 817MA
    Evaluar en los pacientes que reciben T-817MA o placebo:
    • la función cognitiva, medida con la escala de valoración de demencia clínica, suma de cajas (CDR-sb), y los dominios de la memoria funcional y la atención, medidos con el conjunto funcional cognitivo (CFC)
    • biomarcadores relacionados con la EA en el LCR (proteína Tau fosforilada en treonina 217 (p-tau217), tau total, Aβ1-40, Aβ1-42, neurofilamento de cadena corta (NFL), neurogranina, YKL-40 y cociente Aβ1-42/Aβ1-40 y el plasma (Aβ1-40, Aβ1-42 y NFL)
    • análisis por imagen empleando la resonancia magnética nuclear volumétrica (RMNv)
    • cociente alfa/theta del electroencefalograma (EEG)
    Evaluar la seguridad de T-817MA según las pruebas clínicas de laboratorio y los acontecimientos adversos (AA).
    Evaluar las características farmacocinéticas de T-817MA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for enrolment:
    1. Male or female, age 50 to 80 inclusive at screening.
    2. Diagnosis by the investigator of a clinical syndrome of cognitive impairment consistent with either MCI due to AD or mild AD per NIA-AA diagnostic criteria (Jack et al., 2018), with MMSE 24 to 30 (inclusive).
    3. CSF results at screening consistent with the presence of Aß and p-tau181 abnormality (≤1000 pg/ml for Aß, ≥19 pg/ml for p-tau181).
    4. A brain MRI not-inconsistent with the clinical diagnosis of MCI due to AD or mild AD
    5. Recieving an AChE inhibitor (donepezil, galantamine or rivastigmine) at a stable dose for more than 3 months prior to randomization, or not receiving any AChE inhibitors.
    6. Weight of ≤ 100 kg (220 pounds) at Screening
    7. Ability (patients and their study partners) to read, speak and understand local language to ensure compliance with cognitive testing and study visit procedures
    8. Living in the community (includes assisted living facilities, but excludes long-term care nursing facilities)
    9. Ambulatory, or able to walk with an assistive device, such as a cane or walker
    10. Female patients must be post-menopausal for at least 2 consecutive years or surgically sterile (bilateral tubal ligation, hysterectomy or bilateral oophorectomy) for at least 6 months prior to Screening. Otherwise, female patients must have male sex partners use condoms, or the male partner must be confirmed azoospermic after vasectomy.
    11. A study partner who has regular contact with the patient for at least 10 hours per week and is able to oversee the patient’s compliance with study medication and participate in the patient’s clinical assessment
    12. Provision of informed consent from the patient and the study partner
    1. Personas de ambos sexos de entre 50 y 80 años (ambos incluidos).
    2. Diagnóstico por el investigador de un síndrome clínico deficiencia cognitiva congruente con DCL con la EA o a la EA leve según los criterios diagnósticos de la NIA-AA (Jack et al., 2018), con un MMSE de entre 24 y 30 (ambos incluidos).
    3. Resultados del LCR durante la selección congruentes con la presencia de una anomalía de Aß y p-tau181 (≤1000 pg/ml para Aß, ≥19 pg/ml para p-tau181).
    4. Resonancia magnética (RM) cerebral no inconsistente con el diagnóstico clínico de DCL debido a EA o EA leve.
    5. Toma una dosis estable de un inhibidor de la ACE (donepezilo, galantamina o rivastigmina) desde al menos 3 meses antes de la aleatorización, o no toma ningún inhibidor de la ACE.
    6. Peso ≤ 100 kg en la visita de selección
    7. Capacidad (pacientes y acompañantes del estudio) para leer, hablar y entender el idioma local para asegurar el cumplimiento de las pruebas cognitivas y los procedimientos de las visitas del estudio
    8. Vivir en comunidad (incluye instalaciones de viviendas asistidas, pero excluye las instalaciones de cuidados médicos a largo plazo)
    9. Ambulatorio, o capaz de andar con un dispositivo asistido (bastón, andador)
    10. Las mujeres deber ser post-menopáusicas al menos 2 años consecutivos o quirúrgicamente estériles (ligadura bilateral de las trompas, histerectomía o ooforectomía bilateral) al menos 6 meses antes de la visita de selección. De lo contrario, las mujeres deben tener parejas sexuales masculinas que usen condones, o se debe confirmar que la pareja masculina es azoospérmica después de la vasectomía.
    11. El acompañante del estudio tiene que tener contacto regular con el paciente al menos 10 horas a la semana y ser capaz de supervisar el cumplimiento del paciente con la medicación del estudio y participar en las pruebas clínicas del paciente.
    12. Otorgar el consentimiento informado al paciente y al acompañante del estudio
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria must not be included in the study:
    1. Has had an MRI of the brain within the previous 2 years that showed pathology that would be inconsistent with a diagnosis of AD
    2. Use of prohibited medications, including memantine.
    3. Has any contraindications for MRI including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI
    4. Has any contraindications to lumbar puncture
    5. Psychiatric disorder such as schizophrenia or dementia not of the Alzheimer’s type according to the criteria of DSM-5
    6. Other neurodegenerative diseases, including Parkinson’s disease and Huntington’s disease, or cerebral tumor
    7. Dementia other than AD
    8. History of untreated thyroid disorder, Type I diabetes, and insulin-dependent or uncontrolled Type II diabetes, as determined by the investigator (except non-insulin-controlled Type II diabetes, whose HbA1c value must be below 8.0 %)
    9. History of a seizure disorder and stroke, unless >5 years ago
    10. Current or systemic disorder that the investigator deems makes them ineligible
    11. History of alcohol abuse or dependence or drug abuse in the past 5 years
    12. Uncorrected impairment of vision or hearing that would preclude the patient from taking tests or patients lacking the ability to communicate
    13. Clinically significant abnormal laboratory values in the opinion of the investigator
    14. Clinically significant hepatic or renal impairment, or significant B12 deficiency (i.e., no macrocytosis) in the opinion of the investigator
    15. Severe heart disease (history of myocardial infarction, congestive heart disease, history of unstable angina pectoris, clinically significant ECG abnormality) within 6 months prior to screening. Patients with arterial thrombosis will not be excluded if they are stable for at least 6 months prior to Screening
    16. Cancer or a malignant tumor within the past 3 years, except patients who underwent potentially curative therapy with no evidence of recurrence. (Patients with stable untreated prostate cancer or skin cancers are not excluded.)
    17. Participation in another clinical trial for an investigational agent and having taken at least one dose of study medication, unless confirmed as having been on placebo, within 12 weeks prior to screening. (The end of a previous investigational trial is defined as the date of the last dose of an investigational agent.)
    18. Having received an active Aβ vaccine in another clinical trial
    19. Participation in a previous clinical trial with T 817MA
    20. Patients whom the investigator deems to be otherwise ineligible
    1. RM del cerebro en los 2 años previos que muestre una enfermedad incompatible con un diagnóstico de EA.
    2. Uso de medicación prohibida, incluye memantina.
    3. Cualquier contraindicación para la RM incluyendo claustrofobia, la presencia de implantes metálicos (ferromagnético), o un marcapasos cardíaco que no es compatible con la RM
