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    Summary
    EudraCT Number:2012-005002-22
    Sponsor's Protocol Code Number:PROHEARING
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-07-10
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-005002-22
    A.3Full title of the trial
    ACEMg mediated hearing preservation
    in cochlear implant patients receiving different electrode lengths
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vitamin mediated hearing preservation in cochelar implant patients receiving different electrode lengths
    A.4.1Sponsor's protocol code numberPROHEARING
    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 SponsorHannover Medical School
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEU under the FP7 program
    B.4.2CountryEuropean Union
    B.4.1Name of organisation providing supportMED-EL Medical Electronics
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation Hannover Medical School
    B.5.2Functional name of contact point Department of Otorhinolaryngology
    B.5.3 Address:
    B.5.3.1Street AddressCarl-Neuberg-Str. 1
    B.5.3.2Town/ cityHannover
    B.5.3.3Post code30625
    B.5.3.4CountryGermany
    B.5.4Telephone number49511 532 6565
    B.5.6E-maillenarz.thomas@mh-hannover.de
    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 nameSoundbites®
    D.3.4Pharmaceutical form Chewable 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 INNVitamin E
    D.3.9.1CAS number 7695-91-2
    D.3.9.3Other descriptive nameVITAMIN E ACETATE
    D.3.9.4EV Substance CodeSUB35355
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number44.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBETA-CAROTENE
    D.3.9.1CAS number 7235-40-7
    D.3.9.3Other descriptive nameBETA-CAROTENE 20%
    D.3.9.4EV Substance CodeSUB22485
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN ASCORBATE
    D.3.9.1CAS number 15431-40-0
    D.3.9.3Other descriptive nameascorbic acid
    D.3.9.4EV Substance CodeSUB03009MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number83.33
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMAGNESIUM
    D.3.9.1CAS number 7439-95-4
    D.3.9.4EV Substance CodeSUB14407MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number52.5
    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 Yes
    D.3.11.13.1Other medicinal product typeCombination of Vitamins A, E, C and Magnesium
    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 placeboChewable 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
    Cochlear implant patients in whom a cochlear implant preserving residual hearing is medically indicated
    E.1.1.1Medical condition in easily understood language
    Cochlear implant patients in whom a cochlear implant preserving residual hearing is medically indicated
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10019245
    E.1.2Term Hearing impaired
    E.1.2System Organ Class 10013993 - Ear and labyrinth disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective:
    The primary objective is to demonstrate that ACEMg is more efficacious than placebo in preserving residual hearing during cochlear implantation by comparing the hearing loss after 3 month at 500Hz in air conducted pure tone audiometry.
    E.2.2Secondary objectives of the trial
    Key secondary Objectives:
    • to investigate the drug effect over time (hearing loss in ACEMg compared to Placebo at 500Hz 6, 9 and 12 month post-operatively)
    • to compare ACEMg and Placebo at different frequencies of pure tone audiometry (125, 250 and 750 Hz, 1, 1,5, 2, 3, 4, 6 and 8 kHz) over time (month 3, 6, 9 and 12 post-operatively)
    • to compare efficacy by means of speech perception, functional hearing and impedances
    • to evaluate the effect of electrode length on hearing loss
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 years of age or older
    2. No or little benefit of conventional hearing aid, defined as preoperative auditory speech understanding of less or equal 60% in Freiburger monosyllables at 65 dB SPL, best aided in the ear to be implanted
    3. Residual hearing better or equal than 80 dB HL at 125 and 250 Hz and better or equal than 90 dB HL at 500 Hz in the ear to be implanted
    4. Ability to understand the study procedures, possible risks and benefits, and to give informed consent
    5. Informed Consent is signed
    6. Patients must agree not to use daily multi-vitamins or other supplements during the course of the study, and beginning at least 48 hours prior to first intake of the study medication
    7. Female patients ≥50 years of age at the day of inclusion who have been postmenopausal since at least 1 year
    OR
    female patients who have a negative hCG serum pregnancy test and meet one or more of the following criteria:
    - 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral ovariectomy with or without hysterectomy
    - Using proven oral, injected or implanted hormonal contraceptive methods
    - Intrauterine Device (IUD) or intrauterine system (IUS)
    - Barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide (foam / gel / film / cream / suppository)
    - Male sterilisation (if the absence of sperm in the ejaculate is documented. For female participants the vasectomized male partner should be the sole sexual partner for that subject)
    - True abstinence (Periodic abstinence and interruptus are not acceptable methods of contraception)
    - Only female sexual partners
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    1. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array, as confirmed by medical examination and imaging (e.g. DVT)
    2. Signs of retrocochlear or central origin to hearing impairment as confirmed by medical examination and imaging (e.g. DVT)
    3. Medical or psychological conditions which contraindicate surgery (e.g. active middle ear infections, tympanic membrane perforation)
    4. Pregnancy or lactation
    5. Additional handicaps that would prevent participation in evaluations
    6. Contraindications for ACEMg:
    6.1 hepatopathy (transaminases or γ-GT >= 2 x ULN (Upper Limit of Normal))
    6.2 severe renal insufficiency (Serum creatinine > 2 x
    ULN)
    6.3 disposition to kidney stones
    6.4 iron-storage disease (thalassemia, hemochromatosis, sideroblastic anaemia)
    6.5 co-medication with vitamin K-antagonists
    6.6 heavy smoking (≥ 20 cigarettes per day)
    7. Current participation in any other clinical trial and/or participation in another clinical trial within 30 days before the study begins
    E.5 End points
    E.5.1Primary end point(s)
    Hearing loss at the implanted ear at 500 Hz 3 months post-operatively (hearing loss = 3 months post-operatively threshold minus 1-2 days pre-operatively threshold) measured by air conducted pure tone audiometry
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months post-operatively
    E.5.2Secondary end point(s)
    1) Hearing loss at the implanted ear measured by pure tone audiometry at 500 Hz 6, 9 and 12 months post-operatively
    2) Hearing loss measured by pure tone audiometry for other frequencies (125 and 250 Hz, 1, 2, 8 kHz) over time (month 3, 6, 9 and 12 post-operatively)
    3) Speech perception by OLSA, month 12
    4) Functional Hearing questionnaire NCIQ, month 3 and 12
    5) Impedances [Ω] at all time points
    6) Occurrence of Tinnitus: questionnaire at all time points

    Safety Endpoints:
    1) All SAEs
    2) All AEs leading to discontinuation of IMP intake
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 6, 9 and 12 months post-operatively
    2) 3, 6, 9 and 12 months post-operatively
    3) 12 month
    4) 3 and 12 month
    5) all time points
    6) all time points

    Safety Endpoints:
    upon first administration of the IMP(s) and ends 30 days after the last application
    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 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) 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 trial2
    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 No
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 177
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 123
    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 state300
    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)
    none
    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 Decision2013-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-06-15
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