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    Summary
    EudraCT Number:2020-003469-20
    Sponsor's Protocol Code Number:CL07-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:2020-11-19
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-003469-20
    A.3Full title of the trial
    A double blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial to evaluate the efficacy and safety of vafidemstat in an adult borderline personality disorder (BPD) population (PORTICO)
    Estudio en fase IIb, doble ciego, aleatorizado, controlado con placebo, adaptativo, de 14 semanas de duración, para evaluar la eficacia y seguridad de vafidemstat en una población adulta con trastorno límite de la personalidad (TLP) (Estudio PORTICO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase IIb study to evaluate the safety and efficacy of vafidemstat in an adult borderline personality disorder population
    Estudio en fase IIb para evaluar la eficacia y seguridad de vafidemstat en una población adulta con trastorno límite de la personalidad
    A.3.2Name or abbreviated title of the trial where available
    PORTICO
    PORTICO
    A.4.1Sponsor's protocol code numberCL07-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 pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressSant Ferran 74
    B.5.3.2Town/ cityCornellà de Llobregat, Barcelona
    B.5.3.3Post code08940
    B.5.3.4CountrySpain
    B.5.4Telephone number34647796923
    B.5.6E-mailsgutierrez@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 INNVAFIDEMSTAT
    D.3.9.1CAS number 1357247-95-0
    D.3.9.3Other descriptive nameVafidemstat
    D.3.9.4EV Substance CodeSUB196696
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Borderline Personality Disorder (BPD)
    Trastorno Límite de la Personalidad (TLP)
    E.1.1.1Medical condition in easily understood language
    Borderline Personality Disorder
    Trastorno Límite de la Personalidad
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10006034
    E.1.2Term Borderline personality disorder
    E.1.2System Organ Class 10037175 - Psychiatric 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 investigate the efficacy of vafidemstat in the treatment of agitation and aggression in adult BPD patients
    • To investigate the efficacy of vafidemstat in the treatment of adult BPD patients
    • Investigar la eficacia de vafidemstat en el tratamiento de la agitación y agresividad en una población adulta con trastorno límite de la personalidad (TLP)
    • Investigar la eficacia de vafidemstat en el tratamiento de una población adulta con TLP
    E.2.2Secondary objectives of the trial
    • To investigate the effect of vafidemstat in reducing the severity of BPD symptoms in adult patients
    • To evaluate the safety of vafidemstat in adult BPD patients
    • Investigar el efecto de vafidemstat en reducir la severidad de los síntomas del TLP
    • Evaluar la seguridad de vafidemstat en una población adulta con TLP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women 18-65 years of age.
    2. Subject must meet DMS-5 diagnostic criteria for BPD at least 3 months before the Screening visit. The Mini-International Neuropsychiatric Interview (MINI) will be administered at screening in order to confirm BPD diagnosis, as well as to confirm subject does not meet other relevant exclusion criteria.
    3. Agitation-Aggression Psychiatric Inventory (AAPI) subscale of > 16 (severity x frequency) summed across the four (4) items comprising the Agitation/Aggression (A/A) subscale, and the sum of the A/A Subscale severity scores > 6.
    4. Subject is known to the site or investigator and has been treated by the site or investigator for at least the last 3 months prior to the Screening visit.
    5. Stable living environment for > 6 months before the Screening visit.
    6. Body mass index (BMI) of at least 18.5 kg/m2, but no more than 30 kg/m2.
    7. Willing and able to adhere to the prohibitions, restrictions and requirements specified in this protocol.
    8. Otherwise healthy and medically stable based on medical history.
    9. Clinical and neurological examinations and laboratory tests, as well as 12-lead ECG performed during screening that confirms subject is healthy and medically stable.
    10. Able to read and write fluently and must have adequate hearing and visual acuity to complete the required testing outlined in this protocol.
    11. Outpatient consulting general practitioner or a psychiatrist/neurologist/psychologist.
    12. Subjects should be stable in their regimen of background therapy as per the Summary of Product Characteristics (SmPC) for concomitant medications at the Screening visit and they should maintain treatment throughout the study and not initiate any prohibited medications during the trial. Subjects should agree to inform their study physician of any medication changes throughout the trial.
