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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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    EudraCT Number:2018-001464-35
    Sponsor's Protocol Code Number:104-201811
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-18
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-001464-35
    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.
    Estudio multicéntrico de fase III, prospectivo, aleatorizado, doble ciego y controlado con placebo de la eficacia y la seguridad de OTO-104 administrado en inyección intratimpánica única en pacientes con síndrome de Ménière unilateral
    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.
    Estudio par ver si la aplicación local (en el oído) de dexametasona (un corticoesteroide) a personas con enfermedad de Meniere puede mejorar los sintomas y es seguro su uso
    A.4.1Sponsor's protocol code number104-201811
    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 Trial Operations
    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 number16193232200
    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 IMPIntratympanic use (Noncurrent)
    Auricular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 50-02-2
    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 number30
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    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
    Enfermedad de 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 enfermedad de meniere es una enfermedad del oído interno. Los síntomas son vértigo (), tinnitus (zumbido en los oidos o sensación de taponamiento) y pérdida de audición
    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 investigate 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).
    Evaluar la eficacia de OTO-104 en pacientes con síndrome de Ménière, determinada en función del número de días con vértigo definitivo (DVD ) en la Semana 12 (el intervalo de 4 semanas comprendido entre la Semana 9 y la Semana 12).
    E.2.2Secondary objectives of the trial
    To investigate the safety profile of OTO-104 in subjects with Meniere’s disease.
    Evaluar el perfil de seguridad de OTO-104 en pacientes con síndrome de Ménière.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is a male or female aged 18 to 75 years, inclusive.
    2. Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria.
    3. Subject self-reports active, definitive vertigo episodes for the 2 months prior to the study lead-in period.
    4. Subject has documented asymmetric sensorineural hearing loss at screening or within the past 12 months according to 1995 AAO-HNS 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 must be justified and documented, and discussed with the medical monitor.
    5. If taking medication for Meniere’s disease (e.g., diuretics, vestibular suppressants, betahistine, antidepressants, or anxiolytics), subject must be on stable doses of the medication for at least 2 weeks prior to Screening and agrees to remain on stable doses of the medication for the duration of the study.
    6. Female subjects of childbearing potential [i.e., not surgically sterile and/or not postmenopausal (≥12 months since last menstrual period and 45 years of age or older)] must have a negative urine pregnancy test before randomization. Women of childbearing potential who are not abstinent from sex with male partners may be entered into the study if they are using and willing to continue to use highly effective or “double barrier”
    contraceptive precautions for the duration of the study (e.g., oral contraceptives, contraceptive implant or injection, intrauterine device, “double barrier” methods including male condom with diaphragm, male condom with cervical cap, male condom with spermicide, or diaphragm and spermicide).
    7. Subject is willing to comply with the protocol and attend all study visits.
    8. Subject is able to use the telephone to complete their daily diary.
    9. Subject is able to provide written informed consent, including agreement to privacy language compliant with country and/or local requirements, before the initiation of any study-related procedures.

    At the completion of the first 28 days of the lead-in period:
    10. Subject has experienced and recorded at least 4 and a maximum of 22 definitive vertigo days during the 4-week lead-in period.
    11. Subject completed at least 22 of 28 diary entries during the 4-week lead-in period.
    1. El paciente es un a varón o una mujer de entre 18 y 75 años, inclusive.
    2. El paciente tiene un diagnóstico de síndrome de Ménière unilateral manifiesto según los criterios de la AAO-HNS de 1995.
    3. El paciente refiere crisis activas de vértigo manifiesto durante los 2 meses anteriores al periodo de preinclusión del estudio.
    4. El paciente presenta hipoacusia neurosensitiva asimétrica confirmada en el momento del screening o en los 12 meses anteriores según los criterios de la AAO-HNS de 1995:
    a. La media aritmética de los umbrales auditivos (promedio de tonos puros, PTA) a 250, 500 y 1000 Hz supera al menos en 15 dB el PTA de 1000, 2000 y 3000 Hz.
    b.La media aritmética del PTA a 500, 1000, 2000 y 3000 Hz es inferior en 20 dB o más en el oído afectado que en el contralateral.
    c. A criterio del investigador, la audición del paciente satisface criterios audiométricos razonables de la hipoacusia característica del síndrome de Ménière, lo que es necesario justificar y documentar, y debe comentarse con el monitor médico.
    5. Si el paciente toma medicación contra para el síndrome de Ménière (p. ej., diuréticos, inhibidores vestibulares, betahistina, antidepresivos o ansiolíticos), debe haber recibido dosis estables de la medicación durante al menos las 2 semanas anteriores al screening y comprometerse a permanecer con dosis estables durante el transcurso del estudio.
    6. Las mujeres con posibilidades de quedarse embarazadas (es decir, las que no se hayan sometido a una esterilización quirúrgica ni sean posmenopáusicas [≥12 meses desde la última menstruación y 45 años o más]) deben contar con una prueba de embarazo en orina con resultado negativo antes de su inclusión en el estudio.Las mujeres con posibilidades de quedarse embarazadas que no practiquen la abstinencia sexual con varones pueden participar en el estudio si utilizan y tienen intención de seguir utilizando métodos anticonceptivos de alta eficacia o «de doble barrera» durante el transcurso del estudio (p. ej., anticonceptivos orales, implante o inyección anticonceptiva, dispositivo intrauterino o métodos «de doble barrera», como preservativo con diafragma, preservativo masculino con capuchón cervical., preservativo masculino con espermicida o diafragma y espermicida).
    7. El paciente tiene intención de cumplir el protocolo y acudir a todas las visitas del estudio.
    8. El paciente es capaz de usar el teléfono para cumplimentar el diario.
    9. El paciente es capaz de otorgar su consentimiento informado por escrito, que incluye una cláusula de protección de datos de conformidad con los requisitos nacionales o locales, antes de iniciar cualquiera de los procedimientos vinculados con el estudio.

    Una vez transcurridos los primeros 28 días del periodo de preinclusión:
    10. El paciente ha presentado y registrado un mínimo de 4 y un máximo de 22 días con vértigo definitivo durante las 4 semanas del periodo de preinclusión.
    11. El paciente ha cumplimentado al menos 22 de las 28 entradas del diario durante las 4 semanas del periodo de preinclusión.
    E.4Principal exclusion criteria
    1. Subject has an infection in the ear, sinuses, or upper respiratory system at the time of randomization.
    2. Subject is pregnant or lactating.
    3. Subject has a history of immunodeficiency disease.
    4. Subject has active or recent (<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma.
    5. 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.
    6. Subject has a history of significant middle ear or inner ear surgery, or endolymphatic sac surgery in the affected ear.
    7. Subject has a history of previous use of intratympanic gentamicin in the affected ear.
    8. Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure in the affected ear.
    9. Subject has used systemic steroids within 1 month prior to entering the lead-in period.
    10. Subject has a history of previous use of intratympanic steroids in the affected ear.
    11. Subject has experienced an adverse reaction to dexamethasone
    12. Subject has a history of vestibular migraine. International Classification of Headache Disorders III criteria for vestibular migraine includes a current or past history of migraine with or without aura, vestibular symptoms of moderate or severe intensity lasting between 5 minutes and 72 hours, and at least half of episodes are associated with at least 1 of the 4 following migrainous features: unilateral headache, pulsating quality, photophobia, and visual aura.
    13. Subject has history of drop attacks.
    14. Subject is not able to accurately identify and report episodes of vertigo.
    15. Subject has any other clinically significant illness, medical condition, or medical history that, in the Investigator’s or the medical monitor’s opinion, would prohibit the subject from participating in the study at screening or at the time of randomization.
    16. Subject has used an investigational drug or device in the 3 months prior to screening.
    17. Subject has a history of serious substance abuse (e.g. cocaine, heroin) within the preceding 6 months prior to screening.
    18. Subject has previously been randomized to a clinical study of OTO-104.
    1. El paciente presenta una infección en el oído, los senos paranasales o las vías respiratorias altas en el momento de la aleatorización.
    2. La paciente está embarazada o en período de lactancia.
    3. El paciente tiene antecedentes de inmunodeficiencia.
    4. El paciente presenta alguna enfermedad del oído medio activa o reciente (<1 mes antes del screening), como por ejemplo: otitis media crónica, otitis media aguda, otitis media serosa, atelectasias del oído medio o colesteatoma.
    5. El paciente presenta una anomalía de la membrana timpánica en el oído afectado que incrementaría los riesgos asociados con la inyección intratimpánica, como por ejemplo una membrana timpánica monomérica.
