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

Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Dose-Escalation Phase II Study

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).

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Drug: AM-111; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 81366
    • LMU Munich Klinikum Grosshadern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1	Drug: placebo; single intratympanic injection
Experimental: 2; AM-111 low dose	Drug: AM-111; single intratympanic injection
Experimental: 3; AM-111 high dose	Drug: AM-111; single intratympanic injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Auris Medical AG
• Investigators: Study Director: Markus M Suckfüll, MD, LMU Munich

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: December 3, 2008
• First Submitted That Met QC Criteria: December 3, 2008
• First Posted (Estimate): December 4, 2008

Study Record Updates

• Last Update Posted (Estimate): June 26, 2014
• Last Update Submitted That Met QC Criteria: June 24, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Sudden hearing loss; Acoustic trauma; Sudden deafness; Noise trauma
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: AM-111-CL-08-01; EudraCT number 2008-000132-40