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    Summary
    EudraCT Number:2016-003927-45
    Sponsor's Protocol Code Number:SENS-111-201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-07-05
    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 number2016-003927-45
    A.3Full title of the trial
    A multicentre, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 2 dose regimens of orally administered SENS-111 (100mg and 200mg) given during 4 days in patients suffering from Acute Unilateral Vestibulopathy
    Estudio multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de 2 pautas posológicas de SENS-111 (100 mg y 200 mg) administradas por vía oral durante 4 días en pacientes que padecen de vestibulopatía unilateral aguda (VUA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety & efficacy of SENS-111 in patients with acute vertigo due to inner ear disease
    Seguridad y eficacia de SENS-111 en pacientes con vértigo agudo debido a enfermedad del oído interno
    A.4.1Sponsor's protocol code numberSENS-111-201
    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 SponsorSensorion SA
    B.1.3.4CountryFrance
    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 supportSensorion SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSensorion SA
    B.5.2Functional name of contact pointJudith LAREDO
    B.5.3 Address:
    B.5.3.1Street Address375 rue du professeur blayac
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post code34080
    B.5.3.4CountryFrance
    B.5.4Telephone number+33467207730
    B.5.5Fax number+33499545884
    B.5.6E-mailjudith.laredo@sensorion-pharma.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 nameSENS-111
    D.3.2Product code SENS-111
    D.3.4Pharmaceutical form Orodispersible 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 INNNot yet assigned
    D.3.9.1CAS number 1164115-89-2
    D.3.9.2Current sponsor codeSENS-111
    D.3.9.3Other descriptive nameSENS-111
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboOrodispersible 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
    Acute Unilateral Vestibulopathy
    Vestibulopatía unilateral aguda
    E.1.1.1Medical condition in easily understood language
    Severe acute vertigo due to inner ear disease
    Vértigo agudo severo debido a enfermedad del oído interno
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10047393
    E.1.2Term Vestibular neuronitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of SENS-111 in Acute Unilateral Vestibulopathy (AUV)
    Para demostrar la eficacia de SENS-111 en la vestibulopatía unilateral aguda (AUV)
    E.2.2Secondary objectives of the trial
    -to explore the effect of SENS-111 on quality of life
    - to determine the optimal dose regimen for SENS-111
    - to evaluate safety and tolerability of SENS-111 in patients with AUV
    - to evaluate the effect of SENS-111 on long term recovery of vestibular function
    -to characterize the plasma exposure to SENS-111 in patients with AUV
    -to preliminary evaluate the health economics of SENS-111
    •Estudiar el efecto de SENS-111 sobre la calidad de vida
    •Determinar la pauta posológica óptima de SENS-111
    •Evaluar la seguridad y la tolerabilidad de SENS-111 en pacientes con VUA
    •Evaluar el efecto de SENS-111 sobre la recuperación a largo plazo de la función vestibular
    •Caracterizar la exposición en plasma a SENS-111 en pacientes con VUA
    •Evaluar de forma preliminar la farmacoeconomía de SENS-111
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients
    2. Aged ≥18 years and <75 years
    3. Suffering from an acute episode of vertigo of peripheral origin defined as:
    a.Severe (≥ 60mm on the standing vertigo intensity visual analog scale)
    b.Prolonged (more than 6 hours),
    c.Associated with imbalance (and/or postural imbalance) and nausea (and/or vomiting)
    d.Spontaneous nystagmus toward the unaffected ear (fast phase) which is suppressed or reduced by visual fixation confirmed by oculography
    e.Gain of the vestibulo ocular reflex (VOR) <0.7, measured by the video- head impulse test (HIT) and/or difference between the 2 labyrinths >25% according to the caloric test (de Jongkees’ formula).
    4. Affiliated or is a beneficiary to a health insurance system (if applicable in the national regulations)
    5. Signed and dated written informed consent.
    1.Ambos sexos
    2.≥18 años y <75 años de edad
    3.Sufrir un episodio agudo de vértigo de origen periférico definido como:
    a.Severo (≥60 mm en la escala visual analógica de intensidad del vértigo en posición erguida)
    b.Prolongado (más de 6 horas),
    c.Asociado con desequilibrio (y/o desequilibrio postural) y náuseas (y/o vómitos)
    d.Nistagmo espontáneo hacia el oído no afectado (fase rápida) que se suprime o reduce mediante fijación visual confirmada por oculografía
    e.Ganancia del reflejo vestíbulo ocular (RVO) <0,7, medido mediante la prueba de impulso cefálico (HIT) asistida por vídeo y/o diferencia entre los 2 laberintos >25 % según la prueba calórica (fórmula de Jongkee).
