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    Summary
    EudraCT Number:2020-005300-19
    Sponsor's Protocol Code Number:2020
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-23
    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 ConcernedAustria - BASG
    A.2EudraCT number2020-005300-19
    A.3Full title of the trial
    Intracochlear application versus round window instillation of Triamcinolone acetonide in patients with sudden sensorineural hearing loss-a comparative study
    Intracochleäre Applikation versus Rundfenster-Instillation von Triamcinolonacetonid bei Patienten mit plötzlichem Hörsturz- eine vergleichende Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Appilcation of a glucocorticoid into the inner ear of patients with sudden hearing loss
    Applikation eines Glucocorticoids ins Innerohr von Patienten mit plötzlichem Hörsturz- eine vergleichende Studie
    A.4.1Sponsor's protocol code number2020
    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 SponsorMedical University Vienna
    B.1.3.4CountryAustria
    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 supportMedical University Vienna
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportMed-El
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University Vienne
    B.5.2Functional name of contact pointDepartment of Otorhinolaryngology
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.6E-mailnavid.ahmadi@meduniwien.ac.at
    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 Yes
    D.2.1.1.1Trade name Volon A 40
    D.2.1.1.2Name of the Marketing Authorisation holderDermapharma AG
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameVolon A 40
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPLocal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIAMCINOLONE ACETONIDE
    D.3.9.1CAS number 76-25-5
    D.3.9.4EV Substance CodeSUB04936MIG
    D.3.10 Strength
    D.3.10.1Concentration unit 1X 100 milligrams/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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sudden sensorineural hearing loss (SSHL)
    Hörsturz
    E.1.1.1Medical condition in easily understood language
    Sudden hearing loss
    Hörsturz
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the effect of intracochlear application of triamcinolone acetonide in the treatment of patients with persistent SSHL undergoing a round membrane sealing after unsuccessful conservative therapy.
    Untersuchung des Effekts des intra-cochleär verabreichten Triamcinolonacetonid in der Behandlung von Hörsturz-Patienten, die von einem konservativen systemischen und lokalen Glukokortikoidtherapie nicht profitiert haben.
    E.2.2Secondary objectives of the trial
    Evaluation of the effect of triamcinolone acetonide on the speech intelligibility, intensity of tinnitus, quality of speech intelligibility and perception of the own health condition.
    Evaluation of the protein content of the perilymph.
    Untersuchung des Effekts von Triamcinolonacetonid auf die Sprachverständlichkeit, die Intensität des Tinnitus, die Qualität der Sprachverständlichkeit und die Wahrnehmung des eigenen Gesundheitszustandes.
    Untersuchung des Proteingehalts in der Perilymphe.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients between 18 and 80 years within 21 days beginning from the onset of SSHL
    Failed recovery after conservative treatment (systemic and intratympanic steroids) due to persisting SSHL
    Patients with SSHL with a mean hearing threshold shift of ≥30dB in three adjacent frequencies (0.125, 0.25, 0.5, 1, 2, 4, 8 kHz).
    Patients with an absolute mean hearing threshold of ≥70dB in the frequencies 0.5, 1, 2 and 4 kHz.
    Patients who signed the informed consent
    Alter zwichen 18 und 80 Jahre
    Akuter idiopathischer sensorineuraler Hörverlus (SSHL) mit einer mittleren Hörschwellenveränderung von ≥30dB in drei benachbachterten Frequenzen (0.125, 0.25, 0.5, 1, 2, 4, 8 kHz)
    Mittlere absolute Hörschwelle von ≥70dB in den Freuqnzen 0.5, 1, 2 and 4 kHz
    Zustand nach erfolgloser Therapie mit systemischer und/oder lokaler Glukokortikoidtherapie
    Auftritt von SSHL nicht länger als 21 Tagen zurückliegend
    Unterschriebene Teilnahmeerklörung
    E.4Principal exclusion criteria
    Missing informed consent

    Patients under permanent corticosteroid therapy

    Patients with hearing loss due to a (suspected) rupture of the round window membrane according to their history

