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    Summary
    EudraCT Number:2018-000586-37
    Sponsor's Protocol Code Number:CY5022
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-23
    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 number2018-000586-37
    A.3Full title of the trial
    A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability Of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS)
    Estudio en fase II, multicéntrico, doble ciego, aleatorizado, de búsqueda de dosis y controlado con placebo para evaluar la eficacia, la seguridad y la tolerabilidad de CK-2127107 en pacientes con esclerosis lateral amiotrófica (ELA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS)
    Evaluar el efecto, seguridad y tolerabilidad de CK-2127107 en pacientes con esclerosis lateral amiotrófica (ELA).
    A.4.1Sponsor's protocol code numberCY5022
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03160898
    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 SponsorCytokinetics, 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 supportCytokinetics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCytokinetics, Inc.
    B.5.2Functional name of contact pointMedical Affairs
    B.5.3 Address:
    B.5.3.1Street Address280 East Grand Avenue
    B.5.3.2Town/ citySouth San Francisco, CA
    B.5.3.3Post code94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650624 2929
    B.5.6E-mailmedicalaffairs@cytokinetics.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 nameReldesemtiv
    D.3.2Product code CK-2127107
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNReldesemtiv
    D.3.9.1CAS number 1345410-31-2
    D.3.9.2Current sponsor codeCK-2127107
    D.3.9.3Other descriptive nameReldesemtiv
    D.3.9.4EV Substance CodeSUB191996
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Amyotrophic Lateral Sclerosis (ALS)
    Esclerosis Lateral Amiotrófica (ELA)
    E.1.1.1Medical condition in easily understood language
    Motor Neuron Disease
    Enfermedad de la Neurona Motora
    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 PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the effect of CK-2127107 versus placebo on respiratory function in patients with ALS.
    - Evaluar el efecto de CK-2127107 en comparación con el placebo en la función respiratoria de los pacientes con ELA.
    E.2.2Secondary objectives of the trial
    • To assess the effect of CK-2127107 versus placebo on measures of skeletal muscle function
    • To assess the effect of CK-2127107 versus placebo on global function
    • To evaluate the safety and tolerability of CK-2127107 administered orally to patients with ALS
    • To evaluate the exposure of CK-2127107 and its metabolites, when administered orally in tablet form to patients with ALS in the fed state
    - Analizar el efecto de CK-2127107 en comparación con el placebo en las mediciones de la función del músculo esquelético
    - Analizar el efecto de CK-2127107 en comparación con el placebo en la función global
    - Evaluar la seguridad y la tolerabilidad de CK-2127107 administrado por vía oral a pacientes con ELA
    - Evaluar la exposición de CK-2127107 y sus metabolitos cuando se administra por vía oral en forma de comprimidos a pacientes con ELA en estado posprandial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to comprehend and willing to sign an Informed Consent Form (ICF)
    2. Males or females between the ages of 18 and 80 years of age, inclusive
    3. Diagnosis of familial or sporadic ALS (defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology El Escorial criteria published in 2000 (Brooks, Miller et al. 2000) ≤ 24 months prior to screening
    4. Upright SVC ≥ 60% of predicted for age, height and sex at screening
    5. Able to swallow tablets
    6. A caregiver (if one is needed)
    7. Able to perform reproducible pulmonary function tests
    8. Pre-study clinical laboratory findings within the normal range or, if outside the normal range, deemed not clinically significant by the Investigator
    9. Male patients, who have not had a vasectomy and a confirmed zero sperm count, must agree after receiving the first dose of study drug and until 10 weeks after the last dose to do either of the following:
    - use a condom during sexual intercourse with female partners who are of reproductive potential AND to have female partners use an additional effective means of contraception (e.g., diaphragm plus spermicide, or oral contraceptives)
    OR
    - abstain from heterosexual intercourse
    10. Female patients must be post-menopausal (≥ 1 year) OR sterilized, OR if of childbearing potential (i.e., females who have had their first period unless they are anatomically and physiologically incapable to become pregnant), must:
    • not be breastfeeding,
    • have a negative pregnancy test,
    • have no intention of becoming pregnant during the course of the study, AND do either of the following:
    - use contraceptive drugs or devices as detailed in item number 9 from Screening until 10 weeks after the last dose of study drug AND require male partners to use a condom during sexual intercourse
    OR
    - abstain from heterosexual intercourse from Screening until 10 weeks after the last dose of study drug
    11. Patients must be either on riluzole for at least 30 days prior to screening or have not taken riluzole for at least 30 days prior to screening and not planning to start riluzole during the course of the study.
