Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43424   clinical trials with a EudraCT protocol, of which   7183   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-000350-26
    Sponsor's Protocol Code Number:CL09-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:2021-07-30
    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 number2021-000350-26
    A.3Full title of the trial
    A double blind, randomized, placebo-controlled, adaptive 24-week Phase IIb trial to evaluate the efficacy of vafidemstat in negative symptoms and cognitive impairment associated with schizophrenia. (EVOLUTION study).
    Estudio de fase IIb, doble ciego, aleatorizado, controlado con placebo, adaptativo, de 24 semanas de duración, para evaluar la eficacia de vafidemstat en síntomas negativos y deterioro cognitivo asociado a la esquizofrenia. (Estudio EVOLUTION).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical trial to evaluate the efficacy of vafidemstat in negative symptoms and cognitive impairment associated with schizophrenia. (EVOLUTION study).
    Ensayo clínico para evaluar la eficacia de vafidemstat en síntomas negativos y deterioro cognitivo asociado a la esquizofrenia. (Estudio EVOLUTION).
    A.4.1Sponsor's protocol code numberCL09-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 pointSonia Gutierrez
    B.5.3 Address:
    B.5.3.1Street AddressSant Ferrán, 74
    B.5.3.2Town/ cityCornellá de Llobregat
    B.5.3.3Post code08940
    B.5.3.4CountrySpain
    B.5.4Telephone number+34647796923
    B.5.6E-mailsgutierrez@oryzon.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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.3.9.4EV 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
    Schizophrenia
    Esquizofrenia
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    Esquizofrenia
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    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 assess the effect of vafidemstat on negative symptoms of schizophrenia in adult patients
    •To assess the effect of vafidemstat on cognitive impairment associated with schizophrenia (CIAS) in adult patients
    • Investigar la eficacia de vafidemstat en el tratamiento de los síntomas negativos de la esquizofrenia en pacientes adultos
    • Investigar la eficacia de vafidemstat en el tratamiento del deterioro cognitivo asociado a la esquizofrenia en pacientes adultos
    E.2.2Secondary objectives of the trial
    •To assess the effect of vafidemstat on positive symptoms of schizophrenia in adult patients
    •To assess the effect of vafidemstat on functional impairment in adult schizophrenia patients
    •To evaluate vafidemstat safety in adult schizophrenia patients
    •To evaluate the effect of vafidemstat on the use of health care services in adult schizophrenia patients
    •To evaluate the effect of vafidemstat on the stable background antipsychotic medication in adult schizophrenia patients.
    • Investigar el efecto de vafidemstat en los síntomas negativos de la esquizofrenia en pacientes adultos
    • Investigar el efecto de vafidemstat en el deterioro funcional en pacientes adultos con esquizofrenia
    • Evaluar la seguridad de vafidemstat en pacientes adultos con esquizofrenia
    • Investigar el efecto de vafidemstat en la utilización de los servicios de salud en pacientes adultos con esquizofrenia
    • Evaluar el efecto de vafidemstat en la medicación estable de base con antipsicóticos en pacientes adultos con esquizofrenia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subject 18-50 years of age.
    2. The participant has schizophrenia, according to DSM-5™ as confirmed by the Mini International Neuropsychiatric Interview (MINI) Version 7.0.2 at Screening.
    3. Documented DSM-5™ diagnostic criteria for schizophrenia greater than one (1) year, but less than five (5) years from Screening.
    4. The participant has persistent, predominant negative symptoms (PNS) of schizophrenia, and minimal positive symptoms.
    5. Subject is stable in terms of positive and negative symptoms of schizophrenia over the last 2 months.
    6. The participant is currently an outpatient and has not been hospitalized within the last 2 months for an acute exacerbation of their schizophrenia or symptom worsening. In addition, the subject’s treatment must be stable and include no more than one atypical antipsychotic.
    7. Stable in their regimen of background therapy other than for psychiatric indications, as per the Summary of Product Characteristics (SmPC) for concomitant medications at the Screening visit.
