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    The EU Clinical Trials Register currently displays   43973   clinical trials with a EudraCT protocol, of which   7311   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-004496-71
    Sponsor's Protocol Code Number:104-201508
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-01-19
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-004496-71
    A.3Full title of the trial
    A prospective, randomized, double blind, placebo-controlled, multicenter, phase 3 efficacy and safety study of OTO-104 given as a single intratympanic injection in subjects with unilateral Meniere's disease.
    STUDIO DI FASE 3 PROSPETTICO, RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO VERSO PLACEBO, MULTICENTRICO VOLTO A VALUTARE L'EFFICACIA E LA SICUREZZA DI OTO-104 SOMMINISTRATO IN UNA SINGOLA INIEZIONE INTRATIMPANICA IN SOGGETTI CON SINDROME DI MENIERE UNILATERALE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to see of local application (in the ear) of dexamethasone (a corticosteroid) to people with Meniere's disease could help with their symptoms and if it is safe to use.
    Uno studio per vedere l'applicazione a livello locale (nell'orecchio) di desametasone (un corticosteroide) in persone con sindrome di Meniere che se sicuro da usare potrebbe aiutare a curarne i sintomi
    A.3.2Name or abbreviated title of the trial where available
    Not available
    Non disponibile
    A.4.1Sponsor's protocol code number104-201508
    A.5.4Other Identifiers
    Name:EudraCTNumber:2015-004496-71
    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 SponsorOTONOMY, INC.
    B.1.3.4CountryUnited States
    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 supportOtonomy Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOtonomy Inc.
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street Address4796 Executive Drive
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 619 323 2208
    B.5.5Fax number001 858 200 0933
    B.5.6E-mailbfinn@otonomy.com
    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 nameOTO-104
    D.3.2Product code OTO-104
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXAMETHASONE
    D.3.9.1CAS number 50-02-2
    D.3.9.2Current sponsor codeNon disponibile
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number36
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution 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
    Meniere's disease
    Sindrome di Meniere
    E.1.1.1Medical condition in easily understood language
    Meniere's disease is an inner ear disease. The symptoms are vertigo (room spinning), tinnitus (ringing in the ears or a feeling of fullness in the ears), and hearing loss.
    La sindrome di Meniere ¿ una malattia dell'orecchio interno. I sintomi sono: vertigini (giramenti di testa) tinnito (ronzio nelle orecchie o sensazione di pienezza nelle orecchie) e perdita dell'udito
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027183
    E.1.2Term Meniere's disease
    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
    To confirm the efficacy of OTO-104 in subjects with Meniere's disease, as measured by the number of definitive vertigo days (DVD) at Week 12 (the 4-week interval from Week 9 through Week 12).
    Confermare l'efficacia di OTO-104 in soggetti con sindrome di Meniere, misurata dal numero di giorni con vertigini oggettive alla settimana 12 (l'intervallo di 4 settimane dalla settimana 9 alla settimana 12).
    E.2.2Secondary objectives of the trial
    To describe the safety profile of OTO-104 in subjects with Meniere's disease.
    Descrivere il profilo di sicurezza di OTO-104 in soggetti con sindrome di Meniere.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject is a male or female aged 18 to 85 years, inclusive.
    - Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria.
    - Subject self-reports active, definitive vertigo episodes for the 2 months prior to the study lead-in period.
    - Subject has documented asymmetric sensorineural hearing loss at screening or within the past 12 months according to AAO-HNS 1995
    criteria defined as one of the following:
    a. The arithmetic mean of hearing thresholds (pure tone average, PTA) at 250, 500 and 1000 Hz of 15 dB or more higher than the PTA of 1000, 2000, and 3000 Hz,
    b. The arithmetic mean of PTA at 500, 1000, 2000 and 3000 Hz is 20 dB or more poorer in the ear in question than on the opposite side,
    c. It is the judgment of the investigator that the subject's hearing loss meets reasonable audiometric criteria for hearing loss characteristic of
    Meniere's disease, and if so, it should be justified and documented.
    - Subject is able to use the telephone to complete their daily diary. At the completion of the first 28 days of the lead-in period:
    - Subject completed at least 22 of 28 diary entries during the 4-week lead-in period.
    - Uomo o donna di età compresa tra 18 e 85 anni (compresi).
    - Diagnosi di sindrome di Meniere unilaterale secondo i criteri AAO-HNS 1995.
    - Episodi di vertigini oggettive attive, riportate dal soggetto, per 2 mesi prima del periodo iniziale dello studio.
    - Ipoacusia neurosensoriale asimmetrica documentata allo screening o negli ultimi 12 mesi secondo i criteri AAO-HNS 1995, definita in uno dei modi seguenti:
    a. la media aritmetica della soglia uditiva (media della soglia dei toni puri, PTA) a 250, 500 e 1000 Hz è superiore al PTA di 1000, 2000 e 3000 Hz per un valore di 15 dB o maggiore;
    b. la media aritmetica del PTA a 500, 1000, 2000 e 3000 Hz è inferiore nell'orecchio in questione rispetto al lato opposto per un valore di 20 dB o maggiore;
    c. secondo il giudizio dello sperimentatore l'ipoacusia del soggetto soddisfa criteri audiometrici ragionevoli per l'ipoacusia caratteristica della sindrome di Meniere e, in tal caso, deve essere giustificata e documentata.
