Clinical trial NCT00802425: Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hearing Loss
Keywords: Sudden hearing loss
Sudden deafness
Acoustic trauma
Noise trauma
Lead sponsor: Auris Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-04
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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)

Primary outcomes:
measure: Hearing loss
timeFrame: 7 days
Secondary outcomes:
measure: Hearing loss
timeFrame: Days 3, 30, 90
Other outcomes:
Locations:
city: Munich
country: Germany
facility: LMU Munich Klinikum Grosshadern
Study officials:
affiliation: LMU Munich
name: Markus M Suckfüll, MD
role: STUDY_DIRECTOR
References: