TinnitusPhase 3TACTT3NCT02040194
AM-101 in the Treatment of Acute Tinnitus 3
A Phase 3 study testing AM-101 in people with Tinnitus, run by Auris Medical AG at 1 site in Germany.
Trial summary
The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an injury to the inner ear or due to middle ear inflammation (otitis media). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- AM-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 893 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to 28 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent subjective peripheral tinnitus (unilateral or bilateral) following traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma, tympanic membrane trauma) or otitis media with onset no longer than 3 months (Stratum A) or between >3 months and 6 months (Stratum B) prior to randomization, as documented by medical report or by documented medical history. Upon implementation of protocol amendment 6, subjects with tinnitus following traumatic cochlear injury will only be eligible if they are affected only unilaterally.
- Age ≥ 18 years and ≤ 75 years;
- Negative pregnancy test (woman of childbearing potential);
- Willing and able to use adequate hearing protection, respectively to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured;
- Willing and able to protect ear canal and middle ear from water exposure as long as tympanic membrane is not fully closed.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Fluctuating tinnitus;
- Intermittent tinnitus;
- Tinnitus resulting from traumatic head or neck injury;
- Presence of chronic tinnitus;
- Meniere's Disease, history of endolymphatic hydrops, or history of fluctuating hearing loss;
- History of repeated idiopathic sudden sensorineural hearing loss or history of acoustic neuroma;
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- Ongoing acute or chronic otitis media or otitis externa;
- Other treatment of tinnitus for the study duration;
- 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 are planning to become pregnant during the study;
- Women of childbearing potential who are unwilling or unable to practice contraception, such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with a partner who has been vasectomised for at least three months;
- Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to randomization.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Please check the study webpage below for a study site list
Munich
About this study
Official title: Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 3
The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with tinnitus can take part in the study, if their tinnitus started within the last 3 months or within the last >3 to 6 months.
Read the detailed description
This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated intratympanic AM-101 injections in the treatment of acute peripheral tinnitus (up to 3 months (Stratum A), or between >3 and 6 months (Stratum B) from onset).
- Conditions
- Tinnitus
- Being tested
- AM-101, Placebo
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AM-101Drug
AM-101 gel for intratympanic injection
PlaceboDrug
Placebo gel for intratympanic injection
| Study group | Role | What they receive |
|---|---|---|
| AM-101 injection | Experimental | AM-101 Receives: Drug: AM-101 |
| Placebo injection | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy endpoint - alternate primary efficacy endpoints: Tinnitus Functional Index (TFI)
Improvement in TFI total score
Measured: Baseline to Day 84
Efficacy endpoint - alternate primary efficacy endpoints: Patient-reported Tinnitus loudness on a Numerical Rating Scale (TLQ NRS loudest)
Improvement in TLQ NRS loudest
Measured: Baseline to Day 84
Safety endpoint: Hearing threshold
Occurrence of deterioration in hearing threshold >= 15 decibel (dB) at the average of two contiguous test frequencies (air conduction) in the treated ear(s)
Measured: Baseline to Day 35
Secondary outcomes (8)
Efficacy endpoint - TFI
Improvement in TFI total score
Measured: Baseline to Day 10 and Day 35
Efficacy endpoint - TLQ NRS loudest
Improvement in patient-reported tinnitus loudness
Measured: Baseline to Day 10 and Day 35
Efficacy endpoint - patient-reported tinnitus annoyance (TAQ NRS worst)
Improvement in TAQ NRS worst
Measured: Baseline to Day10, Day 35 and Day 84
Efficacy endpoint - TFI sleep score
Improvement in TFI sleep score. The subscale "sleep" will be evaluated only for subjects with a TFI Sleep score greater than 0 at baseline.