    12. Patients on edaravone must have completed at least 2 cycles of dosing with edaravone at the time of screening or have not taken edaravone for at least 30 days prior to screening and not planning to start edaravone during the course of the study. Two cycles of dosing are defined as having completed Cycle 1 infusion, which is 14 consecutive days of intravenous (IV) edaravone followed by 14 days off edaravone, and Cycle 2, which is 10 out of 14 days of IV edaravone.
    1. Capacidad para comprender y voluntad para firmar el formulario de consentimiento informado (FCI)
    2. Pacientes de ambos sexos de 18 a 80 años, ambos inclusive
    3. Diagnóstico de ELA familiar o esporádica (definida por cumplir los criterios diagnósticos de ELA de posible, probable según los datos de laboratorio, probable o definitiva conforme a los criterios de El Escorial de la Federación Mundial de Neurología publicados en el año 2000 (Brooks, Miller et al. 2000) ≤24 meses antes de la selección
    4. CVL en posición erguida ≥60 % de lo pronosticado según la edad, estatura y sexo en la selección
    5. Capacidad para tragar comprimidos
    6. Un cuidador (si se necesita uno)
    7. Capacidad para realizar pruebas de función pulmonar reproducibles
    8. Datos analíticos clínicos anteriores al estudio dentro del intervalo normal, o si están fuera del intervalo normal, sin importancia clínica a juicio del investigador
    9. Los pacientes del sexo masculino no sometidos a vasectomía y sin ausencia confirmada de espermatozoides, después de recibir la primera dosis del fármaco del estudio y hasta 10 semanas después de la última dosis, deben aceptar hacer algo de lo siguiente:
    - el uso de un preservativo durante el coito con parejas del sexo femenino con capacidad para concebir Y el uso por parte de las parejas de sexo femenino de otros métodos anticonceptivos eficaces (por ejemplo, diafragma más espermicida o anticonceptivos orales)
    O BIEN
    - abstenerse de mantener relaciones sexuales
    10. Las pacientes deben estar en estado posmenopáusico (≥1 año) O esterilizadas O en caso de tener capacidad de concebir (es decir, mujeres con menarquía salvo que sean incapaces a nivel anatómico o fisiológico de quedarse embarazadas) deben:
    - no estar en periodo de lactancia,
    - presentar un resultado negativo en la prueba de embarazo,
    - no tener intenciones de quedarse embarazadas durante el transcurso del estudio, Y hacer algo de lo siguiente:
    – usar fármacos o productos anticonceptivos según lo detallado en el punto 9desde el momento de la selección hasta 10 semanas después de la última dosis del fármaco del estudio Y exigir a las parejas del sexo masculino el uso de un preservativo durante el coito
    O BIEN
    – abstenerse de mantener relaciones sexuales heterosexuales desde el momento de la selección hasta 10 semanas después de la última dosis del fármaco del estudio
    11. Los pacientes deben estar en tratamiento con riluzol al menos durante los 30 días anteriores a la selección o bien no haber tomado riluzol al menos durante los 30 días anteriores a la selección y no tener previsto el inicio de un tratamiento con riluzol durante el transcurso del estudio.
    12. Los pacientes en tratamiento con edaravona deben haber completado al menos 2 ciclos de administración de edaravona en el momento de la selección o no haber tomado edaravona al menos durante los 30 días anteriores a la selección y no tener previsto el inicio de un tratamiento con edaravona durante el transcurso del estudio. Dos ciclos de administración se definen por haber completado la infusión del ciclo 1, que consta de 14 días consecutivos de edaravona i.v. seguidos de 14 días sin tratamiento con edaravona, y el ciclo 2, que consta de 10 de los 14 días con edaravona i.v.