    6. El paciente tiene antecedentes quirúrgicos importantes del oído medio o el oído interno, o del saco endolinfático en el oído afectado.
    7. El paciente tiene antecedentes de uso de gentamicina intratimpánica en el oído afectado.
    8. El paciente tiene antecedentes de inserción de tubos de timpanostomía con signos de perforación o ausencia de cierre en el oído afectado.
    9. El paciente ha utilizado corticosteroides sistémicos en el mes anterior a su inclusión en eal periodo de preinclusión.
    10. El paciente tiene antecedentes de uso de corticosteroides intratimpánicos en el oído afectado.
    11. El paciente ha presentado alguna reacción adversa a la dexametasona.
    12. l paciente tiene antecedentes de migraña vestibular. Los criterios para el diagnóstico de migraña vestibular según la tercera edición de la Clasificación Internacional de las Cefaleas incluyen antecedentes de migraña o migraña actual con o sin aura, síntomas vestibulares moderados o intensos que duren entre 5 minutos y 72 horas, y que al menos la mitad de las crisis se acompañen de al menos 1 de las 4 signos migrañosos siguientes: cefalea unilateral, carácter pulsátil, fotofobia y aura visual.
    13. El paciente tiene antecedentes de caídas súbitas.
    14. El paciente no es capaz de identificar y describir con precisión las crisis de vértigo.
    15. El paciente presenta alguna otra enfermedad, trastorno o antecedente médico clínicamente significativos que, según el criterio del investigador o del monitor médico, podría impedir su participación en el estudio en el momento del screening o en el momento de la aleatorización.
    16. El paciente ha utilizado un medicamento o producto sanitario en fase de investigación clínica en los 3 meses anteriores al screening.
    17. El paciente tiene antecedentes de toxicomanía grave (p. ej., cocaína o heroína) en los 6 meses anteriores al screening.
    18. El paciente había sido aleatorizado con anterioridad en un estudio clínico de 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]. Note: A DVD is defined as a day where the subject recorded at least one vertigo episode lasting at least 20 minutes and corresponds to a Vertigo Severity Score of 2 or more.
    El número de días de con vértigo definitivo (DVD) en la Semana 12 (el intervalo de 4 semanas [28 días] comprendido entre la Semana 9 y la Semana 12). Nota: Un DVD es, por definición, un día en el que el paciente haya registrado al menos una crisis de vértigo que dure un mínimo de 20 minutos y que corresponda a una puntuación de la intensidad del vértigo de 2 o más.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Seana 12
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    • Severity of vertigo episodes as measured by the mean Vertigo Score at Week 12 [the 4-week (28-day) interval from Week 9 through Week 12]
    • The number of days Sick at home or Bedridden as a consequence of vertigo at Week 12 [the 4-week (28-day) interval from Week 9 through Week 12]
    • The change from baseline in vertigo frequency (VF) at Week 12 [the 4-week (28-day) interval from 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 non-missing diary entries for the relevant interval
    • Average daily count of vertigo episodes at Week 12 [the 4-week (28-day) interval from Week 9 through Week 12]
    Criterios secundarios de valoración:
    • Intensidad de las crisis de vértigo, determinada mediante la puntuación media del vértigo en la Semana 12 (el intervalo de 4 semanas [28 días] comprendido entre la Semana 9 y la Semana 12).
    • Número de días que se queda en casa o está encamado como consecuencia del vértigo en la Semana 12 (el intervalo de 4 semanas [28 días] comprendido entre la Semana 9 y la Semana 12).
    • Variación con respecto a la situación basal de la frecuencia del vértigo (FV) en la Semana 12 (el intervalo de 4 semanas [28 días] comprendido entre la Semana 9 y la Semana 12), siendo la frecuencia del vértigo, por definición, el porcentaje de días durante el intervalo de 4 semanas en los que se registra una crisis de vértigo definitivo dividido por entre el número de entradas del diario disponibles para el intervalo en cuestión.
    • Promedio del recuento diario de crisis de vértigo en la Semana 12 (el intervalo de 4 semanas [28 días] comprendido entre la Semana 9 y la Semana 12).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 4, Week 8, Week 12 as specified in the endpoint description.
    Semana 4, Semana 8, Semana 12 como se especifica en la descripción de los criterios de valoración
    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. 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    United States
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 130
    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 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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    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)
    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 Decision2019-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-28
    P. End of Trial
    P.End of Trial StatusOngoing
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