Title

Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss
Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Dose-Escalation Phase II Study
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    am-111 ...
  • Study Participants

    210
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).
Study Started
Dec 31
2008
Primary Completion
Jul 31
2012
Study Completion
Oct 31
2012
Last Update
Jun 26
2014
Estimate

Drug AM-111

single intratympanic injection

Drug placebo

single intratympanic injection

2 Experimental

AM-111 low dose

1 Placebo Comparator

3 Experimental

AM-111 high dose

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)
No Results Posted