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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    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:2019-001181-15
    Sponsor's Protocol Code Number:FIS-002-2019
    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:2019-10-29
    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 number2019-001181-15
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 24-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Subjects with Facioscapulohumeral Muscular Dystrophy (FSHD)
    Estudio en fase II, aleatorizado, doble ciego, controlado con placebo de 24 semanas, en grupos paralelos sobre la eficacia y la seguridad de losmapimod en el tratamiento de pacientes con distrofia muscular fasciescapulohumeral (DFEH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Losmapimod in Patients with FSHD
    Seguridad y Eficacia de Losmapimod en pacientes con DFEH
    A.4.1Sponsor's protocol code numberFIS-002-2019
    A.5.4Other Identifiers
    Name:INDNumber:138739
    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 SponsorFulcrum Therapeutics, Inc.
    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 supportFulcrum Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFulcrum Therapeutics, Inc.
    B.5.2Functional name of contact pointMedical Doctor
    B.5.3 Address:
    B.5.3.1Street Address26 Landsdowne Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900834 223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 nameLosmapimod
    D.3.2Product code FTX-1821
    D.3.4Pharmaceutical form 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 INNLOSMAPIMOD
    D.3.9.2Current sponsor codeFTX-1821
    D.3.9.4EV Substance CodeSUB189237
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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 placeboTablet
    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
    Facioscapulohumeral Muscular Dystrophy
    Distrofia Muscular Fasciescapulohumeral
    E.1.1.1Medical condition in easily understood language
    Muscular Disease
    Enfermedad Muscular
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10064087
    E.1.2Term Facioscapulohumeral muscular dystrophy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of losmapimod in inhibiting or reducing expression of DUX4, the root cause of FSHD, as measured by a subset of DUX4-regulated gene transcripts in skeletal muscle biopsies from FSHD subjects.
    El objetivo principal de este estudio es evaluar la eficacia de losmapimod para inhibir o reducir la expresión de DUX4, causa principal de la DFEH, medida mediante un subgrupo de transcritos génicos regulados por DUX4 en biopsias de músculo esquelético de pacientes con DFEH.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • To evaluate the safety and tolerability of losmapimod in FSHD subjects
    • To evaluate the plasma concentrations of losmapimod and its metabolite GSK198602 in FSHD subjects
    • To evaluate the levels of losmapimod and GSK198602 in skeletal muscle in FSHD subjects
    • To evaluate losmapimod target engagement in blood and in skeletal muscle in FSHD subjects
    Los Objetivos secundarios del estudio son:
    • Evaluar la seguridad y la tolerabilidad de losmapimod en pacientes con DFEH.
    •Evaluar las concentraciones plasmáticas de losmapimod y su metabolito GSK198602 en pacientes con DFEH.
    •Evaluar las concentraciones de losmapimod y GSK198602 en el músculo esquelético de pacientes con DFEH.
    •Evaluar la actuación de losmapimod sobre la diana en sangre y músculo esquelético en pacientes con DFEH.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capable of understanding the written informed consent, and providing signed, dated, and witnessed written informed consent.
    2. Male or female subjects between the ages of 18 and 65 years, inclusive.
    3. Confirmed diagnosis of FSHD1 with 1 to 9 repeats via assessment of the size of the D4Z4 array on chromosome 4 using the calculator provided by the sponsor. Randomization will be stratified to ensure that treatment allocation is balanced across FSHD repeat number categories (ie, 1 to 3 repeats versus 4 to 9 repeats). Genetic confirmation must be obtained prior to the screening MRI and baseline muscle biopsy; genetic confirmation can come from previous testing if verified with appropriate documentation. Due to stable transmission of repeat sizes within families, subjects with a clinical diagnosis of FSHD who have a first-degree relative with a genetically confirmed diagnosis of FSHD1 may be entered into the study for screening and MRI. During screening, a confirmatory genetic diagnosis is conducted. If genetic testing during screening is necessary, the 4-week screening window will not start until the results are obtained and verified by the principal investigator.
    4. Clinical severity score of 2 to 4 (RICCI score; range 0-5), inclusive, at screening.
    5. Has a MRI-eligible muscle for biopsy, as determined by a central reader.
    6. Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
    7. Willing to practice an approved method of birth control:
    • A female subject is eligible to participate if she is of non-child-bearing potential, defined as premenopausal females with permanent sterilization (includes hysterectomy, bilateral oophorectomy, or bilateral salpingectomy in a female subject of any age); or postmenopausal, defined as 12 months of spontaneous amenorrhea; or, if of child-bearing potential, if she is using a highly effective method for avoidance of pregnancy and will continue to use these methods for the duration of the study and until 90 days after the last dose of study drug. The decision to include or exclude women of child-bearing potential may be made at the discretion of the investigator and in accordance with local practice in relation to adequate contraception.
    • Male subjects must agree to use a contraception method. This criterion must be followed for the duration of the study and until 90 days after the last dose of study drug.
    1. Capacidad para entender el consentimiento informado por escrito y para otorgar el consentimiento informado por escrito firmado, fechado y ante testigos.
    2. Varones o mujeres de 18 a 65 años, ambos inclusive.
    3. Diagnóstico confirmado de DFEH1 con 1 a 9 repeticiones en el cromosoma 4 mediante la evaluación del tamaño de la matriz D4Z4 utilizando el sistema de cálculo proporcionado por el promotor. La aleatorización se estratificará para garantizar que la asignación de los tratamientos esté equilibrada entre las categorías de números de repetición en la DFEH (es decir, 1 a 3 repeticiones frente a 4 a 9 repeticiones). Deberá obtenerse confirmación genética antes de la RM de selección y de la biopsia muscular basal; la confirmación genética puede proceder de pruebas previas si se verifica con la documentación apropiada. Debido a la transmisión estable de tamaños de repeticiones dentro de las familias, los pacientes con un diagnóstico clínico de DFEH que tengan un familiar de primer grado con un diagnóstico de DFEH1 confirmado genéticamente podrán ser incluidos en el estudio para la selección y la RM. Durante la selección se realizará un diagnóstico genético de confirmación. Si es necesario realizar pruebas genéticas durante la selección, el margen de 4 semanas para la selección no comenzará hasta que el investigador principal obtenga y verifique los resultados.
    4. Puntuación de gravedad clínica de 2 a 4 (puntuación RICCI; intervalo 0-5), ambos inclusive, en la selección.
    5. Músculo apto para biopsia en la RM, según la determinación de un evaluador central.
    6. Disposición y capacidad para cumplir las visitas programadas, el plan de tratamiento, las restricciones del estudio, las pruebas analíticas, las directrices sobre métodos anticonceptivos y otros procedimientos del estudio.
    7. Disposición a utilizar un método anticonceptivo aprobado:
    • Las mujeres podrán participar si no tienen capacidad reproductiva, lo que se define como mujeres premenopáusicas con esterilización permanente (histerectomía, ovariectomía bilateral o salpingectomía bilateral en mujeres de cualquier edad) o mujeres posmenopáusicas, es decir, con 12 meses de amenorrea espontánea; o, en caso de que tengan capacidad reproductiva, si utilizan un método altamente eficaz para evitar el embarazo y continúan utilizando estos métodos durante todo el estudio y hasta 90 días después de la última dosis del fármaco del estudio. La decisión de incluir o excluir a las mujeres con capacidad reproductiva la tomará el investigador según su criterio y respetando la práctica local en relación con el uso de anticonceptivos adecuados.
    • Los varones deberán aceptar el uso de un método anticonceptivos. Este criterio deberá seguirse durante todo el estudio y hasta 90 días después de la última dosis del fármaco del estudio.
    E.4Principal exclusion criteria
    1. Has a history of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. This may include, but is not limited to, a history of relevant drug or food allergies; history of cardiovascular or central nervous system disease; neuromuscular diseases except FSHD (eg, myopathy, neuropathy, neuromuscular junction disorders); or clinically significant history of mental disease.
    2. Previously diagnosed cancer that has not been in complete remission for at least 5 years. Localized carcinomas of the skin and carcinoma in situ of the cervix that have been resected or ablated for cure are not exclusionary.
