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    Summary
    EudraCT Number:2019-001436-54
    Sponsor's Protocol Code Number:CL06-ORY-2001
    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:2019-04-30
    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 number2019-001436-54
    A.3Full title of the trial
    A single-center, open-label, single-arm, 13-week study to evaluate the efficacy, safety and tolerability of ORY-2001 in aggression in Alzheimer’s Disease (AD) – REIMAGINE-AD
    Estudio abierto, unicéntrico, con un brazo de tratamiento activo, de 13 semanas de duración, para evaluar la eficacia, seguridad y tolerabilidad de ORY-2001 en el tratamiento de la agresividad en la enfermedad de Alzheimer (EA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy, safety and tolerability of ORY-2001 in aggression in Alzheimer’s Disease (AD) – REIMAGINE-AD
    Estudio para evaluar la eficacia, seguridad y tolerabilidad de ORY-2001 en el tratamiento de la agresividad en la enfermedad de Alzheimer (EA)
    A.3.2Name or abbreviated title of the trial where available
    REIMAGINE-AD
    REIMAGINE-AD
    A.4.1Sponsor's protocol code numberCL06-ORY-2001
    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 SponsorOryzon Genomics S. A.
    B.1.3.4CountrySpain
    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 supportOryzon Genomics S. A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOryzon Genomics S. A.
    B.5.2Functional name of contact pointRoger Bullock
    B.5.3 Address:
    B.5.3.1Street AddressSant Ferran 74
    B.5.3.2Town/ cityCornellá Llobregat
    B.5.3.3Post code08940
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 93 515 13 13
    B.5.5Fax number+34 93 377 40 28
    B.5.6E-mailrbullock@oryzon.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 nameVafidemstat
    D.3.2Product code ORY-2001
    D.3.4Pharmaceutical form Capsule, hard
    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 INNORY-2001 (Vafidemstat)
    D.3.9.1CAS number 1357247-95-0
    D.3.9.3Other descriptive nameORY-2001 (Vafidemstat)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.2
    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
    Aggression in Alzheimer’s Disease (AD)
    Agresión en la Enfermedad de Alzheimer
    E.1.1.1Medical condition in easily understood language
    Aggression in Alzheimer’s Disease
    Agresión en la Enfermedad de Alzheimer
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the efficacy of ORY-2001 in aggression in an AD population
    Investigar la eficacia de ORY-2001 en el tratamiento de la agresividad en pacientes con EA
    E.2.2Secondary objectives of the trial
    - To investigate other changes on behaviour, cognition and caregiver burden
    - To evaluate the safety and tolerability of ORY-2001 in an AD population
    - Investigar otros cambios en el comportamiento, la cognición y la carga del cuidador.
    - Evaluar la seguridad y la tolerabilidad de ORY-2001 en pacientes con EA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women between 50-85 years of age

    2. Diagnosis of Probable AD according to NIA-AA criteria (McKhann GM et al, 2011)

    3. Body mass index (BMI) of at least 18.5 kg/m2

    4. Significant or persistent agitation or aggression that was disruptive to patient’s daily living or put the patient in harm´s way for at least 3 days in the last 7 days prior to screening Visit and represents a change from the patient’s usual behaviour

    5. MMSE score at Screening Visit ≤20

    6. Ambulatory, non-hospitalised patients

    7. Knowledgeable and reliable close relative/caregiver who will accompany the patient to all clinic Visits during the study

    8. Stable pharmacological treatment of AD as per Summary of Product Characteristics (SmPC) for at least two months prior to screening

    9. Fertile male and female* must use highly efficient contraception, from the Screening Visit until 30 days after last dose of the IMP, defined as:
    a. A method with less than 1% failure rate (e.g. permanent sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomised partner)
    OR
    b. The use of two methods of contraception (e.g. one barrier method [condom, diaphragm or cervical/vault caps] with spermicide and one hormonal contraceptive [e.g. combined oral contraceptives, patch, vaginal ring, injectable and implants])
    *Following menarche and until becoming post-menopausal unless permanently sterile. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause.

