Trial record 2 of 3 for:    "congenital deafness with labyrinthine aplasia, microtia, and microdontia" [DISEASE] OR NCT00023049 [ID-NUMBER] OR NCT00400413 [ID-NUMBER] OR NCT00802425 [ID-NUMBER]

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: January 29, 2013
Last verified: January 2013
  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:
  • 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
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: 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 April 16, 2014