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: Acute sensorineural hearing loss (ASNHL), which may be triggered by acoustic trauma, middle or inner ear surgery, i.e. known or evident insults to the inner ear. ASNHL may also result from a variety of other insults such as bacterial or viral infections, inflammation, vascular compromise, autoimmune disorders or mechanical damage, which may not be directly observable.
MedDRA version: 14.1Level: LLTClassification code 10040016Term: Sensorineural hearing lossSystem Organ Class: 10013993 - Ear and labyrinth disorders

Registration Number: EUCTR2008-000132-40-CZ

Lead Sponsor: Auris Medical AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 204

Inclusion Criteria

•Patients with unilateral acute sensorineural hearing loss (ASNHL) with onset 48 hours or less ago
•Mean hearing 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

* For patients with asymmetric hearing or bilateral ASNHL resulting from acoustic trauma (most affected ear is treated), hearing loss is determined against a pre-existing audiogram (not older than 3 years), or, if no pre-existing audiogram is available, age- and sex-adjusted normative values according to ISO 7029:2000 (Statistical distribution of hearing thresholds as a function of age adjusting for the age-related hearing loss”).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 therapy known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics, quinine etc.) in the past 6 months prior to study inclusion