    4.Afiliado o beneficiario de un seguro sanitario (si procede según la normativa nacional)
    5.Consentimiento informado por escrito firmado y fechado
    E.4Principal exclusion criteria
    1. Vertigo duration of less than 6 hours before randomization
    2. Acute continuous vertigo lasting more than 72 hours prior to randomization
    3. Acute hearing loss during or after the onset of vertigo.
    4. Acute unilateral tinnitus during or after the onset of vertigo
    5. History of acute or chronic vestibular diseases (including Ménière’s disease, acute labyrinthitis, vestibular migraine...), vestibular dysfunction, previous episode of acute unilateral vestibulopathy or prolonged vertigo.
    6. Ongoing Benign paroxysmal positional vertigo (BPPV)
    7. History of prior acute central vestibular lesion.
    8. Acute or chronic disease of middle ear (infections, otitis)
    9. Concurrent Varicella Zoster Virus (VZV) ear infection (Herpes zoster oticus)
    10. History of cochlear implants
    11. Neurological disorders including stroke, brainstem or cerebellar dysfunction within the last 3 months (In case of possible stroke of the brainstem or cerebellum, the diagnosis should have been excluded by a MRI performed in the past 48 hours)
    12. Past or concomitant treatment with ototoxic chemotherapy
    13. Past history of seizures or convulsions
    14. Head trauma within the last 10 days prior to randomization
    15. Aminoglycosides in the past 6 months given via systemic or transtympanic administration
    16. Concomitant treatment with any of the followings within the last 24 hours prior to randomization if more than 2 doses have been taken:
    a. Antihistamines: diphenhydramine, cyclizine, dimenhydrinate, meclizine, hydroxyzine, promethazine,
    b. Cinnarizine, flunarizine
    c. Central anti-dopaminergics: neuroleptics, unless the dose is stable for at least 1 month prior to randomization and no changes are expected during the course of the study
    d. Benzodiazepines
    e. Histaminergics (e.g., betahistine)
    f. Scopolamine, homatropine
    g. Gabapentin, pregabalin
    h. Acetylleucine, 5HT3 antagonists (ondensetron, granisetron, palonosetron etc..)
    i. Piracetam, piribedil, trimetazidine,
    j. Corticosteroids (oral or injectable) unless the dose is stable for at least 1 month prior to randomization and no changes are expected during the course of the study
    17. Treatment with any investigational agent within 4 weeks prior to randomization or 5 half-lives of the investigational drug (whichever is longer)
    18. Prior participation in a clinical trial with SENS-111
    19. History of malignancy other than effectively treated carcinoma in-situ of the cervix, or adequately treated non-metastatic squamous or basal cell carcinoma of the skin, within 5 years
    20. Known history of, or concomitant severe hepatic, gastrointestinal, cardiovascular, respiratory, neurological, psychiatric, hematological, renal, or dermatological disease, or any condition, psychiatric, substance abuse, or otherwise, that, in the opinion of the Investigator might interfere with the evaluation of study treatment or warrant exclusion.
    21. Pregnancy (a negative pregnancy test is required for all women of childbearing potential (WOCBP) before initiation of treatment
    22. Male and female patients of child-bearing potential who are unwilling to use an
    highly effective contraception while enrolled on study and receiving the experimental drug, and for at least 1 month after the last intake of the investigational product. Highly effective therapy includes:
    a. combined (estrogen and progestogen containing) hormonal contraception
    associated with inhibition of ovulation: oral, intravaginal or transdermal
    b. progestogen-only hormonal contraception associated with inhibition of
    ovulation 1 : oral, injectable or implantable
    c. intrauterine device (IUD)
    d. intrauterine hormone-releasing system ( IUS)
    e. bilateral tubal occlusion
    f. vasectomised partner
    g. sexual abstinence
    (see appendix 11 for complete guidance)
    23. Nursing mothers
    24. Severe abnormal laboratory findings
    a. Creatininemia >1.5 upper limit of normal (ULN))
    b. INR >1.7 ULN, Total bilirubin >2 ULN
    c. ALAT and/or ASAT > 3 x ULN
    d. Hemoglobin <0.9 Giga/L and/or
    e. Neutrophils <1,5 Giga/L and/or
    f. Platelets <100 Giga/L
    25. Patients who, in the opinion of the Investigator, have significant medical or psychosocial findings that warrant exclusion. Examples of significant problems include, but are not limited to other serious non-malignancy-associated medical conditions that may be expected to limit life expectancy or significantly increase the risk of serious adverse event (SAEs) and any condition, psychiatric, substance abuse, or otherwise, that, in the opinion of the Investigator, would preclude informed consent, consistent follow-up, or compliance with any aspect of the study
