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    Summary
    EudraCT Number:2018-000812-47
    Sponsor's Protocol Code Number:SENS401-201
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-28
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2018-000812-47
    A.3Full title of the trial
    A two- part, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of SENS-401 in subjects with severe or profound sudden sensorineural hearing loss
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the use of SENS-401 in subjects with sudden deafness
    A.3.2Name or abbreviated title of the trial where available
    AUDIBLE-S
    A.4.1Sponsor's protocol code numberSENS401-201
    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 SponsorSENSORION SA
    B.1.3.4CountryFrance
    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 supportSENSORION SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSENSORION SA
    B.5.2Functional name of contact pointSerge Fitoussi
    B.5.3 Address:
    B.5.3.1Street Address375 rue du Professeur Joseph Blayac
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post code34080
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 698372309
    B.5.6E-mailserge.fitoussi@sensorion-pharma.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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/114/16
    D.3 Description of the IMP
    D.3.1Product nameSENS-401 ((R)-azasetron besylate)
    D.3.2Product code SENS-401
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.1CAS number 2025360-91-0
    D.3.9.2Current sponsor codeSENS-401
    D.3.9.3Other descriptive nameCML1882, (R)-Azasetron besylate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sudden sensorineural hearing loss (SSNHL)
    E.1.1.1Medical condition in easily understood language
    Sudden deafness
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10040016
    E.1.2Term Sensorineural hearing loss
    E.1.2System Organ Class 100000004854
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of SENS-401 on hearing loss in comparison to placebo at the end of the 4-week treatment period.
    E.2.2Secondary objectives of the trial
    To confirm the maintenance of any early efficacy on hearing loss at 12-week
    To evaluate the efficacy on tinnitus
    To determine the dose effect on hearing loss
    To confirm the safety of SENS-401 in the studied population/dosage regimen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Male or female
    2 Aged at least 18 years old
    3 Patients with unilateral idiopathic sudden sensorineural hearing loss or unilateral/bilateral acute acoustic trauma leading to sudden
    sensorineural hearing loss defined by both
    • 3.1. At least 1 hearing threshold of 50 dB or more amongst the 3 most affected contiguous frequencies on pure tone audiometric air conduction
    testing performed 24 hours or less prior to first study treatment,
    and
    • 3.2. Mean hearing loss of 30 dB or more, averaged across the air conducted PTA frequencies (“pure tone audiometry”, PTA performed 24 hours or less prior to first study treatment), compared with the unaffected contralateral ear or reference values from a pre-existing audiogram (dated less than 2 years) or ISO 7029:2017 norm values in case of asymmetric hearing prior to the ISSNHL incident
    4 Patients with sudden hearing loss with onset within 96 hours prior to first study drug intake.
    5 Females must meet one of the following: postmenopausal defined as 12 consecutive months with no menses without an alternative medical cause, surgically sterile, abstinent; or practicing highly effective birth control (must agree to use 2 forms of contraception [1 of which must be a barrier method]) (Appendix 4) and willing to continue to use highly effective contraception for the duration of study participation and for 30 days after the final dose of study drug). Women of childbearing potential must have a negative pregnancy test at screening before the first dose of study drug is taken. Women of childbearing potential are defined as any female who has experienced menarche and who is not permanently sterile or postmenopausal.
    6 Male subjects and their female partner(s) must agree to use highly effective contraception (must agree to use 2 forms of contraception [1 of which must be a barrier method]) (Appendix 4) for the duration of study participation and for 90 days after the final dose of study drug.
    7 Signed and dated written informed consent.
    E.4Principal exclusion criteria
    1.Bilateral idiopathic hearing loss
    2.Fluctuating hearing loss
    3.History of asymetric hearing (>20dB difference between ears) to the best knowledge of the patient
    4.Severe hearing loss (>90 dB) associated with unilateral (ipsilateral) complete vestibular loss
    5.History of Ménière’s disease, autoimmune hearing loss, radiation-induced hearing loss, acoustic neuroma (schwannoma)
    6.Previous SSNHL in the affected ear within the past 6 weeks
    7.History of otosclerosis, suspected perilymph fistula or membrane rupture, suspected retro-cochlear lesion, barotrauma
    8.Congenital or hereditary hearing loss
    9. History of severe head or neck trauma
    10. Complete loss of peripheral vestibular function on the affected side
    11. Any drug-based therapy for inner ear hearing loss that is ongoing or
    was performed in the past 6 weeks, except oral corticosteroids
    12. Any ongoing or planned concomitant medication for the treatment
    of tinnitus until 6 weeks after administration
    13. Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin,
    loop diuretics, quinine etc.) at the current time or in the past 6 months
    prior to study inclusion
    14. Air-bone gap of greater than 20 dB in 3 contiguous frequencies
    15. Acute chronic otitis media or otitis externa terminated less than 7
    days prior to randomisation.
