Hearing LossPhase 2NCT00802425
Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss
A Phase 2 study testing AM-111 in people with Hearing Loss, run by Auris Medical AG at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- AM-111
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2008to Oct 2012
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics, quinine etc.) in the past 6 months prior to study inclusion
- 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
- Any current anticoagulant therapy (e.g. Aspirin, Marcumar, etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Dose-Escalation Phase II Study
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
- Being tested
- AM-111, placebo
- Keywords
- Sudden hearing loss, Sudden deafness, Acoustic trauma, Noise trauma
- Medical subject headings
- Hearing Loss, Hearing Loss, Sudden, Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AM-111Drug
single intratympanic injection
placeboDrug
single intratympanic injection
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | AM-111 low dose Receives: Drug: AM-111 |
| 1 | Placebo comparator | Not described Receives: Drug: placebo |
| 3 | Experimental | AM-111 high dose Receives: Drug: AM-111 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (1)
Hearing loss
Average change in hearing loss in dB between the baseline and D3, D30, and D90 for the three contiguous frequencies with the worst hearing loss, identified at study entry
Measured: Days 3, 30, 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJul 2012
- Study completionOct 2012
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auris Medical AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Markus M Suckfüll, MD, Study director, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802425
- Sponsor's protocol ID
- AM-111-CL-08-01
- Other IDs
- EudraCT number 2008-000132-40
- Status last verified
- Jun 2014
- First submitted
- 3 Dec 2008
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of AM-111 in Patients With Acute Sensorineural Hearing Loss: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Dose-Escalation Phase II Study
- ClinicalTrials.gov ID
- NCT00802425
- Acronym / sponsor ID
- AM-111-CL-08-01
- Conditions
- Hearing Loss
- Keywords
- Sudden hearing loss, Sudden deafness, Acoustic trauma, Noise trauma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Auris Medical AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Dec 2008 (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 the study is to determine whether AM-111 is effective in the treatment of acute inner ear hearing loss (acute sensorineural hearing loss, ASNHL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: AM-111AM-111 low dose |
| 1 | Placebo comparator | Drug: placebo |
| 3 | Experimental | Drug: AM-111AM-111 high dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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-111single intratympanic injection | Drug | 2, 3 |
| placebosingle intratympanic injection | Drug | 1 |
Primary outcome
Hearing loss
Time frame: 7 days
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
1 secondary outcome
Hearing loss
Time frame: Days 3, 30, 90
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 26 Jun 2014.
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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.
Markus M Suckfüll, MD study director
LMU Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AM-111 in people with Hearing Loss, run by Auris Medical AG at 1 site in Germany.
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 6 inclusion and 17 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 26 Jun 2014. 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Hearing loss (time frame: 7 days). 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 26 Jun 2014.