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    Summary
    EudraCT Number:2015-005625-39
    Sponsor's Protocol Code Number:I8D-MC-AZET
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-06-01
    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 number2015-005625-39
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer’s Disease Dementia (The DAYBREAK Study)
    Estudio aleatorizado, doble ciego, controlado con placebo y de comienzo aplazado de LY3314814 en la demencia de la enfermedad de Alzheimer leve (estudio DAYBREAK)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of LY3314814 in Participants With Mild Alzheimer's Disease Dementia (Daybreak)
    Estudio de LY3314814 en participantes con demencia de la enfermedad de Alzheimer leve (Daybreak)
    A.3.2Name or abbreviated title of the trial where available
    Daybreak Study
    Estudio Daybreak
    A.4.1Sponsor's protocol code numberI8D-MC-AZET
    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 SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number34916633473
    B.5.6E-mailensayosclinicos@lilly.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 nameLY3314814 20 mg film-coated tablets
    D.3.2Product code LY3314814
    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 INNNot yet available
    D.3.9.1CAS number 1522418-41-2
    D.3.9.2Current sponsor codeLY3314814
    D.3.9.3Other descriptive nameLY3314814
    D.3.9.4EV Substance CodeSUB181816
    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.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 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 nameLY3314814 50 mg film-coated tablets
    D.3.2Product code LY3314814
    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 INNNot yet available
    D.3.9.1CAS number 1522418-41-2
    D.3.9.2Current sponsor codeLY3314814
    D.3.9.3Other descriptive nameLY3314814
    D.3.9.4EV Substance CodeSUB181816
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 2
    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
    Alzheimer’s Disease with Dementia
    Enfermedad de Alzheimer con demencia
    E.1.1.1Medical condition in easily understood language
    Medical condition in which an individual's memory, judgment, cognition and eventually ability to function is destroyed.
    Afección médica en la que se destruyen la memoria, el sentido de la realidad, la capacidad intelectual y finalmente la capacidad funcional.
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10012271
    E.1.2Term Dementia Alzheimer's type
    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 test the hypothesis that LY3314814, administered orally at doses of 20 and 50 mg daily for 78 weeks, will slow the decline of AD as compared with placebo in patients with mild AD dementia
    Probar la hipótesis de que LY3314814, cuando se administra por vía oral a dosis diarias de 20 y 50 mg durante 78 semanas, ralentizará el deterioro asociado a la EA en comparación con un placebo en pacientes con demencia de la EA leve
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of LY3314814 on functional, clinical, and cognitive outcomes in patients with mild AD dementia at the end of the Placebo-Controlled period (week 78).
    To evaluate the relationship between treatment effect of LY3314814 and time.
    To test the hypothesis that LY3314814 will slow the rate of cognitive and functional decline associated with AD, compared with placebo
    To evaluate the efficacy of LY3314814 to prolong time in the current disease state
    To evaluate the effect of LY3314814 on CSF Aβ PD markers, CSF markers of neurodegeneration, brain amyloid burden, regional cerebral blood flow, brain aggregated tau levels, brain Metabolism and brain Atrophy
    Evaluar la eficacia de LY3314814 en los resultados funcionales, clínicos y cognitivos de los pacientes con demencia de la EA leve al final del periodo controlado con placebo (semana 78).
    Evaluar la relación entre el efecto del tratamiento de LY3314814 y el tiempo.
    Probar la hipótesis de que LY3314814 ralentizará la velocidad del deterioro cognitivo y funcional asociado a la EA en comparación con un placebo.
    Evaluar la eficacia de LY3314814 en la prolongación del tiempo en el estado patológico actual.
    Evaluar el efecto de LY3314814 en los marcadores FD de Aβ en el LCR, los marcadores de neurodegeneración en el LCR, la carga amiloide cerebral, el flujo sanguíneo cerebral regional, el nivel total de tau cerebral, el metabolismo cerebral y la atrofia cerebral.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Protocol Addendum I8D-MC-AZET (1) v 5-Feb-16, The objective of the FDG PET Biomarker addendum: To evaluate the effect of LY3314814 (change from baseline) on brain glucose metabolic rates using FDG PET
    1. Enmienda al protocolo I8D-MC-AZET (1) v 5-Feb-16, El objetivo de la enmienda de biomarcadorres FDG PET: Evaluar el efecto de LY3314814 (cambios desde el inicio) en las tasas metabolicas de glucosa en el cerebro usando FDG PET
    E.3Principal inclusion criteria
    • Participant must meet the National Institute on Aging (NIA) and the Alzheimer's Association (AA) (NIA-AA) criteria for probable AD dementia.
