AM-111 in the Treatment of Acute Inner Ear Hearing Loss (HEALOS)
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ClinicalTrials.gov Identifier: NCT02561091 |
Recruitment Status :
Completed
First Posted : September 25, 2015
Last Update Posted : October 16, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hearing Loss | Other: Placebo Drug: AM-111 0.4 mg/ml Drug: AM-111 0.8 mg/ml | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 256 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of AM-111 in the Treatment of Acute Inner Ear Hearing Loss |
Study Start Date : | November 2015 |
Actual Primary Completion Date : | September 2017 |
Actual Study Completion Date : | September 2017 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo gel for intratympanic use
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Other: Placebo |
Experimental: AM-111 0.4 mg/ml
AM-111 gel for intratympanic use (0.4 mg/ml AM-111)
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Drug: AM-111 0.4 mg/ml |
Experimental: AM-111 0.8 mg/ml
AM-111 gel for intratympanic use (0.8 mg/ml AM-111)
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Drug: AM-111 0.8 mg/ml |
- Pure tone average (PTA; average of the hearing threshold of three contiguous most affected hearing frequencies in dB) [ Time Frame: Day 28 ]Assessment with pure tone audiometry/ Measurement at 8 frequencies/ Final outcome is the absolute improvement in PTA from D0 to D28

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Unilateral ISSNHL with onset within 72 hours prior to study treatment;
- Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across the 3 most affected contiguous air conduction audiometric pure tone frequencies ("pure tone average", PTA);*
- Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air conducted PTA frequencies compared with the unaffected contralateral ear or reference values from a pre-existing audiogram or ISO 7029;2000 norm values in case of asymmetric hearing prior to the ISSNHL incident;
- Age ≥ 18 and ≤ 65 years on the day of screening;
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Bilateral ISSNHL;
- Acute hearing loss from noise trauma, barotrauma or head trauma;
- History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière's disease in the affected ear;
- History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
- History of acoustic neuroma or other retrocochlear damage in the affected ear;
- History of otosclerosis in the affected ear;
- Suspected perilymph fistula or membrane rupture in the affected ear;
- Congenital hearing loss;
- History of ISSNHL in the past 2 years;
- Otitis media or otitis externa that is ongoing or ended within 7 days prior to study treatment;
Other protocol-defined exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561091
Bulgaria | |
Please check link to study webpage below for more study sites | |
Sofia, Bulgaria |
Responsible Party: | Auris Medical AG |
ClinicalTrials.gov Identifier: | NCT02561091 |
Other Study ID Numbers: |
AM-111-CL-13-01 |
First Posted: | September 25, 2015 Key Record Dates |
Last Update Posted: | October 16, 2017 |
Last Verified: | August 2017 |
Deafness Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Otorhinolaryngologic Diseases |
Sensation Disorders Signs and Symptoms Hearing and Speech impairment Hearing Loss, Unilateral |
Hearing Loss Deafness Hearing Loss, Sensorineural Hearing Disorders Ear Diseases |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |