Back to resultsEfficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss
Primary Purpose
Hearing Loss
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
AM-111
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Sudden hearing loss, Sudden deafness, Acoustic trauma, Noise trauma
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)
Sites / Locations
- LMU Munich Klinikum Grosshadern
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
2
1
3
Arm Description
AM-111 low dose
AM-111 high dose
Outcomes
Primary Outcome Measures
Hearing loss
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
Hearing loss
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00802425
Brief Title
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
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Auris Medical AG
4. Oversight
Data Monitoring Committee
Yes
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Sudden hearing loss, Sudden deafness, Acoustic trauma, Noise trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Experimental
Arm Description
AM-111 low dose
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
3
Arm Type
Experimental
Arm Description
AM-111 high dose
Intervention Type
Drug
Intervention Name(s)
AM-111
Intervention Description
single intratympanic injection
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
single intratympanic injection
Primary Outcome Measure Information:
Title
Hearing loss
Description
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
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Hearing loss
Description
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
Time Frame
Days 3, 30, 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus M Suckfüll, MD
Organizational Affiliation
LMU Munich
Official's Role
Study Director
Facility Information:
Facility Name
LMU Munich Klinikum Grosshadern
City
Munich
ZIP/Postal Code
81366
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss
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