    16. History of chronic inflammatory or suppurative ear disease or
    cholesteatoma,
    17. Prior ear surgery of any kind (except ventilating tubes), or cochlear
    implants
    18. Patients with moderate to severe renal impairment defined by a
    creatinine clearance ≤ 60 ml/min (calculated with the Cockroft-Gault
    formula (for patients < 65 years old and with CKD-EPI creatinine equation or with MDRD equation for patients ≥ 65 years old.)
    19. Treatment with triptans within the 24 hours before inclusion.
    20. History of drug abuse or alcoholism within the last 2 years
    21. Known or suspected ongoing active infection of HIV, Hepatitis B or
    C, or herpes zoster
    22. Known history of, or concomitant severe hepatic, gastrointestinal,
    cardiovascular, respiratory, neurological (except vertigo or tinnitus),
    hematological, renal, dermatological or psychiatric disease or substance
    abuse or any condition that, in the opinion of the Investigator might
    interfere with the evaluation of study treatment or warrant exclusion (see list of discontinuation criteria, section 11.3.2)
    23. Patients who, in the opinion of the Investigator, have any clinically
    relevant findings that warrant exclusion. Examples of clinically relevant
    problems include, but are not limited to, serious non-malignancyassociated
    medical conditions that may be expected to limit life
    expectancy or significantly increase the risk of SAEs and any condition,
    psychiatric, substance abuse, or otherwise, that, in the opinion of the
    Investigator, would preclude informed consent, consistent follow-up, or
    compliance with any aspect of the study
    24. Neurological disorders including stroke, demyelinating disease,
    brain stem or cerebellar dysfunction within the last 3 months. (In case
    of possible stroke of the brainstem or cerebellum, or demyelinating
    disease the diagnosis should have been excluded by a MRI performed in
    the past 48 hours)
    25. Known hypersensitivity, allergy or intolerance to the study
    medication or any history of severe abnormal drug reaction
    26. Pregnant or breast-feeding
    27. Mentally unable to understand the nature, objectives and possible
    consequences of the trial, or refusing its constraints
    28. Treatment with any investigational agent within 4 weeks prior to
    randomisation or 5 half-lives of the investigational drug (whichever is
    longer)
    29. Prior participation in a clinical trial with SENS-401 or any past
    treatment with azasetron
    30. Patient is the Investigator or any Sub-Investigator, research
    assistant, pharmacist, study coordinator, other staff or relative thereof
    directly involved in the conduct of the protocol
    31. Patients with either a history of significant arrhythmia, or a history
    of conditions known to increase the proarrhythmic risk (e.g., congestive
    heart failure, long QT Syndrome, hypokalemia etc...).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change in pure tone audiometry (PTA); average of the hearing threshold of 3 contiguous most affected hearing frequencies in decibels as identified at study entry) in the affected ear from baseline to the end of treatment visit (Visit D28± 3).
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline, Visit D28± 3
    E.5.2Secondary end point(s)
    • Change in pure tone audiometry (average of the hearing threshold of
    the 2 most affected hearing frequencies identified at study entry) in
    affected ear from baseline to the end of treatment visit (Visit D28± 3).
    • Change in pure tone audiometry (the most affected hearing
    frequencies identified at study entry) in affected ear from baseline to the
    end of treatment visit (Visit D28± 3).
    •Change in speech discrimination threshold from baseline to Days 28, and 84

    •Frequency and severity of tinnitus at Days 7, 14, 28 and 84
    E.5.2.1Timepoint(s) of evaluation of this end point
    • baseline to Days 28, and 84
    • Days 7, 14, 28, and 84
    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 Yes
    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) 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 trial3
    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 EEA29
    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
    Canada
    Israel
    Serbia
    Turkey
    Bulgaria
    France
    Germany
    Poland
    Slovakia
    United Kingdom
    Czechia
    E.8.7Trial has a data monitoring committee Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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: 181
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 Yes
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 276
    F.4.2.2In the whole clinical trial 301
    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)
    Patient will return to standard of care
    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 Decision2018-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-01-12
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