    26. Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
    1.Duración del vértigo menor a 6 horas antes d aleatorización 2.Vértigo agudo continuo duración de mas d 72 hrs antes de aleatorización 3.Hipoacusia aguda durante o tras inicio del vértigo 4.Acúfenos unilaterales agudos durante o tras el inicio del vértigo
    5.Antecedentes de enfermedades vestibulares agudas o crónicas como enfermedad Ménière laberintitis aguda, migraña vestibular enfermedad vestibular episodio previo de vestibulopatía unilateral aguda o vértigo prolongado 6.Vértigo posicional paroxístico benigno (VPPB) en curso 7.Antecedentes de lesión vestibular central aguda previa 8.Enfermedad aguda o crónica del oído medio (infecciones otitis) 9.Infección de oído por el virus de la varicela zóster concurrente (herpes zóster ótico) 10.Antecedentes de implantes cocleares 11.Trastornos neurológicos como accidente cerebrovascular disfunción de tronco encefálico o cerebelar en últimos 3 meses (en caso de posible accidente cerebrovascular de tronco encefálico o de cerebelo deberá haberse excluido el diagnóstico mediante la realización de una RMN en las últimas 48 hrs 12.Tto pasado o concomitante con quimioterapia ototóxica 13.Antecedentes pasados de crisis epilépticas o convulsiones e.Traumatismo craneal durante los últimos 10 días previos a aleatorización
    15.Tto con aminoglucósidos en últimos 6 meses administrados vía sistémica o transtimpánica
    16.Tto concomitante con siguientes medicamentos en últimas 24 hrs previas aleatorización si se han tomado más de 2 dosis:a.Antihistamínicos: difenhidramina ciclizina dimenhidrinato meclizina hidroxizina prometazina b.Cinarizina flunarizina c.Antidopaminérgicos centrales: neurolépticos, excepto si la dosis es estable durante al menos 1 mes antes de la aleatorización y no se esperan cambios durante el transcurso del estudio d.Benzodiacepinas e.Histaminérgicos p. ej betahistina f.Escopolamina homatropina g.Gabapentina pregabalina h.Acetil leucina antagonistas de 5HT3 (ondensetrón, granisetrón, palonosentrón etc) i.Piracetam piribedilo trimetazidina j.Corticosteroides (orales o inyectables) excep si dosis es estable durante al menos 1 mes antes de aleatorización y no se esperan cambios durante el estudio 17.TTo con cualquier fármaco en investigación en las 4 semanas previas a aleatorización o 5 semividas del fármaco del estudio (lo más largo)
    18.Participación previa en un ensayo clínico con SENS-111. 19.Antecedentes en últimos 5 años d neoplasia maligna distinta al carcinoma de cuello uterino in situ tratado con eficacia o carcinoma espinocelular o basocelular no metastásico adecuadamente tratado
    20.Enfermedad concomitante o antecedentes conocidos de enfermedad hepática gastrointestinal cardiovascular respiratoria neurológica psiquiátrica hematológica renal o dermatológica grave o cualquier afección psiquiátrica toxicomanía o de otro tipo que en opinión del investigador pueda interferir con la evaluación del tratamiento del estudio o justifique la exclusión 21.Embarazo 22.Pacientes ambos sexos en edad fértil no dispuestos a utilizar un método anticonceptivo altamente eficaz durante su participación y que reciben el fármaco experimental, y durante al menos un mes después de la última ingesta del producto en investigación. Entre los tratamientos altamente eficaces se incluyen:
    a.anticonceptivos hormonales combinados (con estrógeno y progestágeno) asociados con la inhibición de la ovulación: orales intravaginales o transdérmicos
    b.anticonceptivos hormonales d progestágeno solamente asociados a la inhibición de la ovulación 1 [sic]: orales, inyectables o implantables
    c.dispositivo intrauterino (DIU)
    d.sistema intrauterino liberador de hormonas (SIU)
    e.ligadura bilateral de trompas
    f.pareja con vasectomía
    g.abstinencia sexual
    (para obtener una guía completa consulte el apéndice 11)
    23.Madres lactantes
    24.Hallazgos de laboratorio anómalos severos
    a.Creatininemia >1,5 veces el límite superior de la normalidad (LSN)
    b.INR >1,7 x LSN, bilirrubina total >2 x LSN
    c.ALAT y/o ASAT >3 x LSN
    d.Hemoglobina <0,9 Giga/l y/o
    e.Neutrófilos <1,5 Giga/l y/o
    f.plaquetas <100 Giga/l
    25.Pacientes que, en opinión del investigador, presentan hallazgos médicos o psicosociales significativos que justifican la exclusión. Entre los ejemplos de problemas significativos se incluyen, entre otros, otras enfermedades no asociadas con neoplasias malignas graves que pueden limitar la esperanza de vida o aumentar significativamente el riesgo de acontecimiento adverso grave (AAG), así como cualquier afección psiquiátrica, toxicomanía, o de otro tipo, que, en opinión del investigador, pudiera impedir la concesión del consentimiento informado, un seguimiento constante o el cumplimiento de cualquier aspecto del estudio
