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-DE
• Lead Sponsor: Auris Medical AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-22
• Last Update Posted: 5 August 2013

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)
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is the evaluation of the therapeutic benefit of a single intratympanic AM 111 injection in comparison to placebo in the treatment of acute sensorineural hearing loss (ASNHL);Secondary Objective: The secondary objectives of the study are (a) the confirmation of the safety and local tolerance of intratympanic AM 111 injection and (b) identification of the optimal dose of AM-111 in the treatment of ASNHL;Primary end point(s): •The absolute improvement of PTA given in dB between D0 and D7 based on the average of the three most affected contiguous frequencies<br><br>•Number of patients with clinical significant hearing loss in the treated ear at D7