    3. For subjects who are on drug(s) or supplements that may affect muscle function, as determined by the treating physician: subjects must be on a stable dose of that drug(s) or supplement for at least 3 months prior to the first dose of study drug and remain on that stable dose for the duration of the study. Changes to the dose or treatment discontinuation during the study can only be done for strict medical reasons by the treating physician with clear documentation and notification to the sponsor.
    4. History of febrile illness within 5 days before randomization. Subjects who were healthy during screening but develop febrile illness in the 5 days before randomization need to have the baseline visit postponed until the febrile illness is fully resolved. Once the febrile illness is fully resolved, the subject’s baseline visit can be scheduled. The duration of the screening visit in such cases can be extended for up to 35 days.
    5. Known active tuberculosis, active opportunistic, or life-threatening infections.
    6. Acute or chronic history of liver disease or known to have current alanine aminotransferase >=2 × upper limit of normal (ULN) or total bilirubin >=1.5 × ULN, or known history of hepatitis B or C.
    7. Known severe renal impairment (defined as a glomerular filtration rate of <30 mL/min/1.73m2).
    8. Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or antibodies against human immunodeficiency virus (HIV)-1 and -2.
    9. Standard 12-lead ECG demonstrating QTcF >450 msec for male subjects or QTcF >470 msec for female subjects at screening. If QTcF exceeds 450 msec for males or 470 msec for females, the ECG will be repeated 2 more times, and the average of the 3 QTcF values will be used to determine the subject’s eligibility.
    10. History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) or history or evidence of abnormal ECGs that, in the opinion of the investigator or medical monitor, would preclude the subject’s participation in the study.
    11. Blood donation (of approximately 1 pint [500 mL] or more) or any significant loss of blood within 90 days before the first dose of study drug, as determined by the investigator.
    12. Vaccination with a live attenuated vaccine within 6 weeks of randomization.
    1. Antecedentes de cualquier enfermedad o trastorno clínico que, en opinión del investigador, pudiera confundir los resultados del estudio o suponer un riesgo adicional para la administración del fármaco del estudio al paciente. Esto puede incluir, entre otros, antecedentes de alergias farmacológicas o alimentarias importantes, antecedentes de enfermedades cardiovasculares o del sistema nervioso central, enfermedades neuromusculares excepto DFEH (p. ej., miopatía, neuropatía, trastornos de la unión neuromuscular) o antecedentes clínicamente significativos de enfermedad mental
    2. Cáncer diagnosticado previamente que no haya estado en remisión completa durante al menos 5 años. No son motivo de exclusión los carcinomas de piel localizados y el carcinoma in situ de cuello uterino que se hayan resecado o extirpado para su curación
    3. En el caso de pacientes que estén tomando fármacos o suplementos que puedan afectar a la función muscular, según la determinación del médico responsable del tratamiento: los pacientes deberán estar recibiendo una dosis estable de ese fármaco o suplemento durante al menos los 3 meses previos a la primera dosis del fármaco del estudio y mantener dicha dosis estable durante todo el estudio. Solo el médico responsable del tratamiento podrá modificar la dosis o suspender el tratamiento durante el estudio por motivos médicos estrictos, con documentación clara y notificación al promotor
    4. Antecedentes de enfermedad febril en los 5 días previos a la aleatorización. Deberá posponerse la visita basal de los pacientes que estuvieran sanos durante la selección pero que presenten una enfermedad febril en los 5 días previos a la aleatorización hasta que la enfermedad febril se resuelva por completo. Una vez resuelta, podrá programarse la visita basal del paciente. En estos casos, el margen para la visita de selección podrá ampliarse hasta 35 días
    5. Tuberculosis activa conocida, infecciones oportunistas activas o potencialmente mortales
    6. Antecedentes de enfermedad hepática aguda o crónica o concentraciones en ese momento de alanina aminotransferasa>=2 veces el límite superior de la normalidad (LSN) o bilirrubina total >=1,5 veces el LSN o antecedentes conocidos de hepatitis B o C.
