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    Summary
    EudraCT Number:2018-001958-10
    Sponsor's Protocol Code Number:MD2018
    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:2018-08-21
    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 number2018-001958-10
    A.3Full title of the trial
    Dexamethasone 21-dihydrogenphosphat and Triamcinolone acetonide in the treatment of Menière´s disease: a randomized, multicentric efficacy trial
    Dexamethasone 21-dihydrogenphosphat und Triamcinolone acetonide in der Behandlung von Morbus Menière: eine randomisierte, multizentrische Wirksamkeitsstudie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy trial of two therapies in Menière´s disease
    Wirksamkeitsstudie zweier Therapien bei Morbus Menière
    A.3.2Name or abbreviated title of the trial where available
    An efficacy trial of intratympanic steroid therapy in Menierè´s disease patients
    Wirksamkeitsstudie von intratympanalen Steroidtherapien bei Morbus Menière
    A.4.1Sponsor's protocol code numberMD2018
    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 SponsorAbteilung für Hals-, Nasen- und Ohrenkrankheiten MUW, AKH Wien
    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 supportUniversitätsklinik für Hals-Nasen-Ohrenkrankheiten MUW
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinik für Hals-, Nasen- und Ohrenkrankheiten MUW, AKH Wien
    B.5.2Functional name of contact pointHNO Ambulanz 8J
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtle 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.6E-mailchristoph.arnoldner@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 holderDermapharm 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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNTRIAMCINOLONE ACETONIDE
    D.3.9.3Other descriptive nameVolon A 40
    D.3.9.4EV Substance CodeSUB04936MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    D.2.1.1.1Trade name Fortecortin
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono GmbH
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNDexamethasone-21-dihydrogenphosphat
    D.3.9.3Other descriptive nameDEXAMETHASONE DIHYDROGEN PHOSPHATE DISODIUM PH. EUR.
    D.3.9.4EV Substance CodeSUB176825
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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
    In our study we try to evaluate the effect of intratympanic Triamcinolon acetonide and Dexamethason 21-dihydrohenphosphat on vertigo control calculation, Hydrops MRI, vHIT (video head impuls test), caloric testing, audiological examination including discrimination of speech test and on the basis of a quality of life questionnaire.
    Mit dieser Studie wird der Effekt von Triamcinolon acetonide und Dexamethason 21-dihydrohenphosphat anhand von Vertigo Control, Hydrops MRI , Video Kopf Impulstest, kalorischer Testung, Audiometrie und auf Basis von Lebensqualitätsfragebögen eruiert.
    E.1.1.1Medical condition in easily understood language
    We try to evaluate the effect of Triamcinolon acetonide and Dexamethason 21-dihydrohenphosphat applied through the middle ear, on specific vertigo tests, the reduced attack frequency and MRI
    Mit dieser Studie wird der Effekt von Triamcinolon acetonide und Dexamethason 21-dihydrohenphosphat anhand von speziellen Schwindeltestungen, MRT und der Reduktion der Schwindelattacken eruiert.
    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
    To assess the influence of intratympanic corticosteroid treatment (Dexamethasone 21-dihydrogenphosphat or Triamcinolone acetonide) on vertigo control in Menière’s disease patients after 24 months
    Um den Einfluss von intratympanale Kortikosteroid-Behandlung (Dexamethason 21-Dihydrogenphosphat oder Triamcinolon Acetonid) auf Schwindel Kontrolle bei Menière-Patienten nach 24 Monaten zu beurteilen
    E.2.2Secondary objectives of the trial
    •To assess the improvement in quality of life in each group and the difference between the Groups on quality of live questionnaires (follow-up 24 months)
    •To assess the difference in treatment efficacy between Dexamethasone and Triamcinolone in audiometry, Video Head impuls test and caloric test 6 and 24 months after therapy
    • To assess the improvement in audiometry in both groups 6 and 24 months after therapy
    • To assess the correlation between the outcomes of Video Head Impuls Test and caloric test in both groups and the difference between the groups
    • To assess the treatment efficacy of Dexamethasone and Triamcinolone and the difference between the groups as measured by hydrops MRI
    •To assess the correlation between vertigo control and Hydrops MRI results
    •To assess the influence on the course of disease by therapy.
