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

Hearing Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802425
• Other study ID #: AM-111-CL-08-01
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 2
• First received: December 3, 2008
• Last updated: June 24, 2014
• Start date: December 2008
• Est. completion date: October 2012

Study information

• Verified date: June 2014
• Source: Auris Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesPoland: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.Czech Republik: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Drug:
• AM-111
single intratympanic injection
• placebo
single intratympanic injection

Locations

Country	Name	City	State
Germany	LMU Munich Klinikum Grosshadern	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Auris Medical AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days	No
Secondary	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	Days 3, 30, 90	No