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

NCT ID: NCT00802425

Last Updated: 2014-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2012-10-31

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).

Conditions

Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

2

AM-111 low dose

Group Type: EXPERIMENTAL

AM-111

Intervention Type: DRUG

single intratympanic injection

1

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

single intratympanic injection

3

AM-111 high dose

Group Type: EXPERIMENTAL

AM-111

Intervention Type: DRUG

single intratympanic injection

Interventions

AM-111

single intratympanic injection

Intervention Type: DRUG

placebo

single intratympanic injection

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Auris Medical AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markus M Suckfüll, MD

Role: STUDY_DIRECTOR

LMU Munich

Locations

LMU Munich Klinikum Grosshadern

Munich, , Germany

Countries

Germany

Other Identifiers

EudraCT number 2008-000132-40

Identifier Type: -

Identifier Source: secondary_id

AM-111-CL-08-01

Identifier Type: -

Identifier Source: org_study_id