Hearing Loss, Idiopathic Sudden SensorineuralPhase 3ASSENTNCT02809118
Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
A Phase 3 study testing AM-111 0.4 mg/ml and AM-111 0.8 mg/ml in people with Hearing Loss, Idiopathic Sudden Sensorineural, run by Auris Medical, Inc. at 51 sites in 3 countries.
Trial summary
The primary objective of the trial is the confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Idiopathic Sudden Sensorineural
- 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
- 56 participants
- Where
- 51 sitesin 3 countries
- Study dates
- Jun 2016to Feb 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral idiopathic sudden sensorineural hearing loss (ISSNHL) with onset within 72 hours prior to study treatment;
- Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across those 3 contiguous air conduction audiometric pure tone frequencies that show the highest mean hearing loss compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a pre-existing audiogram for the affected ear not older than 2 years prior to the ISSNHL incident (defined as "pure tone average", PTA);
- Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air conduction thresholds at the pure tone average frequencies compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a preexisting audiogram for the affected ear not older than 2 years prior to the ISSNHL incident;
- Age ≥ 18 years on the day of screening;
Who cannot join
- Bilateral ISSNHL;
- Acute hearing loss from noise trauma, barotrauma or head trauma;
- Air-bone gap greater than 20 dB at the average of 3 contiguous test frequencies below 4 kHz, when the air-bone gap is measurable;
- History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière's disease in either ear;
- History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
- Current evidence or history of acoustic neuroma or other retrocochlear damage in the affected ear;
Show all 11Show fewer
- 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;
Trial locations and contacts
51 sites in 3 countries.
51 sites in 3 countries
United States38 sites
Study site
Aurora, Colorado, 80045
Study site
Birmingham, Alabama, 35294-0012
Study site
Boca Raton, Florida, 33487
Study site
Boynton Beach, Florida, 33426-6398
Study site
Celebration, Florida, 34747
Study site
Charleston, South Carolina, 29425
Study site
Charlotte, New York, 28210
Study site
Chicago, Illinois, 60657
Study site
Columbia, Missouri, 65212
Study site
Des Moines, Iowa, 50312
Study site
Escondido, California, 92025
Study site
Fort Sam Houston, Texas, 78234
Study site
Fresno, California, 93720
Study site
Havertown, Pennsylvania, 19083
Study site
Kansas City, Kansas, 66160
Study site
La Jolla, California, 92037-1214
Study site
Lebanon, New Hampshire, 03756
Study site
Louisville, Kentucky, 40207
Study site
Lugoff, South Carolina, 29078
Study site
Matthews, North Carolina, 28105
Study site
Miami, Florida, 33133
Study site
Miami, Florida, 33176
Study site
Nashville, Tennessee, 37232-8605
Study site
New Haven, Connecticut, 06519
Study site
New Hyde Park, New York, 11042-1121
Study site
New Windsor, New York, 12553
Study site
New York, New York, 10032
Study site
Norfolk, Virginia, 23507
Study site
Novi, Michigan, 48374
Study site
Orangeburg, South Carolina, 29118
Study site
Philadelphia, Pennsylvania, 19107
Study site
Port Saint Lucie, Florida, 34952
Study site
Rochester, New York, 14618
Study site
Salt Lake City, Utah, 84102
Study site
St. George, Utah, 84790
Study site
Tacoma, Washington, 98431-1100
Study site
White Plains, New York, 10601-4413
Study site
Winston-Salem, North Carolina, 27103-1522
South Korea10 sites
Study site
Gwangju
Study site
Incheon, Jung-Gu
Study site
Pusan
Study site
Seongnam-si, Gyeonggi-do
Study site
Seoul, 3722
Study site
Seoul, 61469
Study site
Seoul, 6591
Study site
Seoul, 8308
Study site
Seoul
Study site
Suwon, Gyeonggi-do
Canada3 sites
Study site
Kelowna, British Columbia
Study site
Markham, Ontario
Study site
Penticton, British Columbia
About this study
The primary objective of the trial is the confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).
Read the detailed description
This is a Phase III, randomized, double-blind, placebo-controlled, parallel group, multi-center, efficacy and safety trial of AM-111 in the treatment of subjects suffering from severe to profound idiopathic sudden sensorineural hearing loss.
The active pharmaceutical ingredient of AM-111 is a 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.
The study consists of one treatment visit and a follow-up period until day 91.
Study participants will receive, after topical anesthesia of the tympanic membrane, AM-111 0.4 mg/mL or 0.8 mg/mL or placebo, administered into the affected ear. Following the administration, subjects will rest in a supine or reclined position for 30 minutes. Study participants will have the option for a course of oral corticosteroids.