    13. Enrolled subjects will need to maintain their pre-screening psychotherapy schedule throughout the trial duration. That is, subjects receiving psychotherapy will need to have it started at least 3 months before the Screening visit and remain in psychotherapy throughout the trial. Subjects not receiving psychotherapy should not initiate psychotherapy during the trial.
    14. Fertile male and female subjects must use highly efficient contraception, from the Screening visit until 30 days after last dose of the IMP, defined as:
    A method with less than 1% failure rate (e.g. permanent sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner)
    OR
    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])
    15. Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline.
    16. Signed informed consent by patient prior to the initiation of any study specific procedure.
    1. Adultos entre 18-65 años.
    2. Sujetos con diagnóstico confirmado según DMS-5 de TLP al menos 3 meses antes de la visita de screening. La MINI Entrevista Neuropsiquiátrica Internacional (MINI) será administrada en la visita de screening para confirmar el diagnóstico de TLP así como para asegurar que los sujetos no cumplan otros criterios de exclusión relevantes.
    3. Sub-escala del Inventario Psiquiátrico de Agitación-Agresión (AAPI) > 16 (severidad x frecuencia) sumado a través de cuatro (4) ítems que abarcan la sub-escala de Agitación/Agresión (A/A), y una suma de la puntuación en severidad > 6 de la misma escala (A/A)
    4. El centro o el investigador conocen al sujeto y éste ha sido tratado durante un mínimo de 3 meses por el centro o por el investigador antes de la visita de screening.
    5. Condiciones de vida estables durante > 6 meses antes de la visita de screening.
    6. Índice de masa corporal (BMI) de al menos 18.5 kg/m2, y no más de 30 kg/m2
    7. Dispuesto y capaz de adherirse a las prohibiciones, restricciones y requerimientos de este protocolo.
    8. Saludable y médicamente estable según su historia médica
    9. Saludable y médicamente estable según el examen clínico y neurológico, test de laboratorio, y ECG de 12 derivaciones realizados durante el periodo de screening.
    10. Capaz de leer y escribir con fluidez, con una capacidad auditiva y visual adecuadas para completar los cuestionarios y test que se listan en el protocolo.
    11. Paciente ambulatorio que consulta a su médico de atención primaria, psiquiatra/neurólogo/psicólogo.
    12. En la visita de screening, los sujetos deben estar en un régimen estable de su terapia de base con mediaciones concomitantes según ficha técnica y deben mantener este régimen a lo largo del estudio y no iniciar ninguna medicación prohibida durante el mismo. Los sujetos deben acordar informar a su médico del estudio de cualquier cambio en su mediación a lo largo del ensayo.
    13. Los sujetos que entren en el estudio deberán mantener su régimen de psicoterapia previa a la visita de screening durante toda la duración del ensayo. Estos sujetos deberán haber empezado su psicoterapia al menos 3 meses antes de la visita de screening y, por tanto, mantenerla durante todo el ensayo. Los sujetos que no estén recibiendo psicoterapia en el momento de su inclusión en este estudio no podrán iniciarla durante el estudio.
    14. Tanto hombres como mujeres en edad fértil deberán utilizar un método anticonceptivo de alta eficacia, desde la visita de screening hasta 30 días después de la última dosis de IMP, definido como:
    - 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
    - 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])
    15. Las mujeres con potencial de procreación, deberán dar negativo a un test de embarazo en las visitas de screening y basal.
    16. Consentimiento informado firmado por el participante antes del inicio de cualquier procedimiento específico del estudio.
    E.4Principal exclusion criteria
    1. DSM-5 diagnosis of Intellectual Disability, Autism Spectrum Disorder, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder (or related disorders) or Major Depressive Disorder (MDD) with psychosis.
    2. Current DSM-5 diagnosis of Conduct Disorder, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Oppositional Defiant Disorder, Paranoid Personality Disorder or Obsessive-Compulsive Disorder.
    3. Current DSM-5 diagnosis of Panic Disorder or Post-Traumatic Stress Disorder (PTSD).
    4. History of moderate or severe substance or alcohol use disorder according to DSM-5, with the exception of nicotine and caffeine, within 6-months before screening.
    5. Use of illicit drugs for at least one week before Screening and subjects unwilling to abstain from use of these substances during the study.
    6. Clinically significant, advanced or unstable disease that is likely to result in rapid deterioration of the subject’s condition or affect their safety during the study.