    10. Signed informed consent by patient (or legal representative, if applicable) and signed informed consent by a close relative/caregiver prior to the initiation of any study specific procedure
    1. Hombres y mujeres entre 50–85 años
    2. Diagnóstico de EA probable de acuerdo con los criterios NIA-AA (McKhann GM et al., 2011)
    3. Índice de masa corporal (IMC) de al menos 18,5 kg/m2
    4. Agitación o agresividad notables o persistentes que alteren la vida cotidiana del paciente o pongan al paciente en situaciones de peligro durante, al menos, 3 de los 7 días previos a la visita de selección y que representen un cambio con respecto a la conducta habitual del paciente
    5. Puntuación del cuestionario Mini Med (MMSE) en las visita de selección ≤ 20
    6. Pacientes ambulatorios, no hospitalizados
    7. Familiar cercano/cuidador capacitado y de confianza que pueda acompañar al paciente a todas las visitas durante el estudio
    8. Tratamiento farmacológico estable de la EA, conforme al resumen de características del producto (RCP), durante al menos los dos meses previos a la visita de selección.
    9. Desde la visita de selección hasta 30 días después de la última dosis del medicamento en investigación, los hombres y las mujeres fértiles* deben utilizar un método anticonceptivo de alta eficacia, definido como:
    a. Un método con un índice de fallo inferior al 1 % (p. ej., esterilización permanente, implantes hormonales, inyecciones de hormonas, algunos dispositivos intrauterinos o pareja vasectomizada)
    O
    b. El uso de dos métodos anticonceptivos (p. ej., un método de barrera [preservativo, diafragma o capuchón cervical] con espermicida y un anticonceptivo hormonal [p. ej., anticonceptivos orales combinados, parche, anillo vaginal, inyectable e implantes])
    * Después de la menarquia y hasta convertirse en posmenopáusica, salvo que sea permanentemente estéril. Un estado posmenopáusico se define como la ausencia de la menstruación durante 12 meses sin una causa médica alternativa
    10. Consentimiento informado firmado por el paciente (o un representante legal, en su caso) y consentimiento informado firmado por el cuidador/ familiar cercano antes del inicio de cualquier procedimiento específico del estudio
    E.4Principal exclusion criteria
    1. Failure to perform screening or baseline examinations
    2. Hospitalization or change of concomitant medication one month prior to screening Visit or during screening Period
    3. Member or immediate family of the study personnel or subordinate (or immediate family of a subordinate) to any of the study personnel
    4. Positive results for human immunodeficiency virus (HIV), active hepatitis C (positive detection of HCV RNA by nucleic acid test) or hepatitis B (hepatitis B surface antigen [HbsAg]) serology at the screening Visit, or significant medical history, signs and symptoms for tuberculosis (TB) according to the investigator criteria
    5. Clinically significant, advanced or unstable disease that may interfere with evaluation:
    a. Seizures disorders
    b. Respiratory insufficiency (partial pressure of oxygen <60 mm Hg and partial pressure of carbon dioxide <50 mmHg)
    c. Hepatic impairment (serum total bilirubin value, serum alanine aminotransferase [ALT], serum aspartate aminotransferase [AST] and gamma-glutamyl-transferase [GGT] 1.5 x upper limit of normal [ULN])
    d. Renal insufficiency (serum creatinine >2mg/dl)
    e. Heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within 6 months before Screening Visit)
    f. Non-controlled hypertension treatment
    g. Atrioventricular block (type II / Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcB-interval (males >450 msec and females >470 msec)
    h. Uncontrolled diabetes (Hb1Ac >7.5%)
    i. Haematological disorders, especially thrombocytopenia (platelets <75 000/mm3) and neutropenia (neutrophils <1 500/mm3)
    j. Malignant tumours within the last 5 years
    6. Disability that may prevent the patients from completing all study requirements; for instance, blindness, deafness, severe language difficulty
    7. Chronic drug intake of:
    a. Acenocoumarol, warfarin or digitoxin
    b. Antidepressants (other than selective serotonin reuptake inhibitors [SSRIs], selective serotonin–norepinephrine reuptake inhibitors [SSNRIs], or other noradrenergic and/or serotoninergic antidepressant - see table 2 and table 3 -) in stable dose for at least one month before Screening Visit)
    c. Antipsychotics (other than oral atypical antipsychotics in stable dose for at least one month before Screening Visit – See Table 2)
    d. Mood stabilizers (i.e. lithium or valproic acid)
    e. Systemic anticholinergics (inhaled anticholinergic are allowed)
    f. Nootropics; for instance, racetams, amphetamines, methylphenidate, levodopa, preparations containing Gingko biloba or St John′s Wort
    g. Centrally active anti-hypertensive drugs (such as clonidine, a-methyldopa, guanidine, guanfacine)
    h. Corticosteroids or immunosuppressant (only inhaled or topical suspension are allowed).
    i. MAO inhibitors
    j. Intake of medications acting directly on central nervous system that investigator considers relevant to the study
