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

Phase 2

Completed

• Conditions: Hearing Loss
• Interventions: Drug: AM-111; Drug: placebo

• Registration Number: NCT00802425
• Lead Sponsor: Auris Medical AG

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-03
• Study First Submitted QC: 2008-12-03
• Study First Posted: 2008-12-04
• Primary Completion: 2012-07
• Study Completion: 2012-10
• Disposition First Submitted: 2013-01-29
• Disposition First Submitted QC: 2013-01-29
• Disposition First Posted: 2013-01-31
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-24
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	AM-111	AM-111 low dose
1	placebo	-
3	AM-111	AM-111 high dose

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

LMU Munich Klinikum Grosshadern; 🇩🇪 Munich, Germany