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    Summary
    EudraCT Number:2018-002474-52
    Sponsor's Protocol Code Number:AM-125-CL-18-01
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-20
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2018-002474-52
    A.3Full title of the trial
    Multicenter randomized controlled phase 2 trial to evaluate AM-125 in the treatment of acute peripheral vertigo following neurosurgery (TRAVERS)
    Multicentrické, randomizované, kontrolované klinické skúšanie fázy 2 na posúdenie lieku AM-125 pri liečbe akútneho periférneho vertiga po neurochirurgickom zákroku (TRAVERS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study investigating the safety and effectiveness of intranasal betahistine in patients suffering from vertigo (giddiness) after the removal of a tumor of the balance and hearing nerve
    Klinické skúšanie, ktoré skúma bezpečnosť a účinnosť betahistínu podávaného intranazálne u pacientov s vertigom (závratom) po odstránení nádoru nervu rovnováhy a sluchu
    A.3.2Name or abbreviated title of the trial where available
    TRAVERS
    A.4.1Sponsor's protocol code numberAM-125-CL-18-01
    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 SponsorAuris Medical AG
    B.1.3.4CountrySwitzerland
    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 supportAuris Medical AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAuris Medical AG
    B.5.2Functional name of contact pointDirector Translational Research
    B.5.3 Address:
    B.5.3.1Street AddressDornacherstrasse 210
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4053
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number4161210 1354
    B.5.5Fax number4161201 1351
    B.5.6E-mailih@aurismedical.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 namebetahistine dihydrochloride
    D.3.2Product code AM-125
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBetahistine dihydrochloride
    D.3.9.1CAS number 5579-84-0
    D.3.9.2Current sponsor codeAM-125
    D.3.9.3Other descriptive nameBETAHISTINE DIHYDROCHLORIDE; 2-(2-(Methylamino)ethyl)pyridine dihydrochloride; N-methyl-N-(2-pyridin-2-ylethyl)amine dihydrochloride; Methyl(2-[2- pyridyl]ethyl)amine; N-methyl-2-(pyridin-2-yl)ethanamine dihydrochloride
    D.3.9.4EV Substance CodeSUB192701
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    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 Yes
    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 namebetaserc
    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 INNbetahistine dihydrochloride
    D.3.9.1CAS number 5579-84-0
    D.3.9.3Other descriptive nameBETAHISTINE DIHYDROCHLORIDE; 2-(2-(Methylamino)ethyl)pyridine dihydrochloride; N-methyl-N-(2-pyridin-2-ylethyl)amine dihydrochloride; Methyl(2-[2- pyridyl]ethyl)amine; N-methyl-2-(pyridin-2-yl)ethanamine dihydrochloride
    D.3.9.4EV Substance CodeSUB25919
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    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.IMP: 3
    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 namebetahistine dihydrochloride
    D.3.2Product code AM-125
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBetahistine dihydrochloride
    D.3.9.1CAS number 5579-84-0
    D.3.9.2Current sponsor codeAM-125
    D.3.9.3Other descriptive nameBETAHISTINE DIHYDROCHLORIDE; 2-(2-(Methylamino)ethyl)pyridine dihydrochloride; N-methyl-N-(2-pyridin-2-ylethyl)amine dihydrochloride; Methyl(2-[2- pyridyl]ethyl)amine; N-methyl-2-(pyridin-2-yl)ethanamine dihydrochloride
    D.3.9.4EV Substance CodeSUB192701
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 4
    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 namebetahistine dihydrochloride
    D.3.2Product code AM-125
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBetahistine dihydrochloride
    D.3.9.1CAS number 5579-84-0
    D.3.9.2Current sponsor codeAM-125
    D.3.9.3Other descriptive nameBETAHISTINE DIHYDROCHLORIDE; 2-(2-(Methylamino)ethyl)pyridine dihydrochloride; N-methyl-N-(2-pyridin-2-ylethyl)amine dihydrochloride; Methyl(2-[2- pyridyl]ethyl)amine; N-methyl-2-(pyridin-2-yl)ethanamine dihydrochloride
    D.3.9.4EV Substance CodeSUB192701
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 placeboNasal spray, solution
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of acute peripheral vertigo
    Liečba akútneho periférneho vertiga
    E.1.1.1Medical condition in easily understood language
    Treatment of vertigo (giddiness) after removal of a tumor of the balance and hearing nerve
    Liečba vertiga (závratu) po odstránení nádoru nervu rovnováhy a sluchu
    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 LLT
    E.1.2Classification code 10059614
    E.1.2Term Vestibular vertigo
    E.1.2System Organ Class 100000004854
    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 Part A is
    a. to explore and provide an estimate of the dose response curve for AM-125, and
    b. to evaluate the efficacy of AM-125 compared to placebo in reducing the symptoms of vestibular dysfunction and accelerating vestibular compensation following neurosurgery.