    Note:
    i) Short and medium half-life oral benzodiazepines (alprazolam, lorazepam, midazolam, oxazepam, temazepam) and Z-drugs (zaleplon, zolpidem, zoplicone) are allowed in occasional short-term prescription.
    ii) Regular intake and in stable dose of gabapentine, topiramate, pregabaline for at least one month before Screening Visit are allowed.
    8. Suspected or known drug or alcohol abuse.
    9. Enrolment in another investigational study or intake of investigational drug within the previous 3 months.
    10. Suicide attempt within the last year or significant risk of suicide (in the opinion of the investigator, defined as a “yes” to suicidal ideation questions 4 or 5, or answering “yes” to suicidal behavior on the Columbia-Suicide Severity Rating Scale within the past 12 months).
    11. Any condition that in the opinion of the investigator makes the patient unsuitable for inclusion in the study.
    1. No realización de las pruebas indicadas en la visita de selección
    2. Hospitalización o cambio de la medicación concomitante un mes antes de la visita de selección o durante el período de selección
    3. Miembro o familiar cercano de un miembro del personal del estudio o subordinado (o familiar inmediato de un subordinado) de algún miembro del personal del estudio
    4. Resultados positivos en las pruebas serológicas del virus de la inmunodeficiencia humana (VIH), del virus de la hepatitis C activo (detección positiva del ARN del VHC mediante la prueba de ácidos nucleicos) o del virus de la hepatitis B (antígeno de superficie del virus de la hepatitis B [HbsAg]) en la visita de selección, o antecedentes médicos, signos y síntomas importantes de tuberculosis (TB) de acuerdo con los criterios del investigador
    5. Enfermedad avanzada o inestable clínicamente significativa que pueda interferir con la evaluación:
    a. Trastorno convulsivos
    b. Insuficiencia respiratoria (presión parcial de oxígeno < 60 mmHg y presión parcial de dióxido de carbono < 50 mmHg)
    c. Disfunción hepática (valor de bilirrubina total en suero, alanina transaminasa [ALT] en suero, aspartato transaminasa [AST] en suero y gamma-glutamil-transferasa [GGT] 1,5 × límite superior de la normalidad [LSN])
    d. Insuficiencia renal (creatinina en suero > 2 mg/dl)
    e. Cardiopatía (infarto de miocardio, angina inestable, insuficiencia cardíaca, cardiomiopatía en los 6 meses previos a la visita de selección)
    f. Tratamiento de hipertensión no controlada
    g. Bloqueo auriculoventricular (tipo II/Mobitz II y tipo III), síndrome congénito del intervalo QT largo, disfunción del nódulo sinusal o intervalo QTcB prolongado (hombres > 450 ms y mujeres > 470 ms)
    h. Diabetes no controlada (Hb1Ac > 7,5%)
    i. Trastornos hematológicos, especialmente trombocitopenia (plaquetas < 75 000/mm3) y neutropenia (neutrófilos < 1500/mm3)
    j. Tumores malignos en los últimos 5 años
    6. Discapacidad que pueda impedir que los pacientes completen todos los requisitos del estudio; por ejemplo, ceguera, sordera, dificultad grave del lenguaje
    7. Ingesta crónica de medicamentos :
    a. Acenocoumarol, warfarina o digitoxina
    b. Antidepresivos (distintos de inhibidores selectivos de la recaptación de serotonina [ISRS], inhibidores selectivos de la recaptación de serotonina-noradrenalina [ISRSN] u otros antidepresivos noradrenérgicos y/o serotoninérgicos; consulte las tablas 2 y 3) en dosis estables durante, al menos, un mes antes de la visita de selección
    c. Antipsicóticos (distintos de los antipsicóticos atípicos orales en dosis estables durante, al menos, un mes antes de la visita de selección)
    d. Estabilizadores del estado de ánimo (p. ej., litio o ácido valproico)
    e. Anticolinérgicos sistémicos (se permiten los anticolinérgicos inhalados)
    f. Nootrópicos; por ejemplo, racetamos, anfetaminas, metilfenidato, levodopa, preparados que contienen Ginkgo biloba o hierba de San Juan
    g. Medicamentos antihipertensivos activos a nivel central (como clonidina, alfametildopa, guanidina, guanfacina)
    h. Corticoesteroides o inmunodepresores (solo se permiten los inhalados o en suspensión tópica).
    i. Inhibidores de la MAO
    j. Ingesta de medicamentos que actúan directamente en el sistema nervioso central que el investigador considere relevantes para el estudio
    Nota:
    i) Las benzodiazepinas orales de semivida corta y media (alprazolam, lorazepam, midazolam, oxazepam, temazepam) y los medicamentos Z (zaleplon, zolpidem, zoplicona) se permiten en caso de recetas ocasionales a corto plazo.
    ii) Se permite la ingesta regular y en dosis estables de gabapentina, topiramato y pregabalina durante, al menos, un mes antes de la visita de selección.
    8. Alcoholismo o toxicomanía posibles o confirmados.
    9. Participación en otro estudio de investigación o toma de un medicamento en fase de investigación en los 3 meses previos.
    10. Intento de suicidio a lo largo del último año o riesgo importante de suicidio (en opinión del investigador, definido como un “sí” a las preguntas 4 o 5 sobre ideas de suicidio, o responder “sí” a la conducta suicida en la Escala Columbia para Evaluar el Riesgo de Suicidio en los últimos 12 meses).
