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

Auris Medical

Status and phase: Completed; Phase 2

Conditions: Hearing Loss

Treatments: Drug: placebo; Drug: AM-111

Study type: Interventional

Funder types: Industry

Identifiers

NCT00802425

AM-111-CL-08-01

EudraCT number 2008-000132-40

Details and patient eligibility

About

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).

Enrollment: 210 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 3 patient groups, including a placebo group

2

Experimental group

Description:

AM-111 low dose

Treatment:

Drug: AM-111

1

Placebo Comparator group

Treatment:

Drug: placebo

3

Experimental group

Description:

AM-111 high dose

Treatment:

Drug: AM-111