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    EudraCT Number:2018-001464-35
    Sponsor's Protocol Code Number:104-201811
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-17
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    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.
    Studio multicentrico di fase 3, prospettico, randomizzato, in doppio cieco, controllato con placebo, per valutare l’efficacia e la sicurezza di OTO-104 somministrato come singola iniezione intratimpanica in soggetti con malattia di Menière 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.
    Studio per valutare se l'applicazione locale (nell'orecchio) di desametasone (un corticosteroide) potrebbe aiutare ad alleviare i sintomi delle persone affette dalla Malattia di Menière e se l'utilizzo è sicuro.
    A.3.2Name or abbreviated title of the trial where available
    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 number0016193232200
    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 solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPAuricular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 50-02-2
    D.3.9.2Current sponsor codeNA
    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 Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    Malattia di Menière
    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 Malattia di Menière è una malattia dell'orecchio interno. I sintomi sono vertigini (rotazione della stanza), tinnito (ronzio e 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 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).
    Valutare l’efficacia di OTO-104 in soggetti con malattia di Menière, misurata in base al numero di giorni con vertigine definitiva (Definitive Vertigo Day, DVD) alla Settimana 12 (l’intervallo di 4 settimane dalla Settimana 9 alla Settimana 12).
    E.2.2Secondary objectives of the trial
    To investigate the safety profile of OTO-104 in subjects with Meniere's disease.
    Valutare il profilo di sicurezza di OTO-104 in soggetti con malattia di Menière.
    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. Il soggetto è di sesso maschile o femminile di età compresa tra 18 e 75 anni, inclusi.
    2. Il soggetto ha una diagnosi di malattia di Menière unilaterale definita in base ai criteri 1995 dell’AAO-HNS.
    3. Il soggetto riferisce autonomamente episodi di vertigine attiva definitiva nei 2 mesi precedenti il periodo di lead-in dello studio.
    4. Il soggetto presenta perdita asimmetrica dell’udito sensorineurale documentata allo screening o negli ultimi 12 mesi in base ai criteri 1995 dell’AAO-HNS, definita come una delle seguenti condizioni:
    a. la media aritmetica delle soglie di udito (media dei toni puri (Pure Tone Average, PTA)) a 250, 500 e 1.000 Hz è di almeno 15 dB più alta della PTA di 1.000, 2.000 e 3.000 Hz;
    b. la media aritmetica della PTA a 500, 1.000, 2.000 e 3.000 Hz è di almeno 20 dB più bassa nell’orecchio in questione rispetto al lato opposto;
    c. lo sperimentatore ritiene che la perdita dell’udito del soggetto soddisfa i criteri audiometrici plausibili di perdita dell’udito caratteristica della malattia di Menière e, in tal caso, deve essere giustificata, documentata e discussa con il responsabile del monitoraggio medico.
    5. In caso di assunzione di farmaci per la malattia di Menière (es. diuretici, soppressori vestibolari, betaistina, antidepressivi o ansiolitici), il soggetto deve aver assunto dosi stabili del farmaco per almeno 2 settimane prima dello screening e deve acconsentire a continuare ad assumere dosi stabili del farmaco per l’intera durata dello studio.
    6. I soggetti di sesso femminile in età fertile [ovvero, non chirurgicamente sterili e/o non in post-menopausa (=12 mesi dall’ultimo ciclo mestruale e di almeno 45 anni di età)] devono risultare negativi al test di gravidanza sulle urine prima dell’arruolamento. Le donne in età fertile che non si astengono dai rapporti sessuali con i propri partner possono essere incluse nello studio se fanno uso di e sono disposte a continuare a usare precauzioni contraccettive altamente efficaci o “a doppia barriera” per la durata dello studio (es. contraccettivi ormonali, impianto o iniezione di contraccettivi, dispositivo intrauterino o metodi “a doppia barriera” compresi preservativo con diaframma, preservativo maschile con cappuccio cervicale, preservativo maschile con spermicida o diaframma e spermicida).
    7. Il soggetto è disposto ad attenersi al protocollo e a presentarsi a tutte le visite dello studio.
    8. Il soggetto è in grado di usare il telefono per compilare il diario giornaliero.
    9. Il soggetto è in grado di fornire il consenso informato scritto, compresa l’approvazione del testo sulla gravidanza conformemente ai requisiti nazionali e/o locali, prima di iniziare qualsiasi procedura correlata allo studio.
    Al completamento dei primi 28 giorni del periodo di lead-in:
    10. Il soggetto deve aver manifestato e documentato almeno 4 e non oltre 22 giorni di vertigine definitiva durante il periodo di lead-in di 4 settimane.