    8. Body mass index (BMI) of at least 18.5 kg/m2, but no more than 35 kg/m2.
    9. Subject is considered by the investigator to be reliable and willing and able to adhere to the prohibitions, restrictions and requirements specified in this protocol.
    10. Otherwise, healthy and medically stable based on medical history.
    11. Able to read and write fluently and must have adequate hearing and visual acuity to complete the required testing outlined in this protocol.
    12. Negative Covid-19 test (PCR, antigen test or serology) at Screening (only applicable if Covid-19 precautions are still in force by the time of the Screening Visit).
    13. The subject has a study partner/caregiver who, in the investigator’s judgement, has frequent and sufficient contact with the subject.
    14. The subject has a stable living environment for > 6 months before the Screening visit, as confirmed by study partner/caregiver.
    15. Fertile male and female subjects must use highly efficient contraception, from the Screening visit until 30 days after last dose of the IMP.
    16. Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline.
    17. Signed informed consent by the subject and the subjects´ study partner/caregiver
    1. Hombre o mujer entre 18-50 años.
    2. El participante tiene diagnóstico de esquizofrenia según DMS-5 confirmado por la Entrevista Neuropsiquiátrica Internacional (MINI) versión 7.0.2 que se administra en la visita de screening.
    3. Criterio diagnóstico de esquizofrenia según DMS-5 documentado de más de un (1) año y de menos de cinco (5) años desde la visita de screening.
    4. El participante tiene predominantemente síntomas negativos (PNS) de esquizofrenia persistentes, con mínimos síntomas positivos
    5. En los últimos 2 meses, ha estado estable en cuanto a síntomas negativos y positivos de esquizofrenia
    6. El participante es en este momento un paciente ambulatorio que no ha sido hospitalizado en los últimos 2 meses por una exacerbación aguda de la esquizofrenia o un empeoramiento de los síntomas.
    7. Debe ser estable y no incluir más de un antipsicótico En la visita de screening, si el sujeto está recibiendo otra medicación concomitante además de la medicación antipsicótica, el sujeto debe estar en un régimen estable según ficha técnica,
    8. Índice de masa corporal (BMI) de al menos 18.5 kg/m2, pero no más de 35 kg/m2.
    9. Dispuesto y capaz de adherirse a las prohibiciones, restricciones y requerimientos de este protocolo.
    10. Al margen de la esquizofrenia, el sujeto presenta buena salud y está médicamente estable según su historial médico.
    11. Capaz de leer y escribir con fluidez, con una capacidad auditiva y visual adecuadas para completar los cuestionarios y test que se especifican en este protocolo.
    12. Resultado negativo en la prueba de COVID-19 (PCR, test de antígenos o serología) en la visita de screening (solo si las precauciones de COVID-19 siguen siendo obligatorias en el momento de la visita de screening.
    13. El sujeto cuenta con un responsable/cuidador que, a juicio del investigador, tiene contacto frecuente y suficiente con el mismo
    14. Condiciones de vida estables durante más de 6 meses antes de la visita de screening, confirmado por su responsable/cuidador.
    15. Tanto hombres como mujeres en edad fértil deberán utilizar un método anticonceptivo de eficacia alta, desde la visita de screening hasta 30 días después de la última dosis de IMP
    16. Las mujeres con potencial de procreación deberán tener una prueba de embarazo en orina negativa en las visitas de screening y basal.
    17. Consentimiento informado firmado por el participante y su responsable/cuidador.
    E.4Principal exclusion criteria
    1. Failure to perform screening or baseline procedures.
    2. Inadequate response in the level of psychotic symptoms during more than one documented treatment trial with an adequate dose of an antipsychotic drug prescribed for an adequate time (i.e., at least lasting for 6 weeks) within 2 years prior to the Screening Visit.
    3. Any current diagnosis of psychiatric disorder other than schizophrenia.
    4. DSM-5 diagnosis of neurodevelopmental disorders.
    5. Current DSM-5 diagnosis of conduct disorders.
    6. Current DSM-5 diagnosis of panic disorder or post-traumatic stress disorder (PTSD).
    7. Current diagnosis or a history of substance use disorder according to DSM-5™ criteria within 6 months prior to the Screening Visit.
