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AM-111 in the Treatment of Acute Inner Ear Hearing Loss (HEALOS)

Primary Purpose

Hearing Loss

Status
Completed
Phase
Phase 3
Locations
Bulgaria
Study Type
Interventional
Intervention
Placebo
AM-111 0.4 mg/ml
AM-111 0.8 mg/ml
Sponsored by
Auris Medical AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Deafness, Hearing Loss, Sensorineural, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases, Sensation Disorders, Signs and Symptoms, Hearing and Speech impairment, Hearing Loss, Unilateral

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Unilateral ISSNHL with onset within 72 hours prior to study treatment;
  2. 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);*
  3. 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;
  4. Age ≥ 18 and ≤ 65 years on the day of screening;

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  1. Bilateral ISSNHL;
  2. Acute hearing loss from noise trauma, barotrauma or head trauma;
  3. History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière's disease in the affected ear;
  4. History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
  5. History of acoustic neuroma or other retrocochlear damage in the affected ear;
  6. History of otosclerosis in the affected ear;
  7. Suspected perilymph fistula or membrane rupture in the affected ear;
  8. Congenital hearing loss;
  9. History of ISSNHL in the past 2 years;
  10. Otitis media or otitis externa that is ongoing or ended within 7 days prior to study treatment;

Other protocol-defined exclusion criteria may apply.

Sites / Locations

  • Please check link to study webpage below for more study sites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

AM-111 0.4 mg/ml

AM-111 0.8 mg/ml

Arm Description

Placebo gel for intratympanic use

AM-111 gel for intratympanic use (0.4 mg/ml AM-111)

AM-111 gel for intratympanic use (0.8 mg/ml AM-111)

Outcomes

Primary Outcome Measures

Pure tone average (PTA; average of the hearing threshold of three contiguous most affected hearing frequencies in dB)
Assessment with pure tone audiometry/ Measurement at 8 frequencies/ Final outcome is the absolute improvement in PTA from D0 to D28

Secondary Outcome Measures

Full Information

First Posted
September 23, 2015
Last Updated
September 13, 2023
Sponsor
Auris Medical AG
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1. Study Identification

Unique Protocol Identification Number
NCT02561091
Brief Title
AM-111 in the Treatment of Acute Inner Ear Hearing Loss
Acronym
HEALOS
Official Title
Efficacy and Safety of AM-111 in the Treatment of Acute Inner Ear Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Auris Medical AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to test the effectiveness and safety of the study drug, AM-111. AM-111 is tested for the treatment of sudden sensorineural hearing loss where the cause is unknown.
Detailed Description
This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of intratympanic AM-111 injections in the treatment of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL). The active pharmaceutical ingredient of AM-111 is the JNK inhibitor (D-JNKI-1), a synthetic peptide consisting of 31 D-amino acids, which acts as a c-Jun N-terminal kinase (JNK) ligand.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Deafness, Hearing Loss, Sensorineural, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases, Sensation Disorders, Signs and Symptoms, Hearing and Speech impairment, Hearing Loss, Unilateral

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Please check link to study webpage below for more study sites
City
Sofia
Country
Bulgaria

12. IPD Sharing Statement

Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-002077-21/results
Description
Link to Result entry in clinicaltrialsregister.eu
URL
https://pubmed.ncbi.nlm.nih.gov/31083077/
Description
Link to peer-reviewed publication of study

Learn more about this trial

AM-111 in the Treatment of Acute Inner Ear Hearing Loss

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