Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss

• AM-111 (Drug): single intratympanic injection
• placebo (Drug): single intratympanic injection

Primary outcomes

• 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 outcomes

• 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

Sex: All, ages: 18 Years to 60 Years

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)

• Markus M Suckfüll, MD, Study director, LMU Munich