    .)Evaluation der Verbesserung der Lebensqualität anhand von Lebensqualitätsfragebögen in beiden Gruppen und den Unterschied zwischen beiden Gruppen (follow-up 24 Monate)
    .)Evaluation des Unterschieds des Therapieeffekts zwischen Dexamethason und Triamcinolon in Audiometrie, Video Kopf Impulstest, kalorischer Testung 6 und 24 Monate nach Therapie
    .) Evaluation der Verbesserung der Hörleistung in beiden Gruppen 6 und 24 Monate nach Therapie
    .) Evaluation der Korrelation zwischen den Ergebnissen von Video Kopf Impuls Test und kalorischer Testund in beiden Gruppen und zwischen den Gruppen
    .) Evaluation des Therapieeffekts von Dexamethason und Triamcinolon und des Unterschieds zwischen den Gruppen.
    .) Evaluation der Korrelation zwischen der Vertigo Control und des Hydrops MRIs
    .) Evaluation des Einflusses der Therapie auf den Krankheitsverlauf.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients, who suffer from „definite Menière´s disease “, according to the AAO-HNS guidelines.
    • Patients with no retrocochlear or intracerebral pathology on cMRI
    • Patients between 18 and 90 years
    • Patienten, die an "definite Menière´s disease" leiden, gemäß den AAO-HNS-Richtlinien.
    • Patienten ohne retrocochleare oder intrazerebrale Pathologie im cMRI
    • Patienten zwischen 18 und 90 Jahren
    E.4Principal exclusion criteria
    •Patients with severe neurological disorders
    •Patients with chronic otitis media
    •Patients who were already treated with Gentamicin
    •Patients younger than 18 years
    •Pregnant and breastfeeding women
    •Patients with Contrast agent allergy
    •Patients with contraindications against the administration of Triamcinolone acetonide and Dexamethason 21-dihydrogenphosphat
    •Patients who take corticoteroids on a regular basis
    •Patients with non MRI-compatible implants

    • Patienten mit schweren neurologischen Störungen
    • Patienten mit chronischer Otitis media
    • Patienten, die bereits mit Gentamicin behandelt wurden
    • Patienten jünger als 18 Jahre
    • Schwangere und stillende Frauen
    • Kontrastmittelallergie
    • Patienten mit Kontraindikationen gegen die Anwendung von Triamcinolonacetonid und Dexamethason 21-Dihydrogenphosphat Patienten, die Kortikosteroide regelmäßig einnehmen
    • Patienten, die regelmäßig Corticosteroide einnehmen
    • Patienten mit nicht MRT-kompatiblen Implantaten
    E.5 End points
    E.5.1Primary end point(s)
    Vertigo control rate 24 months after treatment with Triamcinolone acetonide and Dexamethasone 21-dihydrogenphosphat.
    Schwindelkontrollrate 24 Monate nach Behandlung mit Triamcinolonacetonid und Dexamethason 21-Dihydrogenphosphat.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months nach Therapie
    24 Monate nach Therapie
    E.5.2Secondary end point(s)
    The hearing outcomes in audiometry (Hz/dB, Air conduction, bone conduction) 6 and 24 months after therapy
    The video Head impuls Test (diminished function in one of the semicircular canals; yes/no) 6 and 24 months after therapy
    The caloric testing (diminished function of the vestibular organ; yes/no) 6 and 24 months after therapy
    The quality of life based on the Questionnaires 6 months and 24 months after therapy
    Hydrops MRI outcomes 6 and 24 months after therapy
    Die Hörergebnisse in der Audiometrie (Hz / dB, Luftleitung, Knochenleitung) 6 und 24 Monate nach der Therapie
    Die Video Kopf Impuls Test (verminderte Funktion in einem der Bogengänge; ja / nein) 6 und 24 Monate nach der Therapie
    Die kalorische Untersuchung (verminderte Funktion des vestibulären Organs; ja / nein) 6 und 24 Monate nach der Therapie
    Die Lebensqualität basiert auf den Fragebögen 6 Monate und 24 Monate nach der Therapie
    Hydrops MRT Ergebnisse 6 und 24 Monate nach der Therapie
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 and 24 months after therapy
    6 und 24 Monate nach Therapie
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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 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 concerned4
    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
    Letzte Kontrolle des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 2018-08-21. 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 state20
    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)
    Depending on the individual needs or wishes of the patient, further therapy or care will take place.
    Je nach individuellem Bedürfnis oder Wunsch des Patienten wird eine weiterführende Therapie oder Betreuung stattfinden.
    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 Decision2018-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-25
    P. End of Trial
    P.End of Trial StatusOngoing
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