Sudden sensorineural hearing loss (SSNHL) MedDRA version: 20.0 Level: LLT Classification code 10040016 Term: Sensorineural hearing loss System Organ Class: 100000004854
Conditions
Interventions
Product Name: SENS-401 ((R)-azasetron besylate)
Product Code: SENS-401
Pharmaceutical Form: Tablet
INN or Proposed INN: -
CAS Number: 2025360-91-0
Current Sponsor code: SENS-401
Other descriptive nam
Sponsors
SENSORION SA
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 181 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
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 (except if related to age or chronic noise) 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 demyelinatingdisease 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of SENS-401 on hearing loss in comparison to placebo at the end of the 4-week treatment period.;Secondary Objective: 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 ;Primary 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).;Timepoint(s) of evaluation of this end point: baseline, Visit D28± 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: • baseline to Days 28, and 84 • Days 7, 14, 28, and 84;Secondary 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 | — |
Countries
Bulgaria, Canada, Czechia, Czech Republic, France, Germany, Israel, Poland, Serbia, Slovakia, Turkey, United Kingdom
Contacts
Public ContactSerge Fitoussi
SENSORION SA
Outcome results
None listed