Hearing LossPhase 3HEALOSNCT02561091
AM-111 in the Treatment of Acute Inner Ear Hearing Loss
A Phase 3 study testing AM-111 0.4 mg/ml and AM-111 0.8 mg/ml in people with Hearing Loss, run by Auris Medical AG at 1 site in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- AM-111 0.4 mg/ml and AM-111 0.8 mg/ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteBulgaria
- Study dates
- Nov 2015to Sep 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Please check link to study webpage below for more study sites
Sofia
About this study
Official title: Efficacy and Safety of AM-111 in the Treatment of Acute Inner Ear Hearing Loss
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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- Placebo, AM-111 0.4 mg/ml, AM-111 0.8 mg/ml
- Keywords
- Deafness, Hearing Loss, Sensorineural, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases, Sensation Disorders, Signs and Symptoms, Hearing and Speech impairment, Hearing Loss, Unilateral
- Medical subject headings
- Hearing Loss, Deafness, Hearing Loss, Sensorineural, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases, Sensation Disorders, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
AM-111 0.4 mg/mlDrug
AM-111 0.8 mg/mlDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo gel for intratympanic use Receives: Other: Placebo |
| AM-111 0.4 mg/ml | Experimental | AM-111 gel for intratympanic use (0.4 mg/ml AM-111) Receives: Drug: AM-111 0.4 mg/ml |
| AM-111 0.8 mg/ml | Experimental | AM-111 gel for intratympanic use (0.8 mg/ml AM-111) Receives: Drug: AM-111 0.8 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auris Medical AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561091
- Sponsor's protocol ID
- AM-111-CL-13-01
- Acronym
- HEALOS
- Status last verified
- Sep 2023
- First submitted
- 23 Sep 2015
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of AM-111 in the Treatment of Acute Inner Ear Hearing Loss
- ClinicalTrials.gov ID
- NCT02561091
- Acronym / sponsor ID
- HEALOS / AM-111-CL-13-01
- Conditions
- Hearing Loss
- Keywords
- Deafness, Hearing Loss, Sensorineural, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases, Sensation Disorders, Signs and Symptoms, Hearing and Speech impairment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Auris Medical AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo gel for intratympanic use |
| AM-111 0.4 mg/ml | Experimental | Drug: AM-111 0.4 mg/mlAM-111 gel for intratympanic use (0.4 mg/ml AM-111) |
| AM-111 0.8 mg/ml | Experimental | Drug: AM-111 0.8 mg/mlAM-111 gel for intratympanic use (0.8 mg/ml AM-111) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo | Other | Placebo |
| AM-111 0.4 mg/ml | Drug | AM-111 0.4 mg/ml |
| AM-111 0.8 mg/ml | Drug | AM-111 0.8 mg/ml |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Link to Result entry in clinicaltrialsregister.euLink provided by the sponsor.
- Link to peer-reviewed publication of studyLink provided by the sponsor.
Related trials for Hearing Loss
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
Hearing Loss
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AM-111 0.4 mg/ml and AM-111 0.8 mg/ml in people with Hearing Loss, run by Auris Medical AG at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pure tone average (PTA; average of the hearing threshold of three contiguous most affected hearing frequencies in dB) (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.