    26.paciente es el investigador o cualquier investigador colaborador, ayudante de investigación, farmacéutico, coordinador del estudio, otro miembro del personal o su familiar directamente implicado en la realización del protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the vertigo intensity measured by the AUC of the Vertigo Intensity Visual Analogue Scale (VI-VAS) in standing position over the 4 treatment days (8 post baseline assessments)
    El criterio de valoración principal es la intensidad del vértigo medida mediante el área bajo la curva (ABC) de la escala visual analógica de intensidad del vértigo (EVA-IV) en posición erguida durante los 4 días de tratamiento (8 evaluaciones postiniciales)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over the 4 treatment days
    Durante los 4 días de tratamiento
    E.5.2Secondary end point(s)
    - worst spontaneous vertigo intensity measured by the AUC of the worst vertigo visual analogue scale (VI-VAS) over the 4 treatment days (8 hours post baseline assessment)
    - Change from baseline of the total score of the Romberg tests at the end of the treatment (D5) and end of study (D28)
    - Peak slow phase velocity of the peripheral vestibular spontaneous nystagmus, measured by oculography in darkness at the end of treatment (D5) and the end of study (D28)
    -Nausea intensity measured by the AUC of the Nausea Intensity Visual Analogue Scale over the 4 treatment days (8post baseline assessments)
    - The functional disability at the end of study (D28) assessed by the Dizziness Handicap Inventory (DHI) functional subscale score and the Vestibular Disorder Activities of Daily Living Scale (VADL)
    •Peor intensidad del vértigo espontáneo medida mediante el ABC de la escala analógica del peor vértigo (EVA-IV) durante los 4 días de tratamiento (8 evaluaciones postiniciales)
    •Cambio con respecto al valor inicial de la puntuación total de las pruebas de Romberg al final del tratamiento (D5) y al final del estudio (D28).
    •Pico de velocidad de la fase lenta del nistagmo espontáneo vestibular periférico, medido mediante oculografía en oscuridad al final del tratamiento (D5) y al final del estudio (D28).
    •Intensidad de las náuseas medida mediante el ABC de la escala visual analógica de intensidad de las náuseas durante los 4 días de tratamiento (8 evaluaciones postiniciales)
    •La discapacidad funcional al final del estudio (D28) evaluada mediante la puntuación de la subescala funcional del inventario de discapacidad por mareo (Dizziness Handicap Inventory, DHI) y la escala de actividades cotidianas de enfermedades vestibulares (Vestibular Disorders Activities of Daily Living Scale, VADL)
    E.5.2.1Timepoint(s) of evaluation of this end point
    •- worst spontaneous vertigo intensity: over the 4 treatment days (8 hours post baseline assessment)
    - Change from baseline of the total score of the Romberg tests at the end of the treatment (D5) and end of study (D28)
    - Peak slow phase velocity of the peripheral vestibular spontaneous nystagmus: at the end of treatment (D5) and the end of study (D28)
    -Nausea intensity: over the 4 treatment days (8 post baseline assessments)
    - The functional disability at the end of study (D28) assessed by the Dizziness Handicap Inventory (DHI) functional subscale score and the Vestibular Disorder Activities of Daily Living Scale (VADL)
    •Peor intensidad d vértigo espontáneo medida con el ABC d escala analógica d peor vértigo durante los 4 días d tratamiento(8 eval postiniciales)
    •Cambio respecto a valor inicial d puntuación total d pruebas de Romberg al final del tto(D5)y al fin destudio(D28)
    •Pico de velocidad de la fase lenta del nistagmo espontáneo vestibular periférico medido mediante oculografía en oscuridad al final del tratamiento(D5) y al final del estudio(D28)
    •Intensidad de las náuseas medida mediante el ABC d escala visual analógica de intensidad de las náuseas durante los 4 días de tto (8 eval postiniciales)
    •Discapacidad funcional a fin d estudio (D28) evaluada mediante la puntuación de subescala funcional de inventario d discapacidad x mareo y escala de actividades cotidianas d enfermedades vestibulares
    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 Yes
    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 trial3
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Israel
    Korea, Democratic People's Republic of
    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
    Data Base Lock
    Cierre base de datos
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months20
    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: 104
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 103
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 133
    F.4.2.2In the whole clinical trial 207
    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)
    If the event would occur again, patients would be treated by the current Standard of Care
    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 Decision2018-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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