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    Summary
    EudraCT Number:2008-005178-10
    Sponsor's Protocol Code Number:AM-101-CL-08-01
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-12-11
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2008-005178-10
    A.3Full title of the trial
    Efficacy of AM 101 in Patients with Acute Inner Ear Tinnitus: A Multi-Centre, Double-Blind, randomised, Placebo-Controlled, Multiple Dose, Group Comparison Phase II Study
    A.4.1Sponsor's protocol code numberAM-101-CL-08-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00860808
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameAM-101
    D.3.4Pharmaceutical form Gel for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntratympanic use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEsketamine hydrochloride
    D.3.9.1CAS number 33643-47-9
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number270
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAM-101
    D.3.4Pharmaceutical form Gel for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntratympanic use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEsketamine hydrochloride
    D.3.9.1CAS number 33643-47-9
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number810
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Acute inner ear tinnitus following acute acoustic trauma, sudden deafness, or acute otitis media.
    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 13.1
    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
    The primary objective of the study is the evaluation of the therapeutic benefit of three repeated dose intratympanic AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus following acute acoustic trauma, sudden deafness or acute otitis media.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are (a) safety and local tolerance of intratympanically applied AM-101 injections and (b) identification of the optimal dose of AM-101 in the treatment of persistent acute inner ear tinnitus from acute acoustic trauma, sudden deafness or acute otitis media.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Persistent tinnitus following acute acoustic trauma, sudden deafness, or acute otitis media with onset less than three months ago (i.e. acute tinnitus)
    • Tinnitus provoking incident of acute acoustic trauma, sudden deafness, or acute otitis media is documented by medical report
    • Minimum Masking Level (MML) of at least 5 dB SL
    • Age ≥ 18 years and ≤ 65 years
    • Negative pregnancy test for women of childbearing potential
    • Willing and able to attend the on-study visits
    • Must be able to read and understand the relevant study documents
    • Written informed consent before participation in the study
    E.4Principal exclusion criteria
    • Tinnitus that is not completely maskable
    • Fluctuating tinnitus
    • Intermittent tinnitus
    • Meniere’s Disease
    • Acute or chronic otitis media or otitis externa
    • Any ongoing therapy known as potentially tinnitus-inducing (e.g. aminoglycosides, cisplatin, loop diuretics, high doses of aspirin, quinine etc.)
    • Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 2 weeks, e.g. prednisolone, dexamethasone, pentoxyfilline, betahistine, diazepam, carbamazepine, sodium valproate and antidepressants
    • Any drug-based therapy for otitis media that is ongoing or was performed in the past 2 weeks
    • Concomitant use of any other NMDA receptor antagonist (e.g. memantine, dextromethorphan, ifenprodil)
    • Any ongoing or planned concomitant medication for the treatment of tinnitus until 90 days after study drug application
    • History or presence of drug abuse or alcoholism
    • Any clinically relevant respiratory, cardiovascular, neurological (except vertigo), or psychiatric disorder
    • Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction
    • Women who are breast-feeding, pregnant or who plan a pregnancy during the trial
    • Women of childbearing potential who declare being unwilling or unable to practice contraception such as hormonal contraceptives, sexual abstinence or intercourse with a vasectomised partner
    • Concurrent participation in another clinical trial with an investigational drug or participation in another clinical trial with an investigational drug within 30 days prior to study entry
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is defined as follows:

    Y : delta MML(SL) = MML(SL) (Day0) - MML(SL) (Day90),
    i.e. the absolute improvement of the sensation level (dB SL) of the minimum masking level (MML) between D0 and D90.

    Co-primary endpoints are defined as follows:
    The therapeutic effect will be assessed by two questions to the patients concerning their tinnitus perception:

    W : delta TLQ = Score TLQ (Day0) - Score TLQ (Day90),
    i.e. the improvement of the score of the tinnitus loudness question (TLQ) given on a scale from 0 to 100 by the patients between Day 0 and D 90.
    Z : delta TLQ = Score TAQ (Day0) - Score TAQ (Day90),
    i.e. the improvement of the score of the tinnitus annoyance question (TAQ) given on a scale from 0 to 100 by the patients between Day 0 and Day 90.

    Primary safety endpoints:
    Change in hearing threshold ≥ 15 dB from baseline to Day7, Day30, and Day90 in any two contiguous test frequencies in the treated ear. Primary safety endpoint is the Day 30 visit.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0, Day 7, Day 30, and Day 90
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    The following secondary endpoints are defined that focus on other aspects of tinnitus impair-ment as well as on tinnitus disability and handicap:
    • V : delta LM(SL) = LM(SL) (Day0) - LM(SL) (Day90),
    i.e. the absolute improvement of the sensation level (dB SL) of the tinnitus loudness match (LM) between Day0 and Day90.
    • Complete recovery rate, i.e. the percentage of patients who recover on Day90 to a MML(SL) of 0 dB (no tinnitus anymore).
    • Partial recovery rate, i.e. the percentage of patients who show at least 50% improvement in the MML(SL) between Day0 and Day90:
    [MML(SL)(Day0) – MML(SL)(Day90)] / MML(SL)(Day0) x 100 ≥ 50%.
    • Global impression of change questionnaire for tinnitus severity at study completion (Day90).
    • The change in tinnitus handicap from baseline as measured by the TBF-12 questionnaire at Day90.
    • The change in sleep impact by magnitude estimation from baseline to Day90 as assessed by three questions concerning sleeping difficulties, each assessed on a scale from 0 to 100

    Secondary safety endpoint:
    Percent and distribution of severity of Adverse Events (AE) and Serious Adverse Events (SAE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day0, Day7, Day 30, and Day 90.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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.8.3 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 EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    Randomisation and patient enrolment will be stopped, if based on a review of safety and tolerability data by the Safety Officer and after joint consultation between the Safety Officer and the Co-ordinating Investigators, further treatments are deemed not acceptable.
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 250
    F.1.3Elderly (>=65 years) No
    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 state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 240
    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 Decision2009-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-10
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