    - I soggetti sono in grado di usare il telefono per completare il diario giornaliero. Al terminedei primi 28 giorni del periodo inziale:
    - Completamento di almeno 22 su 28 voci del diario durante il periodo iniziale di 4 settimane.
    E.4Principal exclusion criteria
    - Subject has an infection in the ear, sinuses, or upper respiratory system at the time of randomization.
    - Subject is pregnant or lactating.
    - Subject has a history of immunodeficiency disease.
    - Subject has an abnormality of the tympanic membrane in the affected
    ear that would increase the risk associated with intratympanic injection including but not limited to monomeric tympanic membrane.
    - Subject has used systemic steroids within 1 month prior to entering the lead-in period.
    - Subject has a hypersensitivity to dexamethasone or any of the excipients in OTO-104
    - Subject has previously been randomized to a trial of OTO-104.
    - Infezione in atto a carico dell'orecchio, dei seni o dell'apparato respiratorio superiore al momento della randomizzazione.
    - Gravidanza o allattamento.
    - Anamnesi di malattia da immunodeficienza.
    - Anomalia della membrana timpanica dell'orecchio interessato in grado di aumentare il rischio associato all'iniezione intratimpanica, compresa a titolo esemplificativo e non esaustivo membrana timpanica monomerica.
    - Utilizzo di steroidi sistemici nel mese precedente all'inizio del periodo iniziale.
    - Reazione da ipersensibilità al desametasone o ad uno qualsiasi degli eccipienti di OTO-104.
    - Precedente randomizzazione a una sperimentazione su OTO-104.
    E.5 End points
    E.5.1Primary end point(s)
    The number of definitive vertigo days (DVD) at Week 12 [the 4-week (28-day) interval from Week 9 through Week 12]
    L'endpoint primario di efficacia è il numero di giorni con vertigini oggettive alla settimana 12 [l'intervallo di 4 settimane (28 giorni) dalla settimana 9 alla settimana 12].
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    12 settimane
    E.5.2Secondary end point(s)
    - The number of definitive vertigo days (DVD) at Week 8 [the 4-week (28-day) interval from Week 5 through Week 8]
    - The number of definitive vertigo days (DVD) at Week 4 [the 4-week (28-day) interval from Week 1 through Week 4]
    - The change from baseline in vertigo frequency (VF) during the 4-week study interval (Week 9 through Week 12), where vertigo frequency is
    defined as the proportion of days during the 4-week interval where a definitive vertigo episode was recorded divided by the number of nonmissing
    diary entries for the relevant interval.
    The change from baseline with respect to severity of vertigo episodes as measured by the mean Vertigo Score during the 4-week study interval
    (Week 9 through Week 12)
    - The change from baseline in average daily count of vertigo episodes, during the 4-week study interval (Week 9 through Week 12)
    - Occurrence of Normal activity, Slight limitation, Moderate limitation, Sick at home, and Bed ridden events as a consequence of vertigo at Week 12
    - SF-36 at Week 12
    o Physical Health Summary Measure
    o Mental Health Summary Measure
    o 8 Scales
    - Il numero di giorni con vertigini oggettive alla settimana 8 [l'intervallo di 4 settimane (28 giorni) dalla settimana 5 alla settimana 8].
    - Il numero di giorni con vertigini oggettive alla settimana 4 [l'intervallo di 4 settimane (28 giorni) dalla settimana 1 alla settimana 4].
    - La variazione, rispetto al basale, nella frequenza delle vertigini (VF) durante l'intervallo di studio di 4 settimane (dalla settimana 9 alla settimana 12), dove la frequenza delle vertigini ¿ definita come la percentuale di giorni durante l'intervallo di 4 settimane in cui ¿ stato registrato un episodio di vertigini oggettive diviso il numero di voci di diario non mancanti per l'intervallo in questione
    - La variazione, rispetto al basale, della gravit¿ degli episodi di vertigini, misurata in base al punteggio medio delle vertigini durante l'intervallo di studio di 4 settimane (dalla settimana 9 alla settimana 12)
    - La variazione, rispetto al basale, del numero medio giornaliero di episodi di vertigini durante l'intervallo di studio di 4 settimane (dalla settimana 9 alla settimana 12)
    - Presenza di attivit¿ normale, limitazione lieve, limitazione moderata, malattia a casa ed eventi che costringono a letto in seguito a vertigini alla settimana 12
    - SF-36 alla settimana 12
    o Misurazione riassuntiva della salute fisica
    o Misurazione riassuntiva della salute mentale
    o 8 scale
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 4, Week 8, Week 12 as specified in the endpoint description.
    Settimana 4, settimana 8, settimana 12 come specificato nella descrizione dell'endpoint
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    LVLS
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    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)
    Subjects who complete all visits in the study will be offered the opportunity to enter an extension study. If they choose not to enter or if they discontinue prematurely, then normal treatment for the condition would be expected.
    Ai soggetti che completano tutte le visite nello studio, verr¿ offerta l'opportunit¿ di entrare in uno studio di estensione. Se i soggetti decidono di non entrare nello studio di estensione o di ritirarsi prematuramente, verranno trattati secondo la normale pratica clinica.
    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 Decision2016-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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