Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss
Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss
Primary objective of the study is to assess the efficacy of SENS-401 on hearing loss in
 comparison to placebo at the end of the 4-week treatment period
Patients will receive the study drug (SENS-401 or placebo) in the form of tablets by mouth,
 twice a day (3 tablets in the morning and 3 tablets in the evening), during the first 4 weeks
 after randomization.

 SENS-401 is an investigational medicinal product. It belongs to a family of drugs known as "5
 HT3 antagonist".
The main criteria for inclusion:

 -  Male or female aged at least 18 years old

 -  Patients with unilateral idiopathic sudden sensorineural hearing loss or
 unilateral/bilateral acute acoustic trauma leading to sudden sensorineural hearing
 loss.

 -  Patients with sudden hearing loss with onset within 96 hours prior to prior to first
 study drug intake.

 -  Patients under highly effective contraception

 The main criteria for exclusion:

 -  Bilateral idiopathic hearing loss

 -  Fluctuating hearing loss

 -  History of asymmetric hearing (>20 dB difference between ears) to the best knowledge
 of the patient

 -  Severe hearing loss (>90 dB) associated with unilateral (ipsilateral) complete
 vestibular loss.

 -  History of Ménière's disease, autoimmune hearing loss, radiation-induced hearing loss,
 acoustic neuroma (schwannoma), otosclerosis, suspected perilymph fistula or membrane
 rupture, suspected retro-cochlear lesion, or barotrauma

 -  Previous SSNHL in the affected ear within the past 6 weeks

 -  Complete loss of peripheral vestibular function on the affected side

 -  Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in
 the past 6 weeks (except oral corticosteroids)

 -  Any ongoing or planned concomitant medication for the treatment of tinnitus until 6
 weeks after administration.

 -  Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics,
 quinine etc.) at the current time or in the past 6 months or planned in the coming 3
 months.

 -  Acute or chronic otitis media or otitis externa terminated less than 7 days

 -  Prior ear surgery of any kind (except ventilating tubes), or cochlear implants

 -  Known history of, or concomitant severe hepatic, gastrointestinal, cardiovascular,
 respiratory, neurological (except vertigo or tinnitus), hematological, renal,
 dermatological or psychiatric disease or substance abuse

 -  Neurological disorders including stroke, demyelinating disease, brain stem or
 cerebellar dysfunction within the last 3 months.

 -  Treatment with any investigational agent within 4 weeks or any past treatment with
 azasetron or with 5-HT3 antagonists, or any prior or planned treatment by
 antidepressant treatment containing serotoninergic agents.

 -  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...).