    7. Insuficiencia renal grave conocida (definida como una filtración glomerular <30 ml/min/1,73 m2).
    8. Detección positiva del antígeno de superficie del virus de la hepatitis B (HBsAg), anticuerpos contra el virus de la hepatitis C (VHC) o anticuerpos contra el VIH 1 y 2
    9. ECG de 12 derivaciones convencional que muestre un intervalo QTcF > 450 ms en varones o QTcF > 470 ms en mujeres en la selección. Si el intervalo QTcF supera los 450 ms en los varones o los 470 ms en las mujeres, se repetirá el ECG dos veces más y se utilizará el promedio de los 3 valores del QTcF para determinar la elegibilidad del paciente.
    10. Antecedentes de arritmias cardíacas con necesidad de tratamiento antiarrítmico o antecedentes o signos de anomalías en el ECG que, en opinión del investigador o del monitor médico, impidan la participación del paciente en el estudio.
    11. Donación de sangre (>=500 ml) o cualquier pérdida importante de sangre en los 90 días previos a la primera dosis del fármaco del estudio, según la determinación del investigador.
    12. Vacunación con una vacuna de microorganismos vivos atenuados en las 6 semanas previas a la aleatorización.
    13. Uso de anticoagulantes durante al menos 1 mes y de antiagregantes plaquetarios durante al menos 1 semana antes de la biopsia basal
    14. Varones cuya pareja tenga previsto quedarse embarazada durante el estudio o en los 90 días siguientes a la última dosis del fármaco del estudio
    15. Prueba de embarazo positiva o conocimiento de que la paciente está embarazada o en período de lactancia
    16. Consumo de alcohol, analgésicos/opiáceos o drogas en los 6 meses previos a la selección o una prueba positiva para drogas en la selección
    17. Cualquier trastorno mental actual que, en opinión del investigador, pueda afectar al cumplimiento del estudio o dificultar la comprensión de los objetivos, los procedimientos de investigación o las posibles consecuencias del estudio
    18.Uso de otro producto en investigación en los 30 días anteriores o el periodo equivalente a 5 semividas (lo que suponga más tiempo), o según la normativa local, o participación actual en un estudio con un producto en investigación
    19.Imposibilidad prevista de cumplir alguno de los procedimientos del estudio
    20.Resultados analíticos anómalos indicativos de cualquier enfermedad médica que, en opinión del investigador, impida la participación del paciente en el estudio
    21.El paciente, o un familiar cercano, es el investigador o un subinvestigador, asistente de investigación, farmacéutico, coordinador del estudio u otro miembro del personal directamente implicado en la realización del estudio en ese centro
    22.Contraindicación para biopsia con aguja
    23.Contraindicación para RM según la práctica clínica habitual
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the change from baseline in DUX4 activity in affected skeletal muscle at 16 weeks, as measured by QRT-PCR in a panel of DUX4-regulated gene transcripts.
    El objetivo principal de este estudio es el cambio desde evaluar la eficacia de losmapimod en la inhibición o reducción de la expresión de DUX4, la causa principal de la DFEH, determinada mediante un subgrupo de transcritos génicos regulados por DUX4 en biopsias de músculo esquelético de pacientes con DFEH.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Semana 16
    E.5.2Secondary end point(s)
    • Adverse events, SAEs, laboratory tests, ECGs, vital signs, and physical examinations
    • Plasma concentrations of losmapimod and its metabolite GSK198602
    • Concentrations of losmapimod and its metabolite in skeletal muscle biopsy at steady state
    • Target engagement parameters in blood and skeletal muscle biopsy
    •Acontecimientos Adversos, AAGs, pruebas de laboratorio, constantes vitales y examenes físicos
    •Concentraciones plasmáticas de losmapimod y su metabolito GSK198602
    •Concentraciones de losmapimod y GSK198602 en la biopsia del músculo esquelético en estado estable
    •Parámetros de unión a diana en sangre y en biopsia de músculo esquelético
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    A lo largo del estudio
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 concerned2
    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
    France
    Germany
    Spain
    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 the study is defined as the date on which the last subject completes the last visit (includes the safety follow-up visit).
    El final del estudio se define como la fecha en la cual el último paciente complete la última visita (incluyendo la visita de seguimiento de seguridad)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days7
    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: 56
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 66
    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)
    None
    Ninguno
    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 Decision2019-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-24
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA