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

NCT00802425 | Completed Phase 2 DMC

• 2 other identifiers: AM-111-CL-08-01EudraCT number 2008-000132-40
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hearing Loss

Keywords

Sudden hearing loss; Sudden deafness; Acoustic trauma; Noise trauma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hearing loss

  Days 3, 30, 90

Study Arms (3)

2

EXPERIMENTAL

AM-111 low dose

Drug: AM-111

1

PLACEBO COMPARATOR

Drug: placebo

3

EXPERIMENTAL

AM-111 high dose

Drug: AM-111

Interventions

AM-111 DRUG

single intratympanic injection

2; 3

placebo DRUG

single intratympanic injection

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Auris Medical AG: lead

Study Sites (1)

LMU Munich Klinikum Grosshadern

Munich, 81366, Germany

Location

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Sudden; Hearing Loss, Noise-Induced

Interventions

D-JNKI-1

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hearing Loss, Sensorineural

Study Officials

• Markus M Suckfüll, MD

  LMU Munich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2008
• First Posted: December 4, 2008
• Study Start: December 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 26, 2014

Record last verified: 2014-06

Locations

DE (1)