    4. Cualquier contraindicación para la punción lumbar.
    5. Alteración psiquiátrica como esquizofrenia o demencia no de tipo Alzheimer según los criterios de DSM-5
    6. Otras enfermedades neurodegenerativas, incluyendo enfermedad de Parkinson y enfermedad de Huntington, o tumor cerebral
    7. Demencia que no sea EA
    8. Historial de alteración tiroidea no tratada, diabetes Tipo I, y diabetes Tipo II insulino-dependiente o incontrolada, como determine el investigador (excepto diabetes Tipo II controlada-no-insulino-dependiente, cuyo valor HbA1c debe ser menor de 8.0%)
    9. Historial de trastorno convulsivo y derrame cerebral, a menos que haya sido hace más de 5 años
    10. Trastorno actual o sistémico que el investigador considera que los hace no elegibles
    11. Historia de abuso de alcohol o dependencia o abuso de drogas en los últimos 5 años
    12. Deterioro no corregido de visión o audición que impediría que el paciente se sometiera a pruebas o que los pacientes carezcan de la capacidad de comunicarse
    13. Valores de laboratorio anormales clínicamente relevantes según la opinión del investigador
    14. Trastorno hepático o renal clínicamente relevantes, o deficiencia significativa de B12 (por ejemplo, no macrocitosis) según la opinión del investigador
    15. Enfermedad cardíaca severa (historial de infarto miocárdico, enfermedad cardíaca congestiva, historial de angina de pecho inestable, anomalía clínicamente significativa en el electrocardiograma) dentro de los 6 meses previos a la visita de selección. Los pacientes con trombosis arterial no serán excluidos si están estables al menos 6 meses antes de la visita de selección
    16. Cáncer o tumor maligno en los últimos 3 años, excepto en pacientes que se sometieron a una terapia potencialmente curativa sin evidencia de recurrencia. (Los pacientes con cáncer de próstata estable no tratado o cáncer de piel no serán excluidos)
    17. Participación en otro ensayo clínico de un agente en investigación y haber tomado al menos una dosis de la medicación de estudio, si no se confirma que ha tomado placebo, durante las 12 semanas previo a la visita de selección. (El final del ensayo clínico previo se define por la fecha de la última dosis del agente en investigación)
    18. Haber recibido una vacuna activa de Aβ en otro ensayo clínico
    19. Participación en ensayos clínicos previos con T 817MA
    20. Pacientes que el investigador considera que no son elegibles por otros motivos
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change in the CSF biomarker p-tau181 from Baseline to Week 78.
    La variable principal de eficacia es el cambio en el biomarcador p-tau181 del LCR desde el inicio hasta la semana 78.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, week 52 and week 78.
    Inicio, semana 52 y semana 78.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    1. The change in cognitive function assessed by CDR-sb and CFC from Baseline to Weeks 28, 52 and 78.
    2. The change in the CSF biomarker p-tau181 from Baseline to Week 52.
    3. The change in the CSF biomarkers p-tau217, total tau, Aβ1-42, Aβ1-40, NFL, neurogranin, YKL-40 and Aβ1-42/Aβ1-40 ratio from Baseline to Weeks 52 and 78.
    4. The change in plasma biomarkers Aβ1-42, Aβ1-40 and NFL from Baseline to Weeks 52 and 78.
    5. The change in brain volume (total brain volume (TBV), ventricular volume and hippocampal volume) and cortical thickness measured by vMRI from Baseline to Weeks 52 and 78
    6. The change in alpha/theta ratio measured by the EEG from Baseline to Weeks 52 and 78
    Las variables secundarias de eficacia son:
    1. El cambio en la función cognitiva, evaluado meidante la CRD-sb, y los dominios de la memoria funcional y la atención, medidos con el CFC, desde el inicio hasta las semanas 28, 52 y 78
    2. El cambio en el p-tau181 del LCR desde el inicio hasta la semana 52
    3. El cambio en los biomarcadores relacionados con la EA en el LCR (p-tau217, tau total, Aβ1-42, Aβ1-40, luz de los neurofilamentos [NFL], neurogranina, YKL-40 y cociente Aβ1-42/Aβ1-40) desde el inicio hasta las semanas 52 y 78
    4. El cambio en los biomarcadores de plasma relacionados con la EA en el plasma (Aβ1-42, Aβ1-40, NFL) desde el inicio hasta las semanas 52 y 78
    5. El cambio en el volumen cerebral (volumen total del cerebro [VTC], volumen ventricular y volumen del hipocampo) y el grosor cortical medidos mediante RMNv desde el inicio hasta las semanas 52 y 78
    6. El cambio en el cociente alfa/theta medido con el EEG desde el inicio hasta las semanas 52 y 78
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, week 52 and week 78.
    Inicio, semana 52 y semana 78.
    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 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) 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 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 No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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 Yes
    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 paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    A 4-week post-treatment observation period is included.
    After participation in the trial, the treating physician of the patient will consider appropriate treatment or care .
    Se incluye un periodo de observación de 4 semanas post-tratamiento.
    Después de la participación en el ensayo, el médico que trata al paciente valorará el tratamiento y cuidados adecuados.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-18
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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