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

Sponsor:	Auris Medical AG
Information provided by (Responsible Party):	Auris Medical, Inc. ( Auris Medical AG )
ClinicalTrials.gov Identifier:	NCT00802425

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 II

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: 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 ]

Estimated Enrollment:	204
Study Start Date:	December 2008
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	March 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802425

Contacts

Contact: Thomas Meyer

+41 61 201 1350

ear@aurismedical.com

Locations

Germany
LMU Munich Klinikum Grosshadern	Recruiting
Munich, Germany, 81366
Contact: Markus M Suckfüll, MD +49 89 7095 ext 2879 Markus.Suckfuell@med.uni-muenchen.de

Sponsors and Collaborators

Auris Medical AG

Investigators

Study Director:

Markus M Suckfüll, MD

LMU Munich

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:	August 30, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

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 February 09, 2012