Measured: Baseline to Day10, Day 35 and Day 84
Efficacy endpoint - Patient global impression of change in tinnitus severity (PGIC Tinnitus)
Patient global impression of change in tinnitus severity
Measured: at Day10, Day 35 and Day 84
Safety endpoint - Hearing threshold
Occurrence of deterioration in hearing threshold >= 15 dB at the average of two contiguous test frequencies in the treated ear(s)
Measured: Baseline to Day 1, Day 2, Day 10 and Day 84
Safety endpoint - Hearing threshold
Difference in occurrence of deterioration in hearing threshold >= 15 dB at the average of two contiguous test frequencies between the treated and untreated contralateral ear (subjects with unilaterally treated tinnitus only)
Measured: Baseline to Day 1, Day 2, Day 10 and Day 84
Safety endpoint - AEs and SAEs
Occurence and severity of adverse events (AEs) and serious adverse Events (SAEs), differentiated by relatedness, and by treatment-emergence and procedure-emergence
Measured: Up to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJan 2014
- Primary completion28 Dec 2017
- Study completion28 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies 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
- 893 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
- NCT02040194
- Sponsor's protocol ID
- AM-101-CL-12-02
- Acronym
- TACTT3
- Status last verified
- Sep 2023
- First submitted
- 14 Jan 2014
- 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-101 in the Treatment of Acute Peripheral Tinnitus 3
- ClinicalTrials.gov ID
- NCT02040194
- Acronym / sponsor ID
- TACTT3 / AM-101-CL-12-02
- Conditions
- Tinnitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 893 participants (actual)
- Lead sponsor
- Auris Medical AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- 28 Dec 2017 (actual)
- Study completion
- 28 Dec 2017 (actual)
- First posted
- 20 Jan 2014 (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 safety and effectiveness of the study drug, AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with tinnitus can take part in the study, if their tinnitus started within the last 3 months or within the last >3 to 6 months.
Detailed description
This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated intratympanic AM-101 injections in the treatment of acute peripheral tinnitus (up to 3 months (Stratum A), or between >3 and 6 months (Stratum B) from onset).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AM-101 injection | Experimental | Drug: AM-101AM-101 |
| Placebo injection | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Persistent subjective peripheral tinnitus (unilateral or bilateral) following traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma, tympanic membrane trauma) or otitis media with onset no longer than 3 months (Stratum A) or between >3 months and 6 months (Stratum B) prior to randomization, as documented by medical report or by documented medical history. Upon implementation of protocol amendment 6, subjects with tinnitus following traumatic cochlear injury will only be eligible if they are affected only unilaterally.
- Age ≥ 18 years and ≤ 75 years;
- Negative pregnancy test (woman of childbearing potential);
- Willing and able to use adequate hearing protection, respectively to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured;
- Willing and able to protect ear canal and middle ear from water exposure as long as tympanic membrane is not fully closed.
Key exclusion criteria (13 listed)
- Fluctuating tinnitus;
- Intermittent tinnitus;
- Tinnitus resulting from traumatic head or neck injury;
- Presence of chronic tinnitus;
- Meniere's Disease, history of endolymphatic hydrops, or history of 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-101AM-101 gel for intratympanic injection | Drug | AM-101 injection |
| PlaceboPlacebo gel for intratympanic injection | Drug | Placebo injection |
Primary outcome
Efficacy endpoint - alternate primary efficacy endpoints: Tinnitus Functional Index (TFI)
Time frame: Baseline to Day 84
Improvement in TFI total score
Efficacy endpoint - alternate primary efficacy endpoints: Patient-reported Tinnitus loudness on a Numerical Rating Scale (TLQ NRS loudest)
Time frame: Baseline to Day 84
Improvement in TLQ NRS loudest
Safety endpoint: Hearing threshold
Time frame: Baseline to Day 35
Occurrence of deterioration in hearing threshold >= 15 decibel (dB) at the average of two contiguous test frequencies (air conduction) in the treated ear(s)
8 secondary outcomes
Efficacy endpoint - TFI
Time frame: Baseline to Day 10 and Day 35
Efficacy endpoint - TLQ NRS loudest
Time frame: Baseline to Day 10 and Day 35
Efficacy endpoint - patient-reported tinnitus annoyance (TAQ NRS worst)
Time frame: Baseline to Day10, Day 35 and Day 84
Efficacy endpoint - TFI sleep score
Time frame: Baseline to Day10, Day 35 and Day 84
Efficacy endpoint - Patient global impression of change in tinnitus severity (PGIC Tinnitus)
Time frame: at Day10, Day 35 and Day 84
Safety endpoint - Hearing threshold
Time frame: Baseline to Day 1, Day 2, Day 10 and Day 84
Safety endpoint - Hearing threshold
Time frame: Baseline to Day 1, Day 2, Day 10 and Day 84
Safety endpoint - AEs and SAEs
Time frame: Up to Day 84
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.
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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.
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-101 in people with Tinnitus, 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 13 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 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 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?
Efficacy endpoint - alternate primary efficacy endpoints: Tinnitus Functional Index (TFI) (time frame: Baseline to Day 84). The study lists 3 primary outcomes in all. 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.