    The primary objective of Part B is to evaluate the efficacy of two selected doses of AM-125 versus placebo, as determined based on the results from Part A, in reducing the symptoms of vestibular dysfunction and accelerating vestibular compensation following neurosurgery compared to placebo.
    E.2.2Secondary objectives of the trial
    The secondary objective of Part A is to compare the treatment effect of oral betahistine (open label) versus AM-125 in reducing the symptoms of vestibular dysfunction and accelerating vestibular compensation following neurosurgery.
    The secondary objective of both Part A and Part B is to describe the safety and tolerability of AM-125 in the treatment of acute peripheral vertigo following neurosurgery.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects have to meet all of the following inclusion criteria to be eligible for enrolment into the study:
    1. Scheduled for neurosurgery (vestibular schwannoma resection, labyrinthectomy or vestibular neurectomy)
    2. Small to moderately large vestibular schwannoma (Koos grade I-III; Samii grade T1-T3b; ≤ 30 mm in diameter in cerebellopontine angle) that does not displace the brainstem, documented by magnetic resonance imaging not older than six months.
    or
    Indication for labyrinthectomy or vestibular neurectomy.
    3. Confirmed vestibular function on both sides (> 6 deg/sec sum of bithermal max. slow phase velocity on the affected side in caloric video/electronystagmography (VNG/ENG) and > 10 deg/sec sum of bithermal max. slow phase velocity on the contralateral side).
    4. Presence of symptoms of acute peripheral vertigo:
    • Subjective symptoms of vertigo (rating of at least “two” in EEV questionnaire question 1: illusion of movement)
    • Spontaneous nystagmus beating towards the contralateral side.
    SVV deviation > 2.5°from the true vertical.
    5. Age at SV (screening visit) ≥18 years and ≤70 years.
    6. Negative urine pregnancy test for women of childbearing potential.
    7. Willing and able to attend the study visits.
    8. Able to read and understand study documents, to complete the relevant questionnaires and rating scales and follow Investigator instructions.
    9. Signed informed consent.
    E.4Principal exclusion criteria
    1. Prior radiotherapy (gamma knife, intensity modulated radiation therapy) irradiating the brain-stem with more than 4 Gy.
    2. Any ongoing other peripheral vestibular disorder (e.g. Meniere’s disease, benign paroxysmal vertigo, vestibular neuritis) or central vestibular disorder (e.g. vestibular migraine, central vertigo).
    3. Vestibular rehabilitation therapy or presurgical gentamicin therapy (i.e. “pre-habilitation therapy”) within the past three months prior to neurosurgery.
    4. Any clinically relevant nasal obstruction or pathology precluding effective and/or safe intranasal delivery.
    5. Diagnosis of phaeochromocytoma.
    6. Ongoing upper respiratory tract infection or allergic rhinitis (symptomatic).
    7. Any treatment with antihistamines, anti-emetics or benzodiazepines that is ongoing or planned during the IMP treatment period.