    7. Positive results for HIV, Hepatitis C or Hepatitis B at the screening visit
    8. Uncontrolled hypo- or hyperthyroidism at screening visit, based on laboratory parameters.
    9. Clinically significant infection within the previous 30-days
    10. Use of prohibited chronic medication*
    *The concomitant use of MAO inhibitors and antidepressants; atypical antipsychotics; mood stabilizers and nootropics in stable doses for at least 2 months before screening are allowed for the treatment of psychiatric comorbidities (as per inclusion/exclusion criteria) when these medications are prescribed as per their labelled indications
    11. Esketamine in the past 90 days before the Screening visit.
    12. Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in the past 90 days before the screening visit.
    13. Any regular intake of medications acting directly on central nervous system that investigator considers relevant to the study.
    14. Member or immediate family of the study personnel or subordinate to any of the study personnel.
    15. Enrollment in another investigational study or intake of investigational drug within the previous 3 months.
    16. Suicide attempt within the 6-month prior to the Screening visit or significant risk of suicide.
    17. Any condition that in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
    Other in- and exclusion criteria may apply.
    1. Sujetos con un diagnóstico actual o previo según DSM-5 de discapacidad intelectual, trastorno del espectro autista, esquizofrenia, trastorno esquizoafectivo, trastorno bipolar (o trastornos relacionados) o trastorno depresivo mayor (MMD) con psicosis.
    2. Sujetos con un diagnóstico actual según DSM-5 de trastorno de conducta, anorexia nerviosa, bulimia nerviosa, trastorno por atracón, trastorno de oposición desafiante, trastorno de la personalidad paranoide o trastorno obsesivo-compulsivo.
    3. Sujetos con un diagnóstico actual según DSM-5 de trastorno de pánico o trastorno de estrés postraumático (TEPT).
    4. Sujetos con un historial de trastorno por consumo de sustancias o alcohol moderado o severo de acuerdo con DSM-5, con la excepción de la nicotina y cafeína, en los 6 meses previos al screening.
    5. Uso de drogas ilícitas durante la semana previa a la visita de screening y sujetos reacios a abstenerse del uso de estas substancias durante el estudio.
    6. Enfermedad clínicamente significativa, avanzada o inestable que probablemente vaya a resultar en un deterioro rápido de la condición del sujeto o vaya a afectar a su seguridad durante el estudio.
    7. Resultado positivo de VIH, hepatitis C o hepatitis B en la visita de screening.
    8. Hipo o hipertiroidismo no controlado en la visita de screening, basado en los parámetros de laboratorio.
    9. Infección clínicamente significativa en los 30 días previos a la visita de screening.
    10. Uso de medicación crónica prohibida*
    *El uso concomitante de inhibidores MAO y antidepresivos; antipsicóticos atípicos; estabilizadores del estado de ánimo y nootrópicos en dosis estables durante al menos 2 meses antes de la visita de screening está permitido para el tratamiento de comorbilidades psiquiátricas (según los criterios de inclusión/exclusión) cuando estos medicamentos se recetan según ficha técnica
    11. Esketamina en los 90 días antes de la visita de screening
    12. Terapia electroconvulsiva (TEC) o estimulación magnética transcraneal (EMT) en los 90 días antes de la visita de screening.
    13. Cualquier ingesta regular de medicamentos que actúen directamente sobre el sistema nervioso central que el investigador considere relevante para el estudio.
    14. Miembro o familia inmediata del personal del estudio o subordinado (o familia inmediata de un subordinado) del personal del estudio.
    15. Participación en otro estudio clínico o administración de algún fármaco en investigación dentro de los 3 meses previos a la visita de screening.
    16. Intento de suicidio en los 6 meses previos a la visita de screening o riesgo significativo de suicidio
    17. Cualquier condición que, en la opinión del investigador, hace que el sujeto sea inadecuado para su inclusión en el estudio.