- Being tested
- AM-111 0.4 mg/ml, AM-111 0.8 mg/ml, Placebo
- Keywords
- Deafness, Hearing Loss, Hearing Loss, Sensorineural, Ear Diseases, Hearing Disorders, Nervous System Diseases, Neurologic Manifestations, 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, Nervous System Diseases, Neurologic Manifestations, Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AM-111 0.4 mg/mlDrug
Also called Brimapitide
AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
AM-111 0.8 mg/mlDrug
Also called Brimapitide
AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
PlaceboOther
Placebo gel is administered with a single dose into the affected ear after topical anesthesia
| 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)
Measurement of the recovery of hearing between Day 0 (before treatment) and Day 91, i.e. change in pure tone audiometry between Day 0 and Day 91. The study was prematurely terminated. It was pre-specified not to complete analyses due to premature termination. Not all data planned were collected. No meaningful efficacy analysis could be performed on the data.
Measured: Day 0 and Day 91: The study was prematurely terminated.
Secondary outcomes (1)
Word Recognition Score (WRS) - Main Secondary
Change in WRS from Day 0 to Day 91. The WRS was determined with country-/language-specific word lists. At least 20 mono- or disyllabic words were presented in random order. After each word was presented to the subject, the subject was asked to repeat it, and to guess it, if he/she was not sure of the word. The study was prematurely terminated. It was pre-specified not to complete analyses due to premature termination. Not all data planned were collected. No meaningful efficacy analysis could be performed on the data.
Measured: Day 0 and Day 91: The study was prematurely terminated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Why it stopped: Availability of relevant new efficacy data from another study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, Idiopathic Sudden SensorineuralStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auris Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Meier, Study director, Auris Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809118
- Sponsor's protocol ID
- AM-111-CL-15-01
- Acronym
- ASSENT
- Status last verified
- Jun 2020
- First submitted
- 20 Jun 2016
- Last updated
- 7 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
- ClinicalTrials.gov ID
- NCT02809118
- Acronym / sponsor ID
- ASSENT / AM-111-CL-15-01
- Keywords
- Deafness, Hearing Loss, Hearing Loss, Sensorineural, Ear Diseases, Hearing Disorders, Nervous System Diseases, Neurologic Manifestations, Otorhinolaryngologic Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Availability of relevant new efficacy data from another study
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Auris Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Posted 7 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the trial is the confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).
Detailed description
This is a Phase III, randomized, double-blind, placebo-controlled, parallel group, multi-center, efficacy and safety trial of AM-111 in the treatment of subjects suffering from severe to profound idiopathic sudden sensorineural hearing loss.
The active pharmaceutical ingredient of AM-111 is a 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.
The study consists of one treatment visit and a follow-up period until day 91.
Study participants will receive, after topical anesthesia of the tympanic membrane, AM-111 0.4 mg/mL or 0.8 mg/mL or placebo, administered into the affected ear. Following the administration, subjects will rest in a supine or reclined position for 30 minutes. Study participants will have the option for a course of oral corticosteroids.
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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral idiopathic sudden sensorineural hearing loss (ISSNHL) with onset within 72 hours prior to study treatment;
- Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across those 3 contiguous air conduction audiometric pure tone frequencies that show the highest mean hearing loss compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a pre-existing audiogram for the affected ear not older than 2 years prior to the ISSNHL incident (defined as "pure tone average", PTA);
- Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air conduction thresholds at the pure tone average frequencies compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a preexisting audiogram for the affected ear not older than 2 years prior to the ISSNHL incident;
- Age ≥ 18 years on the day of screening;
Key exclusion criteria (11 listed)
- Bilateral ISSNHL;
- Acute hearing loss from noise trauma, barotrauma or head trauma;
- Air-bone gap greater than 20 dB at the average of 3 contiguous test frequencies below 4 kHz, when the air-bone gap is measurable;
- History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière's disease in either ear;
- History of chronic inflammatory or suppurative ear disease or cholesteatoma 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 |
|---|---|---|
| AM-111 0.4 mg/mlAlso: BrimapitideAM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia | Drug | AM-111 0.4 mg/ml |
| AM-111 0.8 mg/mlAlso: BrimapitideAM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia | Drug | AM-111 0.8 mg/ml |
| PlaceboPlacebo gel is administered with a single dose into the affected ear after topical anesthesia | Other | Placebo |
Primary outcome
Pure Tone Average (PTA)
Time frame: Day 0 and Day 91: The study was prematurely terminated.
Measurement of the recovery of hearing between Day 0 (before treatment) and Day 91, i.e. change in pure tone audiometry between Day 0 and Day 91. The study was prematurely terminated. It was pre-specified not to complete analyses due to premature termination. Not all data planned were collected. No meaningful efficacy analysis could be performed on the data.
1 secondary outcome
Word Recognition Score (WRS) - Main Secondary
Time frame: Day 0 and Day 91: The study was prematurely terminated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Thomas Meier study director
Auris Medical, Inc.
51 sites in 3 countries: 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, Idiopathic Sudden Sensorineural, run by Auris Medical, Inc. at 51 sites in 3 countries.
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 4 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: stopped early, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, South Korea, Canada. 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?
Yes. Results are posted in the registry (first posted 7 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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) (time frame: Day 0 and Day 91: The study was prematurely terminated.). 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 7 Aug 2020.