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

• ClinicalTrials.gov Identifier: NCT00802425
• Recruitment Status: Completed
• First Posted: December 4, 2008
• Last Update Posted: June 26, 2014
• Sponsor: Auris Medical AG
• Information provided by (Responsible Party): Auris Medical, Inc. ( Auris Medical AG )

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Hearing Loss	Drug: AM-111; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: December 2008
• Actual Primary Completion Date: July 2012
• Actual Study Completion Date: October 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: 2; AM-111 low dose	Drug: AM-111; single intratympanic injection
Placebo Comparator: 1	Drug: placebo; single intratympanic injection
Experimental: 3; AM-111 high dose	Drug: AM-111; single intratympanic injection

Outcome Measures

Primary Outcome Measures :

1. Hearing loss [ Time Frame: 7 days ]
   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

Secondary Outcome Measures :

1. Hearing loss [ Time Frame: Days 3, 30, 90 ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

Germany

LMU Munich Klinikum Grosshadern

Munich, Germany, 81366

Sponsors and Collaborators

Auris Medical AG

Investigators

• Study Director: Markus M Suckfüll, MD; LMU Munich

More Information

• Responsible Party: Auris Medical AG
• ClinicalTrials.gov Identifier: NCT00802425
• Other Study ID Numbers: AM-111-CL-08-01; EudraCT number 2008-000132-40
• First Posted: December 4, 2008
• Last Update Posted: June 26, 2014
• Last Verified: June 2014

Keywords provided by Auris Medical, Inc. ( Auris Medical AG ):

Sudden hearing loss; Sudden deafness; Acoustic trauma; Noise trauma

Additional relevant MeSH terms:

Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms