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    Summary
    EudraCT Number:2019-001540-22
    Sponsor's Protocol Code Number:MD2019
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-06-27
    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 ConcernedAustria - BASG
    A.2EudraCT number2019-001540-22
    A.3Full title of the trial
    Assessment of vertigo control rate following common treatments in
    Menière´s disease
    Schwindelkontrolle bei Morbus Menière
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vertigo control rate in Menière´s disease patients
    Schwindelkontrolle bei Morbus Menière
    A.4.1Sponsor's protocol code numberMD2019
    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- 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 Hals- Nasen- Ohrenkrankheiten MUW, AKH Wien
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinik Hals- Nasen- Ohrenkrankheiten MUW, AKH Wien
    B.5.2Functional name of contact pointHNO Ambulanz 8J
    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-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 Refobacin 80mg intratympanic injection (2ml)
    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 INNGENTAMICIN SULFATE
    D.3.9.1CAS number 1405-41-0
    D.3.9.3Other descriptive nameGentamicin Sulfate
    D.3.9.4EV Substance CodeSUB02327MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number66,65
    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 Xylocain 2% Ampullen
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading Limited
    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 nameLidocain HCL 2%-Hyaluronidase 75IE/ml
    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 INNLIDOCAINE HYDROCHLORIDE
    D.3.9.1CAS number 6108-05-0
    D.3.9.2Current sponsor codeLIDOCAINE HYDROCHLORIDE 1mg
    D.3.9.4EV Substance CodeSUB88133
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 the effect of common therapies in Menière´s disease patients on vertigo control calculation, Hydrops MRI, vHIT (video head impuls test) , caloric testing, audiological examination, and on the basis of quality of life questionnaires.
    In unserer Studie versuchen wir, die Auswirkungen gängiger Therapien bei Menière-Patienten anhand der Berechnung der Schwindelkontrolle, Hydrops-MRT, den vHIT-Test (Video Head Impuls Test), kalorische Testung, Audiogrammen und die Fragebogen zur Lebensqualität zu untersuchen
    E.1.1.1Medical condition in easily understood language
    we try to evaluate the effect of common treatments in Meniere´s disease patients on specific vertigo tests, the reduced attack frequency and MRI
    Wir versuchen, die Auswirkung üblicher Behandlungen bei Menière-Patienten auf bestimmte Schwindeluntersuchungen, die verringerte Anfallshäufigkeit und die MRT zu untersuchen
    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 efficacy of the treatment in Menière’s disease patients after 24 months quantified by the vertigo control rate
    Um die Wirksamkeit der Behandlung bei Patienten mit Menière-Krankheit nach 24 Monaten zu beurteilen.
    E.2.2Secondary objectives of the trial
    • To assess the correlation between hydrops MRI outcomes and the vertigo control in all groups 6 and 24 months after treatment
    • To assess the correlation between hydrops MRI outcomes and vHIT (video head impuls test) outcomes in all groups 6 and 24 months after treatment
    • To assess the correlation between hydrops MRI outcomes and caloric testing outcomes in all groups 6 and 24 months after treatment (except patients with LE and ventilation tubes
    • Zur Beurteilung der Korrelation zwischen den Hydrops-MRT-Ergebnissen und der Schwindelkontrolle in allen Gruppen 6 und 24 Monate nach der Behandlung
    • Beurteilung der Korrelation zwischen den MRT-Ergebnissen der Hydrops und den vHIT-Ergebnissen (Videokopfimpulstest) in allen Gruppen 6 und 24 Monate nach der Behandlung
    • Beurteilung der Korrelation zwischen den MRT-Ergebnissen der Hydrops und den Ergebnissen der kalorischen Tests in allen Gruppen 6 und 24 Monate nach der Behandlung (außer Patienten mit LE und Paukendrainage)
    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 between 18 and 90 years will be included.
    • Patients who underwent intratympanic steroid therapy within the last six months before therapy
    • Patients who underwent any conservative therapy within the last six months before therapy
    • Patients who had a ventilation tube until six months ago
    Patienten, die nach den AAO-HNS-Richtlinien an einer „bestimmten Menière-Krankheit“ leiden.
    • Patienten zwischen 18 und 90 Jahren werden eingeschlossen.
    • Patienten, die sich innerhalb der letzten sechs Monate vor der Therapie einer intratympanischen Steroidtherapie unterzogen haben
    • Patienten, die innerhalb der letzten sechs Monate vor der Therapie konservativ behandelt wurden
    • Patienten, die bis vor einem halben Jahr eine Paukendrainage hatten
    E.4Principal exclusion criteria
    • Patients with severe neurological disorders
    o Severe neurological disorders, which are relevant for our study are tumor diseases, neurodegenerative diseases, more than one epileptic seizure in patient´s history.
    • Patients younger than 18 years
    • Pregnant and breastfeeding women
    • Patients with retrocochlear or intracerebral pathology on cMRI
    • Patienten mit schweren neurologischen Störungen
    o Schwere neurologische Störungen, die für unsere Studie relevant sind, sind Tumorerkrankungen, neurodegenerative Erkrankungen und mehr als ein epileptischer Anfall in der Krankengeschichte des Patienten.
    • Patienten unter 18 Jahren
    • Schwangere und stillende Frauen
    • Patienten mit retrocochlearer oder intrazerebraler Pathologie bei cMRI
    E.5 End points
    E.5.1Primary end point(s)
    Vertigo control rate 24 months after treatment
    Schwindelkontrollrate 24 Monate nach der Behandlung
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 Months after therapy
    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 vHIT (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
    Das vHIT (verminderte Funktion der canales semicirculars; ja / nein) 6 und 24 Monate nach der Therapie
    Der kalorische Test (verminderte Funktion des Vestibularorgans; 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 No
    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) No
    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 2019-06-27. 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 Befürfnis 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 Decision2019-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-01-01
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