    8. Use of illicit drugs for at least one week before Screening and subjects unwilling to abstain from use of these substances during the study.
    9. Suicide attempt or significant risk of suicide within 6-months prior to the Screening visit or the period between Screening and Baseline visit, defined as a “yes” to suicidal ideation questions 4 or 5, or answering “yes” to suicidal behavior on the Columbia-Suicide Severity Rating Scale.
    10. The subject has started formal cognitive or behavioral therapy or systematic psychotherapy within 3 months prior to Screening or plans to start such therapy during the study.
    11. The subject has a previous or current diagnosis of neuroleptic malignant syndrome.
    12. The subject has been treated with and is resistant to clozapine according to the investigator’s judgement.
    13. Hospitalization or medication change for any reason 2 months prior to the Screening visit or during the Screening period that makes the subject medically or mentally unsuitable for trial participation.
    14. 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.
    15. Positive results for tuberculosis, Human Immunodeficiency Virus (HIV), Hepatitis C or Hepatitis B serology obtained at the Screening Visit.
    16. Uncontrolled hypo- or hyperthyroidism at Screening Visit, based on laboratory parameters.
    17. Clinically significant infection within the previous 30-days (e.g., persistent or acute infection such as a urinary tract infection or upper respiratory infection).
    18. Chronic drug intake of specific forbidden medication as described in the clinical study protocol.
    19. Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in the past 3 months before the screening visit, and no use of these treatments is allowed throughout the trial.
    20. Any regular intake of medications acting directly on central nervous system that investigator considers relevant to the study.
    21. Member or immediate family of the study personnel or subordinate to any of the study personnel.
    22. Enrollment in another investigational study or intake of investigational drug within the previous 3 months.
    23. Any condition that in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
    1. Incumplimiento en la realización de los procedimientos de screening o basales.
    2. Respuesta inadecuada a nivel de síntomas psicóticos documentada durante más de un intento de tratamiento con una dosis adecuada de un fármaco antipsicótico prescrito durante un tiempo también adecuado (a saber, por lo menos de 6 semanas de duración) en los dos últimos años antes de la visita de screening.
    3. Cualquier diagnóstico actual de trastorno psiquiátrico que no sea esquizofrenia.
    4. Diagnóstico de trastornos neurológicos del desarrollo según DSM-5,
    5. Diagnóstico actual de trastornos de conducta según DSM-5,
    6. Diagnóstico actual según DSM-5 de trastorno de pánico o trastorno por estrés postraumático (TEPT).
    7. Diagnóstico actual o historial de trastorno por consumo de sustancias según criterios de DSM-5 durante los 6 meses previos a la visita de screening.
    8. Uso de drogas ilegales durante la semana previa a la visita de screening y sujetos que no estén dispuestos a abstenerse del uso de estas substancias durante el estudio.
    9. Intento de suicidio o riesgo significativo de suicidio en los 6 meses previos a la visita de screening o el periodo entre la visita de screening y la visita basal, definido como responder "sí" a las preguntas de ideas o pensamientos suicidas 4 o 5, o responder "sí" al comportamiento suicida en la escala de Clasificación de Gravedad del Suicidio de Columbia (C-SSR).
    10. El sujeto ha empezado formalmente terapia cognitiva o conductual o psicoterapia sistemática durante los 3 meses previos a la visita de screening o tiene planes de empezar este tipo de terapia durante el ensayo.
    11. El sujeto tiene un diagnóstico previo o actual de síndrome maligno neuroléptico.
    12. El sujeto ha sido tratado con clozapina y, a juicio del investigador, es resistente este fármaco.
    13. Hospitalización o cambio de medicación dos meses antes de la visita de screening o durante el período de screening que hace que el sujeto no sea considerado medicamente o mentalmente apto para participar en el ensayo.
