Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss
This study has been completed.
Sponsor:
Auris Medical AG
Information provided by (Responsible Party):
Auris Medical, Inc. ( Auris Medical AG )
ClinicalTrials.gov Identifier:
NCT00802425
First received: December 3, 2008
Last updated: January 29, 2013
Last verified: January 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hearing Loss |
Drug: AM-111 Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
congenital deafness with labyrinthine aplasia, microtia, and microdontia
nonsyndromic deafness
Pendred syndrome
MedlinePlus related topics:
Hearing Disorders and Deafness
U.S. FDA Resources
Further study details as provided by Auris Medical, Inc.:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 210 |
| Study Start Date: | December 2008 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| 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 More Information
No publications provided
| Responsible Party: | Auris Medical, Inc. ( Auris Medical AG ) |
| ClinicalTrials.gov Identifier: | NCT00802425 History of Changes |
| Other Study ID Numbers: | AM-111-CL-08-01, EudraCT number 2008-000132-40 |
| Study First Received: | December 3, 2008 |
| Last Updated: | January 29, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Poland: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Czech Republik: State Institute for Drug Control |
Keywords provided by Auris Medical, Inc.:
|
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 |
ClinicalTrials.gov processed this record on May 23, 2013