    • MMSE score of 20 to 26 inclusive at screening visit.
    • For a diagnosis of mild AD dementia, participant must have a CDR global score of 0.5 or 1, with the memory box score ≥0.5 at screening.
    • Evidence of amyloid pathology.
    • The participant must have a reliable study partner with whom he/she cohabits or has regular contact.
    • El participante debe cumplir los criterios del Instituto Nacional de Envejecimiento (National Institute on Aging, NIA) y de la Asociación del Alzheimer (AA) (NIA-AA) para la probable demencia de la EA.
    • Puntuación en el MMSE de 20 a 26, ambos inclusive, en la visita de selección.
    • Para que se le diagnostique demencia de la EA leve, el participante debe tener una puntuación global de la CDR de 0,5 o 1, con una puntuación en el apartado de memoria de ≥0,5 en la selección.
    • Indicios de patología amiloide.
    • El participante debe tener un compañero responsable con quien el/ella conviva o tenga contacto regular.
    E.4Principal exclusion criteria
    • Significant and/or current neurological disease affecting the central nervous system, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, repetitive head trauma, serious infection of the brain, Parkinson's disease, epilepsy, or cervicocranial vascular disease.
    • Participants with any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessment, or affect the participant's ability to complete the study. Participants with history of schizophrenia or other chronic psychosis are excluded.
    • Within 1 year before the screening visit or between screening and randomization, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptoms of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (such as, significant valvular disease, hypertrophic cardiomyopathy); or hospitalization for arrhythmia.
    • Congenital QT prolongation.
    • Intermittent second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.
    • A corrected QT (QTcF) interval measurement >470 milliseconds (men and women) at screening (as determined at the investigational site).
    • History of malignant cancer within the last 5 years.
    • History of vitiligo and/or current evidence of post-inflammatory hypopigmentation.
    • Calculated creatinine clearance <30 milliliters per minute (Cockcroft-Gault formula; Cockcroft and Gault 1976) at screening.
    • Currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
    • Enfermedades neurológicas significativas o actuales que afectan al sistema nervioso central distintas a la EA que puedan afectar a la capacidad intelectual o a la capacidad para completar el estudio, entre ellas, otras demencias, traumatismos craneales repetidos, infecciones cerebrales graves, enfermedad de Parkinson, epilepsia o enfermedad vascular cérvico-craneal.
    • Participantes a los que les hayan diagnosticado actualmente enfermedad psiquiátrica primaria distinta a la EA si, según el criterio del investigador, es posible que el trastorno o síntoma psiquiátrico confunda la interpretación del efecto del fármaco, afecte a la evaluación cognitiva o afecte a la capacidad del participante para completar el estudio. Los participantes con antecedentes de esquizofrenia u otras psicosis crónicas quedan excluidos.
    • Durante el año anterior a la visita de selección o entre la selección y la aleatorización, cualquiera de los siguientes: infarto de miocardio; insuficiencia cardíaca congestiva moderada o grave, clase III o IV de la Asociación de Cardiología de Nueva York; hospitalización (o síntomas) por una angina inestable; síncope provocado por hipotensión ortostática o síncope de causa no explicada; cardiopatía estructural significativa conocida (como valvulopatía significativa o miocardiopatía hipertrófica) u hospitalización por arritmia.
    • Prolongación del intervalo QT congénita.
    • Bloqueo auriculoventricular (AV) de segundo o tercer grado intermitente o disociación AV o antecedentes de taquicardia ventricular.
    • Medida del intervalo QT corregida (QTcF) >470 milisegundos (varones y mujeres) en la selección (según se determine en el centro de investigación).
    • Antecedentes de cáncer en los últimos 5 años.
    • Antecedentes de vitiligo o indicios actuales de hipopigmentación postinflamatoria.
    • Aclaramiento de creatinina calculado <30 mililitros por minuto (fórmula de Cockcroft-Gault; Cockcroft y Gault, 1976) en la selección.
    • Inclusión en la actualidad en cualquier otro ensayo clínico con un producto en investigación o en otro tipo de investigación médica que se considere médica o científicamente incompatible con este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog-13) Score
    Cambios en la puntuación de la subescala cognitiva de la escala de evaluación de la enfermedad de Alzheimer (ADAS-Cog-13) con respecto al inicio
    E.5.1.1Timepoint(s) of evaluation of this end point
    78 weeks from baseline
    78 semanas desde el inicio
    E.5.2Secondary end point(s)
    • Change from Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-iADL) Instrumental Items Score
    • Change from Baseline in Functional Activities Questionnaire (FAQ) Score
    • Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
    • Change from Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
    • Change in Clinical Dementia Rating (CDR) Global Score
    • Change from Baseline in Neuropsychiatric Inventory (NPI) Score
    • Change from Baseline on the Mini-Mental State Examination (MMSE)
    • Change from Baseline in Concentration of Cerebrospinal fluid (CSF) Biomarker Aβ1-42
    • Change from Baseline in Concentration of CSF Biomarker Aβ1-40
    • Change from Baseline in CSF Biomarker Total Tau
    • Change from Baseline in CSF Biomarker Phosphorylated Tau
    • Change from Baseline in Brain Amyloid Burden using Florbetapir Amyloid Scan
    • Change from Baseline in Regional Cerebral Blood Flow (rCBF) using Florbetapir Perfusion Scan
    • Change from Baseline in Whole Brain Volume
    • Population Pharmacokinetics (PK): Apparent Oral Clearance of LY3314814
    • Population PK: Central Volume of Distribution of LY3314814
    • Cambios en la puntuación de los apartados instrumentales del cuestionario de actividades cotidianas del estudio cooperativo de la enfermedad de Alzheimer (Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory, ADCS-iADL) con respecto al inicio
    • Cambios en la puntuación del cuestionario de actividades funcionales (Functional Activities Questionnaire, FAQ) con respecto al inicio
    • Cambios en la puntuación de la escala de clasificación de la enfermedad de Alzheimer (Integrated Alzheimer’s Disease Rating Scale, iADRS) con respecto al inicio
    • Cambios en la puntuación de la suma de recuadros de la evaluación de demencia clínica (Clinical Dementia Rating - Sum of Boxes, CDR-SB) con respecto al inicio
    • Cambios en la puntuación global de la escala de valoración clínica de la demencia (Clinical Dementia Rating, CDR)
    • Cambios en la puntuación del inventario neuropsiquiátrico (Neuropsychiatric Inventory, NPI) con respecto al inicio
    • Cambios en el miniexamen cognoscitivo (Mini-Mental State Examination, MMSE) con respecto al inicio
    • Cambios en la concentración del biomarcador Aβ1-42 en el líquido cefalorraquídeo (LCR) con respecto al inicio
    • Cambios en la concentración del biomarcador Aβ1-40 en el LCR con respecto al inicio
    • Cambios en el biomarcador tau total en el LCR con respecto al inicio
    • Cambios en el biomarcador tau fosforilada en el LCR con respecto al inicio
    • Cambios en la carga amiloide cerebral con respecto al inicio mediante una exploración del amiloide con florbetapir
    • Cambios en el flujo sanguíneo cerebral regional (FSCr) con respecto al inicio mediante una exploración por perfusión con florbetapir
    • Cambio del volumen total del cerebro con respecto al inicio
    • Farmacocinética (FC) de la población: aclaramiento oral aparente de LY3314814
    • FC de la población: volumen de distribución central de LY3314814
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timeframe for most endpoints is 78 weeks from baseline
    Exception is Population (PK) - Pre-dose week 4 through week 71
    El plazo para la mayoría de los criterios de valoración es de 78 semanas desde el inicio.
    Excepto la población para FC, que será desde la semana 4 antes de la administración hasta la semana 71
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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) 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Comienzo aplazado
    Delayed-Start
    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 trial4
    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 EEA85
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    China
    Czech Republic
    Denmark
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Portugal
    Russian Federation
    Spain
    Taiwan
    United Kingdom
    United States
    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
    Efficacy Study
    Estudio de la eficacia
    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 years5
    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: 570
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3230
    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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 630
    F.4.2.2In the whole clinical trial 3800
    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)
    As defined in the protocol
    Tal y como esta definido en el protocolo
    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 Decision2016-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-06-12
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