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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00802425
Recruitment Status : Completed
First Posted : December 4, 2008
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc. ( Auris Medical AG )

Study Description
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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
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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

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Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802425


Locations
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Germany
LMU Munich Klinikum Grosshadern
Munich, Germany, 81366
Sponsors and Collaborators
Auris Medical AG
Investigators
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Study Director: Markus M Suckfüll, MD LMU Munich
More Information
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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    Key Record Dates
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:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases