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    Summary
    EudraCT Number:2016-000766-29
    Sponsor's Protocol Code Number:104-201610
    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:2021-01-20
    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 number2016-000766-29
    A.3Full title of the trial
    A 6-month, multicenter, Phase 3, open-label extension safety study of OTO-104 given at 3-month intervals by intratympanic injection in subjects with unilateral Meniere¿s disease.
    Studio di estensione, multicentrico, di fase 3, in aperto, della durata di 6 mesi, sulla sicurezza di OTO-104 somministrato ad intervalli di 3 mesi mediante iniezione intratimpanica in soggetti con sindrome di M¿ni¿re monolaterale.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 study of OTO-104 intratympanic injections in subjects with Meniere's disease.
    Studio di Fase 3 di iniezioni intratimpaniche di OTO-104 in soggetti con sindrome di M¿ni¿re.
    A.3.2Name or abbreviated title of the trial where available
    A 6-month, multicenter, Phase 3, open-label extension safety study of OTO-104 given at 3-month inter
    Studio di estensione, multicentrico, di fase 3, in aperto, della durata di 6 mesi, sulla sicurezza d
    A.4.1Sponsor's protocol code number104-201610
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02768662
    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 pointBarbara M. Finn - Vice President, R
    B.5.3 Address:
    B.5.3.1Street Address4796 Executive Drive
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92121
    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 IMPIntratympanic use (Noncurrent)
    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 code/
    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
    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 M¿ni¿re.
    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 M¿ni¿re ¿ una malattia dell¿orecchio interno. I sintomi sono: vertigini (sensazione di rotazione dell¿ambiente ciscostante), tinnito (suono nelle orecchie o sensazione di pienezza nelle
    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
    The objective is to assess the safety of repeat intratympanic injections of 12 mg OTO-104 at 3-month intervals in an open-label study in subjects with unilateral Meniere's disease.
    L'obiettivo ¿ quello di valutare la sicurezza di iniezioni intratimpaniche ripetute di 12 mg di OTO-104 ad intervalli di 3 mesi, in uno studio in aperto intratimpanica in soggetti con sindrome di M¿ni¿re monolaterale.
    E.2.2Secondary objectives of the trial
    N/A
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is a male or female aged 18 years or older.
    2. Subject has completed the Phase 2 (104-201403) or Phase 3 (104-201508) clinical study.
    3. Female subjects of childbearing potential [i.e., not surgically sterile and/or not post-menopausal (12 months since last menstrual period and 45 years of age or older)] must have a negative urine pregnancy test before enrollment. 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, or "double barrier" methods including condom with diaphragm, male condom with cervical cap, male condom with spermicide, or diaphragm and spermicide).
    4. Subject is willing to comply with the protocol and attend all study visits.
    5. Subject is able to provide written informed consent, including agreement to local privacy language requirements either within the informed consent or in ancillary documents compliant with local privacy laws before the initiation of any study-related procedures.
    1. Soggetto di sesso maschile o femminile maggiorenne.
    2. Il soggetto ha completato lo studio clinico di fase 2 (104-201403) o di fase 3 (104-201508).
    3. I soggetti di sesso femminile in età fertile [ossia non chirurgicamente sterili e/o non in post-menopausa (=12 mesi dall'ultima mestruazione e di età uguale o superiore a 45 anni)] devono effettuare un test di gravidanza urinario che deve risultare negativo prima dell'arruolamento. Le donne in età fertile che non si astengono dai rapporti sessuali con partner di sesso maschile possono essere ammesse allo studio se utilizzano, e sono disposte a continuare ad utilizzare, metodi contraccettivi a elevata efficacia o a “doppia barriera” per tutta la durata dello studio (ad es., contraccettivi orali, iniezione o impianto contraccettivo, dispositivo intrauterino o metodi a “doppia barriera”, tra cui profilattico associato a diaframma, profilattico associato a cappuccio cervicale, profilattico con spermicida o diaframma e spermicida).
    4. Il soggetto è disponibile a rispettare il protocollo ed a sottoporsi a tutte le visite di studio.
    5. Il soggetto è in grado di fornire il consenso informato scritto, compresa l'accettazione dei requisiti locali dell'informativa sulla privacy inclusi nel consenso informato o nei documenti complementari in conformità alle leggi locali sulla privacy prima dell'inizio di tutte le procedure correlate allo studio.
    E.4Principal exclusion criteria
    1. Subject has an infection in the ear, sinuses, or upper respiratory system.
    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 affectedear that would increase the risk associated with intratympanic injection including but not limited to a monomeric, atelectatic or atrophic tympanic membrane.