    14. 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
    15. Resultado positivo de tuberculosis, VIH, hepatitis C o hepatitis B en la visita de screening.
    16. Hipo o hipertiroidismo no controlado en la visita de screening, basado en los parámetros de laboratorio.
    17. Infección clínicamente significativa (p. ej., infección persistente o aguda como una infección del tracto urinario o infección de las vías respiratorias superiores) en los 30 días previos a la visita de screening.
    18. Ingesta de Medicación crónica de medicación prohibida específica como se describe en el protocolo del ensayo clínico.
    19. Terapia electroconvulsiva (TEC) o estimulación magnética transcraneal (EMT) en los últimos 3 meses antes de la visita de screening. El uso de estos tratamientos no está permitido durante el estudio.
    20. Cualquier ingesta regular de medicamentos que actúen directamente sobre el sistema nervioso central que el investigador considere relevante para el estudio.
    21. Miembro o familia inmediata del personal del estudio o subordinado (o familia inmediata de un subordinado) del personal del estudio.
    22. Participación en otro estudio clínico o administración de algún fármaco en investigación en los 3 meses previos a la visita de screening.
    23. Cualquier condición que, en la opinión del investigador, hace que el sujeto no sea apto para su inclusión en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    • To evaluate the change from baseline to week 24 on the PANSS Factor Score for Negative Symptoms (PANSS-FSNS)
    • To evaluate the change from baseline to week 24 on the Brief Assessment in Cognition in Schizophrenia (BACS)
    • Evaluar la diferencia en el Factor de Puntuación para Síntomas Negativos de la escala del Síndrome Positivo y Negativo de la Esquizofrenia (PANSS-FSNS, siglas en inglés) desde la visita basal hasta la semana 24
    • Evaluar la diferencia en la escala de Evaluación Breve de la Cognición en Esquizofrenia (BACS, siglas en inglés) desde la visita basal hasta la semana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semanas
    E.5.2Secondary end point(s)
    • To evaluate the change over time on the PANSS Factor Score for Negative Symptoms (FSNS)
    • To evaluate the change over time on the BACS
    • To evaluate the difference from baseline to week 24, as well as change over time on the following:
    a) PANSS – Positive Symptoms Scale
    b) Clinical Global Impression – Severity (CGI-S) for Negative Symptoms
    c) Personal and Social Performance Scale (PSP)
    To evaluate the following safety endpoints throughout the study, from baseline to week 28:
    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) Use of concomitant medications
    e) Frequency of physical examination parameters, vital signs, and ECG parameters of potential clinical concern
    f) Frequency of clinical laboratory parameters of potential clinical concern
    g) Columbia – Suicide Severity Rating Scale (C-SSRS)
    • Evaluar el cambio a lo largo del tiempo en la PANSS-FSNS
    • Evaluar el cambio a lo largo del tiempo en la BACS
    • Evaluar la diferencia en las siguientes medidas, desde la visita basal hasta la semana 24, así como el cambio a lo largo del tiempo:
    a) Subescala de síntomas positivos del Síndrome Positivo y Negativo de la Esquizofrenia (PANSS-PSS, siglas en inglés)
    b) Escala de Impresión Clínica Global – Gravedad (CGI-S, siglas en inglés) para los Síntomas Negativos
    c) Escala de Funcionamiento Personal y Social (PSP, siglas en inglés)
    • Evaluar las siguientes variables de seguridad a lo largo del estudio, desde la visita basal hasta la semana 28:
    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 que deben abandonar el estudio debido a los TEAEs
    d) Uso de medicaciones concomitantes
    e) Frecuencia de los parámetros del examen físico, signos vitales y de los parámetros del ECG con posible relevancia clínica
    f) Frecuencia de los parámetros clínicos de laboratorio (hematología, incluidas las plaquetas, y bioquímica clínica) con posible relevancia clínica
    g) Columbia - Escala de calificación de gravedad del suicidio (C-SSRS, siglas en inglés)
    E.5.2.1Timepoint(s) of evaluation of this end point
    24-28 weeks
    24-28 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 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 concerned7
    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 months20
    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: 100
    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 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 state100
    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 clinical practice
    Acorde a la 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 Decision2021-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-02
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA