Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss

• Status: Recruiting
• Trial end date: 2022-08-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sensorion

Criteria

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...).