    Patients with an intraoperatively detected leak of the round window membrane
    Repetitive SSHL within the last 12 months on the same side
    Other ear diseases systemic or otologic (e.g. middle ear diseases, vestibular schwannoma, fluctuating hearing loss, Menière´s Disease)
    Central nervous disorders
    Systemic diseases (treatment or chronic infections with HIV, hepatitis C or B, tuberculosis, insulin dependent diabetes mellitus, ongoing immune suppressive therapy of rheumatic or chronic-inflammatory illness, instable atherosclerotic diseases, heart diseases > NYHA II, severe psychiatric disorders, severe osteoporosis, ulcus gastric sive duodena, uncontrolled blood pressure (systolic >180 mmHg or diastolic >100 mmHg)
    Ongoing treatment with aminoglycosides (e.g. gentamicin), erythromycin, tetracycline, chemotherapeutic agents (e.g. cisplatin, 5-fluorouracil, bleomycin), high-dose aspirin (6 to 8 g/day), phosphodiesterase 5 inhibitors (e.g. sildenafil), antimalarial medications (e. g. quinine and chloroquine), loop diuretics (e.g. furosemide, torasemid, acetazolamide), immunosuppressive drugs
    Preexisting conductive hearing loss on the affected side (mean air-bone gap >10dB in the frequencies 0.5, 1, 2 and 4 kHz)
    Pregnancy or nursing
    Permanente Therapie mit Glukokortikoiden auf Grund einer anderen Krankheit dann SSHL
    Hörverlust, der auf Grund der Anamnese auf eine Ruptur der Rundfenstermembran zurückgeführt werden kann
    Intraoperativ festgestellte Ruptur der Rundfenstermembran
    Wiederholte SSHL auf der selben Seite innerhalb der letzten 12 Monaten
    Andere systemischen oder lokalen Ohrkrankheiten (z. B. Mittelohrkrankheiten, Akustikusneurinom, undulierendes Hörvermögen, Morbus Menière)
    Krankhiten des zentralen Nervensystems
    HIV
    Hetaptitis B
    Hepatitis C
    Tuberkolose
    Insulinabhängiger Diabetes
    Laufende immunsuppressive Therapie der rheumatischen oder chronisch-inflammatorischen Krankheiten
    Instabile Atherosklerose
    Herzinsuffizienz mit NYHA >2
    Schwere psychische Störungen
    Schwere Osteoporose
    Magenulkus oder Dünndarmulkus
    Therapieresistente arterielle Hypertonie (RR >180 mmHg systolisch oder >100 mmHg diastolisch)
    Laufende (systemische) Therapie mit folgenden Medikamenten:
    Aminogylkoside
    Erythromycin
    Tetracycline
    Chemotherapeutische Wirkstoffe (e.g. Cisplatin, 5-Fluoruracil, Bleomycin)
    Aspirin hochdosiert (6 - 8 g/Tag)
    Phosphodiesterase-5-Inhibitors (e.g. sildenafil)
    Antimalaria-Medikamente (e. g. quinine and chloroquine)
    Schleifendiuretika (e.g. Furosemide, Torasemid, Acetazolamide)
    Immunosuppressiva
    Vorbestehender Schalleitungsschwerhörigkeit der betroffen Seite (mittlere Schalleitungskluft >10dB in den Frequenzen 0.5, 1, 2 und 4 kHz)
    Schwangerschaft oder Stillen
    E.5 End points
    E.5.1Primary end point(s)
    Mean hearing threshold shift measured by the pure tone audiometry in three sequential frequencies most affected by SSHL.
    Mittlere Hörschwellenverschiebung gemessen mittels Reintonaudiometrie in drei aufeinanderfolgenden Frequenzen, die am stärksten vo Hörsturz betroffen sind.
    E.5.1.1Timepoint(s) of evaluation of this end point
    On day 30 after the treatment
    Am Tag 30 nach der Behandlung
    E.5.2Secondary end point(s)
    Freiburger monosyllable speech intelligibility test.
    Intensity of tinnitus (Mini Tinnitus Questionnaire)
    Quality of speech intelligibility (Speech, Spatial and Qualities of Hearing scale Questionnaire)
    Perception of the own health condition (AQOL and HUI-3-questionnaire)
    Proteomics of the perilymph
    Freiburgersprachverständlichkeitstest
    Intensität des Tinnitus (Mini-Tinnitus-Fragebogen)
    Qualität des Sprachverständlichkeits (SSQ-12-Fragebogen)
    Subjektive Wahrnehmung des eigenen Gesundheitszustands (AQOL- und HUI-3-Fragebogen)
    Proteingehalt in der Perilymphe
    E.5.2.1Timepoint(s) of evaluation of this end point
    On day 30 after the treatment
    Am Tag 30 nach der Behandlung
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Keine intracochleäre Applikation des untersuchten Prüfpräparats
    No intracochlear application of the IMP
    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
    Letzter Besuch des letzten Teilnehmers
    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 months0
    E.8.9.1In the Member State concerned 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-11-23. Yes
    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 state60
    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
    Keine
    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 Decision2021-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-01
    P. End of Trial
    P.End of Trial StatusOngoing
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