    11. Cualquier condición que, en opinión del investigador, haga que el paciente resulte inadecuado para su inclusión en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    1. Change from baseline to week 8 in NPI-4 A/A(i.e. the 4 item Neuropsychiatric Inventory Questionnaire Agitation/Aggression Subscale: agitation/aggression, disinhibition, irritability/lability, aberrant motor disturbance)
    2. Change over time in the NPI-4 A/A
    3. Change from baseline to week 8 in the Cohen-Mansfield Agitation inventory (CMAI)
    4. Change over time in the CMAI
    5. Change from baseline to week 8 in the Clinical Global Impression-Agitation/Aggression (CGI-A/A)
    6. Change over time in the CGI-A/A
    1. Cambio desde visita basal hasta la semana 8 en el Cuestionario del Inventario Neuropsiquiátrico (NPI-4 A/A).Es decir , las subescalas de 4 ítems de NPI A/A : Agitación/Agresividad, Desinhibición, Irritabilidad y Conducta motora anómala)
    2. Cambio a lo largo del tiempo en la NPI-4 A/A
    3. Cambio desde visita basal hasta la semana 8 en el Cuestionario de Agitación de Cohen-Mansfield (Cohen-Mansfield Agitation Inventory, CMAI)
    4. Cambio a lo largo del tiempo en el CMAI
    5. Cambio desde visita basal hasta la semana 8 en la escala de Impresión-Agitación/Agresión Clínica Global (Clinical Global Impression-Agitation/Agression, CGI-A/A)
    6. Cambio a lo largo del tiempo en la CGI-A/A
    E.5.1.1Timepoint(s) of evaluation of this end point
    13 weeks
    13 semanas
    E.5.2Secondary end point(s)
    1. Change from baseline to week 8 in NPI
    2. Change from baseline to week 8 in Zarit Burden Interview (ZBI)
    3. Change from baseline to week 8 in MMSE
    4. Number, frequency and severity of Adverse Drug Reactions (ADRs) up to week 8
    5. Number, frequency and severity of Serious ADRs up to Week 8
    6. Number and percentage of withdrawn participants due to ADRs up to Week 8
    7. Change from baseline to Week 8 in physical examination, vital signs and ECG parameters
    8. Frequency of physical examination parameters, vital signs and ECG parameters of potential clinical concern throughout the study Period
    9. Change from baseline to Week 8 in clinical laboratory parameters (hematology, including platelets) and clinical chemistry
    10. Frequency of clinical laboratory parameters (hematology and clinical chemistry) of potential clinical concern throughout the study Period
    11. Use of concomitant medication throughout the study Period
    1. Cambio desde visita basal hasta la semana 8 en el NPI
    2. Cambio desde visita basal hasta la semana 8 en la Cuestionario sobre la carga del cuidador
    (Zarit Burden Interview, ZBI)
    3. Cambio desde visita basal hasta la semana 8 en la escala Mini Mental (MMSE)
    4. Número, frecuencia e intensidad de las Reacciones Adversas a la medicación (RAs) hasta la semana 8
    5. Número, frecuencia e intensidad de las RAs graves hasta la semana 8
    6. Número y porcentaje de participantes que se retiran debido a RAs hasta la semana 8.
    7. Cambio desde visita basal hasta la semana 8 en la exploración física, las constantes vitales y los parámetros del ECG.
    8. Frecuencia de los parámetros de la exploración física, las constantes vitales y los parámetros del ECG de posible relevancia clínica durante todo el período del estudio.
    9. Cambio desde visita basal hasta la semana 8 en los parámetros clínicos de laboratorio (hematología, incluyendo las plaquetas) y en la bioquímica clínica.
    10. Frecuencia de los parámetros clínicos de laboratorio (hematología y bioquímica clínica) de posible relevancia clínica a lo largo de todo el período del estudio.
    11. Uso de medicación concomitante a lo largo de todo el período del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    13 weeks
    13 semanas
    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 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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 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
    LPLV
    LPLV
    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 months5
    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: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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
    A signed consent will be requested to the patient. If the patient is uncapable to sign a signed consent will be requested to the legal representative
    The caregiver of the patient who must accompany him on all visits, must also sign his own consent.
    Se solicitará consentimiento al paciente y si éste no puede firmar, se solicitará consentimiento al representante legal.
    El cuidador del paciente que debe acompañarlo en todas las visitas, también deberá firmar su propio 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)
    According medical practice
    Acorde a práctica clínica
    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 Decision2019-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-29
    P. End of Trial
    P.End of Trial StatusOngoing
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