    11. Il soggetto deve aver completato almeno 22 delle 28 voci del diario durante il periodo di lead-in di 4 settimane.
    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. Il soggetto presenta un’infezione a livello di orecchio, seni nasali o vie respiratorie superiori al momento della randomizzazione.
    2. Il soggetto è in stato di gravidanza o sta allattando al seno.
    3. Il soggetto presenta un’anamnesi di malattia da immunodeficienza.
    4. Il soggetto presenta una malattia dell’orecchio medio attiva o recente (<1 mese prima dello screening), comprese, senza limitazione: otite media cronica, otite media acuta, effusioni dell’orecchio medio, atelettasia o colesteatoma dell’orecchio medio.
    5. Il soggetto presenta un’anomalia della membrana timpanica nell’orecchio affetto che comporterebbe un aumento del rischio associato all’iniezione intratimpanica, compresa, senza limitazione, la membrana timpanica monomerica.
    6. Il soggetto presenta un’anamnesi di intervento chirurgico significativo sull’orecchio medio o dell’orecchio interno, oppure di intervento chirurgico sul sacco endolinfatico nell’orecchio affetto.
    7. Il soggetto presenta un’anamnesi di uso pregresso di gentamicina intratimpanica nell’orecchio affetto.
    8. Il soggetto presenta un’anamnesi di tubi per timpanostomia con evidenza di perforazione o mancata chiusura nell’orecchio affetto.
    9. Il soggetto ha fatto uso di steroidi sistemici entro 1 mese precedente l’ingresso nel periodo di lead-in.
    10. Il soggetto presenta un’anamnesi di uso pregresso di steroidi intratimpanici nell’orecchio affetto.
    11. Il soggetto ha manifestato una reazione avversa al desametasone.
    12. Il soggetto presenta un’anamnesi di emicrania vestibolare. I criteri della Classificazione internazionale dei disturbi della cefalea III per l’emicrania vestibolare includono un’anamnesi attuale o pregressa di emicrania con o senza aura, sintomi vestibolari di intensità moderata o grave della durata compresa tra 5 minuti e 72 ore e almeno metà degli episodi sono associati ad almeno 1 delle seguenti 4 caratteristiche emicraniche: cefalea unilaterale, qualità pulsante, fotofobia e aura visiva.
    13. Il soggetto presenta un’anamnesi di attacchi con caduta.
    14. Il soggetto non è in grado di identificare e riportare accuratamente gli episodi di vertigine.
    15. Il soggetto presenta una qualsiasi altra malattia, condizione medica o anamnesi medica clinicamente significativa che, secondo il parere dello sperimentatore o del responsabile del monitoraggio medico, impedirebbe al soggetto di partecipare allo studio al momento dello screening o della randomizzazione.
    16. Il soggetto ha fatto uso di un farmaco o dispositivo sperimentale nei 3 mesi precedenti lo screening.
    17. Il soggetto presenta un’anamnesi di forte abuso di sostanze (es. cocaina, eroina) nei 6 mesi precedenti lo screening.
    18. Il soggetto è stato precedentemente randomizzato a uno studio clinico di 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.
    il numero di giorni con vertigine definitiva (DVD) alla Settimana 12 [l’intervallo di 4 settimane (28 giorni) dalla Settimana 9 alla Settimana 12]. Un DVD è definito come un giorno in cui il soggetto ha documentato almeno un episodio di vertigine della durata di almeno 20 minuti e corrisponde a un Punteggio della gravità delle vertigini pari a 2 o più.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Settimana 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]
    • Gravità degli episodi di vertigine misurata in base alla media del Punteggio delle vertigini alla Settimana 12 [l’intervallo di 4 settimane (28 giorni) dalla Settimana 9 alla Settimana 12]
    • Il numero di giorni di malattia a casa o costretti a letto a seguito della vertigine alla Settimana 12 [l’intervallo di 4 settimane (28 giorni) dalla Settimana 9 alla Settimana 12]
    • La variazione rispetto al basale nella frequenza delle vertigini (Vertigo Frequency, VF) alla Settimana 12 [l’intervallo di 4 settimane (28 giorni) dalla Settimana 9 alla Settimana 12], dove la frequenza delle vertigini è definita come la percentuale di giorni durante l’intervallo di 4 settimane in cui è stato documentato un episodio di vertigine definitiva diviso per il numero di registrazioni non mancanti nel diario per il relativo intervallo
    • Conteggio medio giornaliero degli episodi di vertigine alla Settimana 12 [l’intervallo di 4 settimane (28 giorni) dalla Settimana 9 alla Settimana 12]
    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 degli endopoint
    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 Information not present in EudraCT
    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 States
    United Kingdom
    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
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 180
    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 Decision2019-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
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