Status:
COMPLETED
Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss
Lead Sponsor:
Auris Medical AG
Conditions:
Hearing Loss
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00802425
Start Date
December 1 2008
End Date
October 1 2012
Last Update
June 26 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
LMU Munich Klinikum Grosshadern
Munich, Germany, 81366