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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc. ( Auris Medical AG )
ClinicalTrials.gov Identifier:
NCT00802425
First received: December 3, 2008
Last updated: June 24, 2014
Last verified: June 2014
  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:


Further study details as provided by Auris Medical, Inc.:

Primary Outcome Measures:
  • Hearing loss [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Days 3, 30, 90 ] [ Designated as safety issue: No ]
    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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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: June 24, 2014
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 August 21, 2014