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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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).

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

Details

• Lead Sponsor: Auris Medical AG

Criteria

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)