    E.4Principal exclusion criteria
    1. At the time of screening, any use of non-invasive ventilation, e.g. continuous positive airway pressure, noninvasive bi-level positive airway pressure or noninvasive volume ventilation, for any portion of the day, or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation
    2. Neurological impairment due to a condition other than ALS
    3. Presence at screening of any medically significant cardiac, pulmonary, gastrointestinal, musculoskeletal, or psychiatric illness that might interfere with the patient’s ability to comply with study procedures or that might confound the interpretation of clinical safety or efficacy data, including, but not limited to:
    a. A pulse <40 or >100 bpm; mean systolic blood pressure >180 mm Hg; mean diastolic blood pressure >100 mm Hg (based on measurements taken after rest for 3 minutes) that persist on 3 successive measurements taken at least 2 minutes apart.
    b. Clinically significant ECG abnormalities that require medical attention (i.e., persistent atrioventricular conduction block >first degree, or acute myocardial ischemic changes)
    c. New York Heart Association Class II or greater congestive heart failure
    d. Chronic obstructive pulmonary disease or asthma requiring daily use of bronchodilator medications
    e. Gastrointestinal disorder that is likely to impair absorption of study drug from the gastrointestinal tract
    f. ALT or aspartate aminotransferase (AST) greater than or equal to 3-times the upper limit of normal (ULN) or has total bilirubin (TBL) greater than or equal to 2-times the ULN at screening. These assessments may be repeated at the Investigator’s discretion (within the screening window).
    g. Poorly controlled or brittle diabetes mellitus
    h. Amputation of a limb
    i. Cognitive impairment, related to ALS or otherwise, sufficient to impair the patient’s ability to understand and/or comply with study procedures and provide informed consent
    j. Cancer with metastatic potential (other than basal cell carcinoma, carcinoma in situ of the cervix, or squamous cell carcinoma of the skin excised with clean margins) diagnosed and treated within the last five years
    k. Any other condition, impairment or social circumstance that, in the opinion of the Investigator, would render the patient not suitable to participate in the study
    l. Patient judged to be actively suicidal or a suicide risk by the Investigator
    m. Patient has estimated glomerular filtration rate (eGFR) less than 40 mL/min/1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin equation based on a cystatin C measurement at baseline
    4. Has taken any investigational study drug within 30 days or five half-lives of the prior agent, whichever is longer, prior to dosing
    5. Known to have received CK-2127107 or tirasemtiv in any previous clinical trial
    6. Has received or is considering receiving during the course of the study any form of stem cell therapy for the treatment of ALS
    7. Has received or is considering receiving during the course of the study any form of gene therapy for the treatment of ALS
    8. Has received or is considering obtaining during the course of the study a diaphragmatic pacing system
    9. History of substance abuse within the past 2 years
    10. Use of a strong cytochrome P450 (CYP) 3A4 inhibitor within 7 days prior to first dose of study drug or a strong CYP3A4 inducer within 14 days prior to first dose of study drug
    11. Use of a medication that is an OCT1/OCT2 substrate within 7 days
    1. En el momento de la selección, cualquier uso de respiración no invasiva, por ejemplo, presión positiva continua, presión positiva a dos niveles no invasiva o respiración controlada por volumen no invasiva en cualquier momento del día, o respiración mecánica por traqueostomía, o cualquier tipo de suministro de oxígeno
    2. Deterioro neurológico a causa de una enfermedad distinta de la ELA
    3. Presencia en la selección de alguna enfermedad de interés clínico de tipo cardíaco, pulmonar, gastrointestinal, musculoesquelético o psiquiátrico que pudiera afectar a la capacidad del paciente para cumplir con los procedimientos del estudio o que pudiera confundir la interpretación de los datos de seguridad o eficacia clínicas, entre otras:
    a. Pulso <40 o >100 lpm; presión arterial sistólica media >180 mm Hg; presión arterial diastólica media >100 mm Hg (según las mediciones tomadas tras 3 minutos de reposo) que persistan en 3 mediciones consecutivas tomadas con una separación mínima de 2 minutos.
    b. Anomalías en el ECG de importancia clínica que exijan atención médica (es decir, bloqueo auriculoventricular persistente superior al primer grado o alteraciones isquémicas miocárdicas agudas)
    c. Insuficiencia cardíaca congestiva de clase II o superior según la New York Heart Association
    d. Enfermedad pulmonar obstructiva crónica o asma que exige el uso diario de broncodilatadores
    e. Trastorno gastrointestinal que pueda interferir en la absorción del fármaco del estudio en el tubo digestivo
    f. Alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) igual o superior a 3 veces el límite superior de la normalidad (LSN) o bilirrubina total (BT) igual o superior a 2 veces el LSN en la selección. Estas evaluaciones pueden repetirse a discreción del investigador (dentro del intervalo de selección).
