Efficacy and Safety of AM-111 in the Treatment of Acute Inner Ear Hearing Loss

AM-111-CL-13-01

The purpose of this research study is to test the effectiveness and safety of the study drug, AM-111. AM-111 is tested for the treatment of sudden sensorineural hearing loss where the cause is unknown.

2015-11-01

2017-09-01

2017-09-01

Completed

Early phase I

256

Inclusion Criteria: 1. Unilateral ISSNHL with onset within 72 hours prior to study treatment; 2. Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across the 3 most affected contiguous air conduction audiometric pure tone frequencies ("pure tone average", PTA);\* 3. Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air conducted PTA frequencies compared with the unaffected contralateral ear or reference values from a pre-existing audiogram or ISO 7029;2000 norm values in case of asymmetric hearing prior to the ISSNHL incident; 4. Age ≥ 18 and ≤ 65 years on the day of screening; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: 1. Bilateral ISSNHL; 2. Acute hearing loss from noise trauma, barotrauma or head trauma; 3. History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière's disease in the affected ear; 4. History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear; 5. History of acoustic neuroma or other retrocochlear damage in the affected ear; 6. History of otosclerosis in the affected ear; 7. Suspected perilymph fistula or membrane rupture in the affected ear; 8. Congenital hearing loss; 9. History of ISSNHL in the past 2 years; 10. Otitis media or otitis externa that is ongoing or ended within 7 days prior to study treatment; Other protocol-defined exclusion criteria may apply.

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2023-09-14