    6. Subject has a history of tympanostomy tubes that includes evidence of perforation or lack of closure.
    7. Subject has a history of previous endolymphatic sac surgery.
    8. Subject has a history of previous use of intratympanic gentamicin in the affected ear.
    9. Subject has history of drop attacks.
    10. Subject has used systemic steroids within 1 month prior to Visit 1.
    11. Subject has had intratympanic steroids within 1 month prior to Visit 1.
    12. Subject has experienced an adverse reaction to intratympanic injection of steroids.
    13. Subject has a hypersensitivity to dexamethasone or any of the excipients in OTO-104.
    14. Subject has any other clinically significant illness or medical condition that, in the investigator's and the medical monitor's opinion, would prohibit the subject from participating in the study.
    15. Subject has participated in a clinical trial within 30 days of Visit 1, not including the OTO-104 Phase 3 study (104-201508).
    1. Il soggetto ha una infezione in atto a carico dell'orecchio, dei seni o dell'apparato respiratorio superiore.
    2. Il soggetto è in stato di gravidanza o allattamento.
    3. Il soggetto ha una anamnesi di malattia da immunodeficienza.
    4. Il soggetto ha patologie dell'orecchio medio attive o recenti (<1 mese prima dello screening), inclusi, a titolo esemplificativo e non esaustivo: otite media cronica, otite media acuta, otite media con effusione, atelettasia dell'orecchio medio o colesteatoma.
    5. Il soggetto presenta anormalità 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, atelettatsca o atrofica.
    6. Il soggetto ha una anamnesi di posizionamento di tubi di drenaggio dopo timpanostomia con evidenza di perforazione o mancata chiusura.
    7. Il soggetto ha una anamnesi di precedente intervento chirurgico sul sacco endolinfatico.
    8. Il soggetto ha una anamnesi di precedente utilizzo di gentamicina intratimpanica nell'orecchio interessato.
    9. Il soggetto ha una anamnesi di attacchi con caduta.
    10. Il soggetto ha utilizzato corticosteroidi sistemici nel mese precedente alla Visita 1.
    11. Il soggetto ha ricevuto corticosteroidi intratimpanici nel mese precedente alla Visita 1.
    12. Il soggetto ha avuto una reazione avversa all'iniezione intratimpanica di corticosteroidi.
    13. Il soggetto ha ipersensibilità al desametasone o a qualsiasi eccipiente contenuto in OTO-104.
    14. Il soggetto presenta un’altra malattia o condizione medica, clinicamente significativa, che, a parere dello sperimentatore o del monitor medico, impedirebbe al soggetto di partecipare allo studio.
    15. Il soggetto ha partecipato ad una sperimentazione clinica entro trenta giorni dalla Visita 1, escluso lo studio di fase 3 su OTO-104 (104-201508).
    E.5 End points
    E.5.1Primary end point(s)
    - Adverse events
    - Audiometry assessments
    - Tympanometry
    - Local tolerability (otoscopic examinations)
    - Suicide ideation assessment
    - Vital signs measurements
    - Concomitant medications
    - Eventi Avversi
    - Valutazioni audiometriche
    - Timpanometria
    - Tollerabilità locale (esami otoscopici)
    - Valutazione dell'ideazione suicidaria
    - Misurazioni dei segni vitali
    - Trattamenti concomitanti
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse events - continuous from first injection.
    The following are captured at Day 1, Month 3, Month 6:
    - Audiometry assessments
    - Tympanometry
    - Local tolerability (otoscopic examinations)
    - Suicide ideation assessment
    - Vital signs measurements
    - Concomitant medications
    Eventi Avversi - continuativamente a partire dalla prima iniezione
    I seguenti end point saranno rilevati al Giorno 1, Mese 3 e Mese 6:
    - Valutazioni audiometriche
    - Timpanometria
    - Tollerabilità locale (esami otoscopici)
    - Valutazione dell'ideazione suicidaria
    - Misurazioni dei segni vitali
    - Trattamenti concomitanti
    E.5.2Secondary end point(s)
    Global vertigo, tinnitus, subjective hearing and aural fullness change questions.
    Vertigini globali, tinnito, udito soggettivo e domande sulla variazione della pienezza auricolare.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, Month 3, Month 6.
    Giorno 1, Mese 3, Mese 6.
    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 No
    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 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 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 months2
    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 months5
    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: 225
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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.
    Nessuno.
    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 Decision2016-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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