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    Summary
    EudraCT Number:2013-002077-21
    Sponsor's Protocol Code Number:AM-111-CL-13-01
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-14
    Trial results View 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 ConcernedCzechia - SUKL
    A.2EudraCT number2013-002077-21
    A.3Full title of the trial
    Efficacy and Safety of AM-111 in the Treatment of Acute Inner
    Ear Hearing Loss
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of AM-111 in the Treatment of Acute Inner
    Ear Hearing Loss
    A.3.2Name or abbreviated title of the trial where available
    HEALOS
    A.4.1Sponsor's protocol code numberAM-111-CL-13-01
    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 Ltd.
    B.5.2Functional name of contact pointTomas Meyer
    B.5.3 Address:
    B.5.3.1Street AddressThe Black Church, St. Mary’s Place
    B.5.3.2Town/ cityDublin 7
    B.5.3.3Post codeN/A
    B.5.3.4CountryIreland
    B.5.6E-mailear@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 Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/013/05
    D.3 Description of the IMP
    D.3.1Product nameAM-111
    D.3.2Product code AM-111
    D.3.4Pharmaceutical form Gel for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPAuricular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAM-111
    D.3.9.1CAS number 1624290-55-6
    D.3.9.2Current sponsor codeD-JNKI-1
    D.3.9.3Other descriptive nameXG-102
    D.3.9.4EV Substance CodeSUB114549
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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 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 Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/013/05
    D.3 Description of the IMP
    D.3.1Product nameAM-111
    D.3.2Product code AM-111
    D.3.4Pharmaceutical form Gel for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPAuricular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAM-111
    D.3.9.2Current sponsor codeD-JNKI-1
    D.3.9.3Other descriptive nameXG-102
    D.3.9.4EV Substance CodeSUB114549
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.8
    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 placeboGel for injection
    D.8.4Route of administration of the placeboIntratympanic use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic sudden sensorineural hearing loss
    E.1.1.1Medical condition in easily understood language
    Tinnitus
    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 19.1
    E.1.2Level PT
    E.1.2Classification code 10043882
    E.1.2Term Tinnitus
    E.1.2System Organ Class 10013993 - Ear and labyrinth disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).
    E.2.2Secondary objectives of the trial
    • Further evaluation of the dose response relationship for AM-111 in the recovery of ISSNHL;
    • Assessment of the efficacy of AM-111 in achieving complete remission of ISSNHL-related tinnitus;
    • Assessment of safety and local tolerance of AM-111.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Unilateral ISSNHL with onset within 72 hours prior to study treatment;
    2. Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across the 3 most affected contiguous air conduction audiometric pure tone frequencies (“pure tone average”, PTA);*
    3. Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air conducted PTA frequencies compared with the unaffected contralateral ear or reference values from a pre-existing audiogram or ISO 7029;2000 norm values in case of asymmetric hearing prior to the ISSNHL incident;*
    4. Age ≥ 18 and ≤ 65 years on the day of screening;
    5. Negative urine pregnancy test for women of childbearing potential. Women are not considered to be of childbearing potential if they meet one of the following criteria:
    - They have had a hysterectomy or tubal ligation at least one cycle prior to signing the Informed Consent Form (ICF) or
    - They are post-menopausal, with at least one year since their last menstrual period;
    6. Willing and able to attend the trial visits;
    7. Able to read and understand trial documents and follow Investigator instructions;
    8. Able to understand and follow trial personnel instructions during audiologic measurements;
    9. Willing and able to use adequate hearing protection and to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured;
    10. Willing and able to protect the ear canal and middle ear from water exposure for as long as the tympanic membrane is not fully closed;
    11. Signed Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved ICF.
    E.4Principal exclusion criteria
    1. Bilateral ISSNHL;
    2. Acute hearing loss from noise trauma, barotrauma or head trauma;
    3. History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière’s disease in the affected ear;
    4. History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
    5. History of acoustic neuroma or other retrocochlear damage in the affected ear;
    6. History of otosclerosis in the affected ear;
    7. Suspected perilymph fistula or membrane rupture in the affected ear;
    8. Congenital hearing loss;
    9. History of ISSNHL in the past 2 years;
    10. Otitis media or otitis externa that is ongoing or ended within 7 days prior to study treatment;
    11. Radiation therapy in the head and neck area within the past 5 years;
    12. Abnormality of the tympanic membrane in the affected ear that would preclude i.t. administration;
    13. Any pre-treatment within two weeks prior to enrolment, ongoing treatment or planned treatment of ISSNHL-related hearing loss or tinnitus including pharmacological medication or non-pharmacological treatment (other than prednisolone or prednisone reserve therapy following FUV2);
    14. Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics, quinine etc.) in the 3 months prior to trial inclusion;
    15. History within the past 2 years or presence of drug abuse or alcoholism;
    16. Subjects with diagnosed anxiety disorders, depression, schizophrenia or other significant psychiatric diseases requiring current drug treatment or subjects who required treatment in the previous 3 months prior to enrolment for any of these diseases;
    17. Any clinically relevant respiratory, cardiovascular, neurological disorder (except vertigo or tinnitus) 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;
    18. Known or suspected ongoing active infection of HIV, hepatitis C or B, or herpes zoster;
    19. Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
    20. Women of childbearing potential who are unwilling or unable to use an effective method of avoiding pregnancy from the screening visit until the end of the study (FUV4). 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, diaphragm with spermicide, male or female condoms with spermicide, or cervical cap, or a sterile sexual partner, or being abstinent);
    21. Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to randomisation (TV).
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    Absolute improvement in PTA from baseline to FUV3.

    Primary safety endpoint:
    Occurrence of clinically relevant hearing deterioration (defined as increase in air conduction hearing threshold ≥ 10 dB at the average of any two contiguous test frequencies) from baseline to FUV3 in the treated ear. The analysis will be conducted also with bone conduction hearing threshold values.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    • Absolute improvement in PTA from baseline to FUV1, FUV2 and FUV4 ;
    • Proportion of subjects receiving corticosteroid reserve therapy;
    • Frequency of complete hearing recovery at FUV3 and FUV4;
    • Frequency of complete tinnitus remission at FUV4 in subjects with ISSNHL-related tinnitus at baseline.

    Secondary safety endpoints
    • Occurrence of clinically relevant hearing deterioration from baseline to all FUVs (other than FUV3) (air conduction) in the treated ear;
    • Difference in occurrence of clinically relevant hearing deterioration from baseline to all FUVs between treated and untreated contralateral ear;
    • Occurrence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs), differentiated by causal relationship to:
    - The IMP;
    - The intratympanic IMP administration;
    - Other trial procedures; or
    - Other reasons not related to the trial.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 14, Day 28, Day 91
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Bulgaria
    Czech Republic
    Germany
    Hungary
    Poland
    Russian Federation
    Serbia
    Spain
    Taiwan
    Thailand
    Turkey
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 245
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 255
    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 needed, treatment or care after the subject has ended his/her participation in the trial will be the expected standard treatment of that condition.
    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 Decision2015-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-29
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