Hearing Loss
Conditions
Keywords
Sudden hearing loss, Sudden deafness, Acoustic trauma, Noise trauma
Brief summary
The purpose of the study is to determine whether AM-111 is effective in the treatment of acute inner ear hearing loss (acute sensorineural hearing loss, ASNHL).
Interventions
DRUGAM-111
single intratympanic injection
DRUGplacebo
single intratympanic injection
Sponsors
Auris Medical AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with unilateral acute sensorineural hearing loss (ASNHL) with onset 48 hours or less ago * Mean earing loss compared with the unaffected contralateral ear of at least 30 dB in the 3 most affected contiguous frequencies * Age ≥ 18 years and ≤ 60 years * Negative pregnancy test for women of childbearing potential * Able to attend the on-study visits * Written informed consent before participation in the study
Exclusion criteria
* Bilateral ASNHL, if not resulting from acoustic trauma * Suspected perilymph fistula or membrane rupture * Barotrauma * Average air bone gap higher than 20 dB in 3 contiguous frequencies * History of Meniere disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops, suspected retro-cochlear lesion or fluctuating hearing loss * Previous ASNHL incident within the past 6 weeks * Evidence of acute or chronic otitis media or otitis externa on examination * Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 2 weeks * Any ongoing or planned concomitant medication for the treatment of tinnitus until 30 days after administration * Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics, quinine etc.) in the past 6 months prior to study inclusion * History of drug abuse or alcoholism * Any clinically relevant respiratory, cardiovascular, neurological (except vertigo or tinnitus), or psychiatric disorders * Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction * Women who are breast-feeding, pregnant or who plan a pregnancy during the trial * Women of childbearing potential who declare being unwilling or unable to practice contraception such as combined oral contraceptives, injectables, hormonal intra-uterine devices, vasectomised partner or sexual abstinence * Concurrent participation in another clinical trial or participation in another clinical trial within 30 days prior to study entry * Any current anticoagulant therapy (e.g. Aspirin, Marcumar, etc)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hearing loss | 7 days | Average change in hearing loss in dB between the baseline and D7 for the three contiguous frequencies with the worst hearing loss, identified at study entry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hearing loss | Days 3, 30, 90 | Average change in hearing loss in dB between the baseline and D3, D30, and D90 for the three contiguous frequencies with the worst hearing loss, identified at study entry |
Countries
Germany
Outcome results
None listed