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

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Auris Medical AG

Criteria

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.