    Otros criterios de in- y exclusión pueden ser aplicables
    E.5 End points
    E.5.1Primary end point(s)
    Primary – Efficacy
    • To evaluate the difference on the Clinical Global Impression-Severity focused on Agitation/Aggression (CGI-S A/A) from baseline to specific week, between the active treatment arm and the placebo arm
    • To evaluate the difference on the Borderline Personality Disorder Checklist (BPDCL), from baseline to specific week, between the active treatment arm and the placebo arm
    Primarias – Eficacia
    • Evaluar la diferencia en la escala de Impresión Clínica Global de severidad centrada en la agitación/agresión (CGI-S A/A) desde la visita basal hasta una semana específica, entre el brazo de tratamiento activo y el brazo de placebo
    • Evaluar la diferencia en la Borderline Personality Disorder Checklist (BPDCL), desde la visita basal hasta una semana específica, entre el brazo de tratamiento activo y el brazo de placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to a specific week
    De la visita basal a una semana específica
    E.5.2Secondary end point(s)
    Secondary – Efficacy
    • To evaluate the change over time on the CGI-S A/A
    • To evaluate the change over time on the BPDCL
    • To evaluate the difference on the following measures, from baseline to specific week, as well as change over time, between the active treatment arm and the placebo arm:
    a) Borderline Evaluation of Severity over Time (BEST)
    b) Beck Depression Inventory – II (BDI-II)
    c) State-Trait Anger Expression Inventory 2 (STAXI-2)
    d) State-Trait Anxiety Inventory (STAI)

    Secondary – Safety
    • To evaluate the following safety endpoints throughout the study, from baseline to week 14, including:
    a) Number, frequency and severity of Treatment Emergent Adverse Events (TEAEs)
    b) Number, frequency and severity of Serious TEAEs
    c) Number and percentage of withdrawn subjects due to TEAEs
    d) Frequency of physical examination parameters, vital signs and ECG parameters of potential clinical concern throughout the study period
    e) Frequency of clinical laboratory parameters (hematology, including platelets, and clinical chemistry) of potential clinical concern throughout the study period
    f) Columbia – Suicide Severity Rating Scale (C-SSRS)
    g) Use of concomitant medication throughout the study period

    • To evaluate the change from baseline to specific week of the following safety endpoints:
    a) Physical examination, vital signs and ECG parameters
    b) Clinical laboratory parameters (hematology, including platelets, and clinical chemistry)
    Secundarias – Eficacia
    • Evaluar el cambio a lo largo del tiempo en CGI-S A/A
    • Evaluar el cambio a lo largo del tiempo en BPDCL
    • Evaluar la diferencia en las siguientes medidas, desde la visita basal hasta una semana específica, así como el cambio a lo largo del tiempo, entre los brazos de tratamiento activo y el brazo de placebo:
    a) Borderline Evaluation of Severity over Time (BEST)
    b) Beck Depression Inventory – II (BDI-II)
    c) Inventario de expresión de ira estado-rasgo - 2 (STAXI-2)
    d) State-Trait Anxiety Inventory (STAI)

    Secundarias – Seguridad
    • Evaluar las siguientes variables de seguridad a lo largo del estudio, desde la visita basal hasta la semana 14, incluyendo:
    a) Número, frecuencia y gravedad de los eventos adversos emergentes tras el inicio del tratamiento (TEAEs)
    b) Número, frecuencia y gravedad de los TEAEs graves
    c) Número y porcentaje de los sujetos retirados del estudio debido a TEAEs
    d) Frecuencia de los parámetros en el examen físico, signos vitales y parámetros del ECG de posible relevancia clínica a lo largo de todo el período de estudio
    e) Frecuencia de los parámetros clínicos de laboratorio (hematología, incluidas las plaquetas y química clínica) de relevancia clínica durante todo el período del estudio
    f) Columbia - Escala de calificación de gravedad del suicidio (C-SSRS)
    g) Uso de medicación concomitante durante todo el período de estudio

    • Evaluar el cambio desde la visita basal hasta una semana específica de las siguientes variables de seguridad:
    a) Examen físico, signos vitales y parámetros de ECG
    b) Parámetros clínicos de laboratorio (hematología, incluidas las plaquetas y química clínica)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endopoint: from baseline to a specific week
    Safety endpoints: from baseline to week 14, from baseline to a specific week
    Variable de eficacia: des de la visita basal hasta una semana específica
    Variable de seguridad: desde la visita basal a la semana 14, des de la visita basal hasta una semana específica
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Serbia
    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
    The end of study is defined as the date of the last patient last visit (LPLV), described in the protocol as last patient out (LPO)
    Último paciente-última visita (LPLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 156
    F.1.3Elderly (>=65 years) No
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 111
    F.4.2.2In the whole clinical trial 156
    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 Decision2020-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-19
    P. End of Trial
    P.End of Trial StatusOngoing
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