    8. Any history of clinically relevant drug hypersensitivity, urticaria, or other severe allergic diathesis as well as current moderate or severe allergic disorders or hay fever.
    9. Subjects with diagnosed anxiety disorders, depression, schizophrenia or other significant psychiatric diseases requiring current drug treatment or subjects who required treatment in the previous three months prior to enrolment for any of these diseases.
    10. Any clinically relevant respiratory, cardiovascular, neurological disorder (e.g. neurofibromatosis type 2, except vertigo), relevant orthopaedic or visual limitation, relevant abnormality in laboratory test or physical examination or other abnormality that in the opinion of the Investigator or Sponsor may pose a safety risk to a subject in this study, which may confound efficacy or safety assessment, or may interfere with study participation.
    11. Any clinically relevant complication during or after neurosurgery that in the opinion of the Investigator or Sponsor may pose a safety risk to a subject in this study, which may confound efficacy or safety assessment, or may interfere with study participation.
    12. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe, abnormal drug reaction.
    13. History within the past two years or presence of drug abuse or alcoholism.
    14. Women who are breast-feeding, pregnant or who are planning to become pregnant during the study.
    15. Women of childbearing potential who are unwilling or unable to use an effective method of avoiding pregnancy from the SV until the end of the study. Effective methods of avoiding pregnancy are contraceptive methods with a Pearl index of less than 1 used consistently and correctly (including implantable, injectable, oral and transdermal contraceptives, intrauterine devices, or a sterile sexual partner, or being abstinent).
    16. Concurrent treatment with another investigational medicinal product or prior treatment with another investigational medicinal product within 30 days prior to randomization.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoints for Part A:
    • Improvement of time standing on foam (eyes closed) from TV
    (baseline) to FUV2;
    • Improvement in tandem Romberg test (eyes closed) from TV
    (baseline) to FUV2.
    Primary efficacy endpoint for Part B:
    • Improvement of time standing on foam (eyes closed) from TV
    (baseline) to FUV2.
    Primary safety endpoint for Part A and B:
    Frequency of occurrence of moderate-severe nasal symptoms at TV or
    any FUV and overall.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Part A for primary efficacy endpoints of Part A.
    End of Part B for primary efficacy endpoint of Part B.
    End of Part A and Part B for primary safety endpoint of Part A and B.
    E.5.2Secondary end point(s)
    Key secondary efficacy endpoint
    • Improvement in tandem Romberg test (eyes closed) from TV
    (baseline) to FUV4;
    Secondary efficacy endpoints:
    • Improvement of time standing on foam (eyes closed) from TV
    (baseline) to FUV1, FUV3 and FUV4;
    • Improvement in tandem Romberg test (eyes closed) from TV
    (baseline) to FUV1, FUV2 and FUV3;
    • Improvement in tandem gait from TV (baseline) to all FUVs;
    • Improvement of subjective visual vertical deviation from TV
    (baseline) to all FUVs
    • Change in the frequency of horizontal spontaneous nystagmus from
    TV (baseline) to all FUVs.
    Secondary safety endpoints:
    • Frequency of occurrence of any nasal symptoms at TV or any FUV and
    overall;
    • Occurrence of adverse events after intranasal administration;
    • Occurrence of adverse events after oral administration (part A only).
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Part A for secondary efficacy endpoints of Part A.
    End of Part B for secondary efficacy endpoints of Part B.
    End of Part A and/or Part B for secondary safety endpoints of Part A and
    B.
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Open-label arm for oral treatment in Part A (PR2)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 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
    Australia
    Belgium
    Canada
    Czechia
    France
    Germany
    Italy
    Poland
    Slovakia
    United Kingdom
    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
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 118
    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)
    Medical care after completion the study will be provided by either the study site or by the subject’s family practitioner or other as per the local standard.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-21
    P. End of Trial
    P.End of Trial StatusOngoing
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