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

Study Overview
=================
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).

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

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Drug: AM-111
* Drug: placebo


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>AM-111 low dose | Drug: AM-111<br>* single intratympanic injection<br>|
| Placebo Comparator: 1<br> | Drug: placebo<br>* single intratympanic injection<br>|
| Experimental: 3<br>AM-111 high dose | Drug: AM-111<br>* single intratympanic injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing loss | 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 | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing loss | 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 | Days 3, 30, 90 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sudden hearing loss, Sudden deafness, Acoustic trauma, Noise trauma