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 2Lead Sponsor
Auris MedicalStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Hearing LossIntervention/Treatment
hyaluronic acid ...Study Participants
210The 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).
single intratympanic injection
single intratympanic injection
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)