    g. Diabetes mellitus mal controlada o lábil
    h. Amputación de un miembro
    i. Deterioro cognitivo relacionado con la ELA o, de lo contrario, suficiente como para afectar a la capacidad del paciente para comprender o cumplir con los procedimientos del estudio y otorgar el consentimiento informado
    j. Cáncer con potencial metastásico (distinto del carcinoma basocelular, carcinoma cervicouterino in situ o carcinoma epidermoide extirpado con bordes limpios) diagnosticado y tratado en los últimos 5 años
    k. Cualquier otra enfermedad, disfunción o circunstancia social que, en opinión del investigador, volviera inadecuado al paciente para participar en el estudio
    l. Paciente con tendencias suicidas activas o en riesgo de suicidio según el investigador
    m. El paciente presenta una tasa de filtración glomerular estimada (TFGe) inferior a 40 ml/min/1,73 m2 calculada con la ecuación de la Colaboración sobre epidemiología en la enfermedad renal crónica (CDK-EPI) con cistatina según la medición inicial de cistatina C
    4. El paciente ha tomado algún fármaco experimental en los 30 días o 5 semividas del fármaco anterior, el período que sea más largo, antes de la administración
    5. Conocimiento de haber recibido CK-2127107 o tirasemtiv en un ensayo clínico anterior
    6. El paciente ha recibido o está pensando en recibir durante el transcurso del estudio cualquier tipo de tratamiento con células madre para la ELA
    7. El paciente ha recibido o está pensando en recibir durante el transcurso del estudio cualquier tipo de terapia génica para la ELA
    8. El paciente ha recibido o está pensando en obtener un sistema de electroestimulación diafragmática durante el transcurso del estudio
    9. Antecedentes de toxicomanía en los últimos 2 años
    10. Uso de algún inhibidor potente del citocromo P450 (CYP) 3A4 en los 7 días anteriores a la primera dosis del fármaco del estudio o uso de algún inductor potente del CYP3A4 en los 14 días anteriores a la primera dosis del fármaco del estudio
    11. Uso de algún medicamento que sea sustrato de OCT1/OCT2 en los últimos 7 días
    E.5 End points
    E.5.1Primary end point(s)
    The change from baseline to Visit Week 12 in the percent predicted slow vital capacity (SVC).
    Variación desde el valor inicial hasta la visita de la semana 12 en el porcentaje de la capacidad vital lenta (CVL) pronosticado.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At different time points throughout the study. Please refer to Appendix A within the study protocol for schedule of events.
    En diferentes momentos del studio. Por favor refiérase al Apéndice A del protocolo para los eventos programados.
    E.5.2Secondary end point(s)
    • Slope from baseline to Visit Week 12 in the mega-score of muscle strength measured by hand held dynamometry (HHD) and handgrip dynamometry
    • Change from baseline to Visit Week 12 in the ALS Functional Rating Scale – Revised (ALSFRS-R)
    • The incidence and severity of treatment-emergent adverse events (TEAEs)
    • Plasma concentrations of CK-2127107 at the sampled time points during the study
    - Pendiente desde el valor inicial hasta la visita de la semana 12 en la megapuntuación de la fuerza muscular medida mediante dinamometría manual (HHD) y dinamometría de prensión manual
    - Variación desde el inicio hasta la visita de la semana 12 en la Escala revisada de valoración funcional de la ELA (ALSFRS-R)
    - Incidencia y gravedad de los acontecimientos adversos surgidos durante el tratamiento (AAST)
    - Concentraciones plasmáticas de CK-2127107 en puntos temporales de muestreo del estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    At different time points throughout the study. Please refer to Appendix A within the study protocol for schedule of events.
    En diferentes momentos del studio. Por favor refiérase al Apéndice A del protocolo para los eventos programados.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic 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 trial4
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Australia
    Canada
    Ireland
    Netherlands
    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
    LVLS
    Última Visita del Último paciente
    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 months4
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days6
    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: 306
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 139
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 445
    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)
    After completion of the study, subjects will continue to receive treatment for their primary condition at the discretion of his/her doctor.
    Después de completar el estudio, los pacientes continuaran recibiendo tratamiento para su condición primaria segun el criterio de su doctor/doctora
    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 Decision2018-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-07
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