TinnitusPhase 3AMPACT2NCT02040207
AM-101 in the Treatment of Post-Acute Tinnitus 2
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 local tolerance of repeated treatment with AM-101. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- AM-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 487 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Dec 2016
- 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 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of TACTT3 study;
- Negative pregnancy test (woman of childbearing potential);
- Willing and able to attend the study visits.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Adverse event leading to treatment discontinuation in TACTT3;
- Meniere's Disease, endolymphatic hydrops, acoustic neuroma, severe or fluctuating hearing loss, otitis media, otitis externa, abnormality of tympanic membrane;
- Ongoing drug-based therapy for otitis media or otitis externa;
- Drug-based therapy known as potentially tinnitus-inducing;
- Other treatment of tinnitus;
- Drug abuse or alcoholism;
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- Subjects with psychiatric diseases requiring drug treatment;
- Use of antidepressant or anti-anxiety medication;
- Any clinically relevant disorder or abnormality in physical examination;
- 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.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 2 (AMPACT2) - an Open-Label Extension to the TACTT3 Study
The purpose of this research study is to test the safety and local tolerance of repeated treatment with AM-101.
Read the detailed description
This open-label extension study is assessing the safety and local tolerance of repeated treatment with AM-101 in subjects previously treated in the scope of the TACTT3 study.
- Conditions
- Tinnitus
- Being tested
- AM-101
- 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
| Study group | Role | What they receive |
|---|---|---|
| AM-101 injection | Experimental | AM-101 gel for intratympanic injection Receives: Drug: AM-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing threshold
Occurrence of deterioration in hearing threshold in the treated ear(s)
Measured: Up to Day 203
Secondary outcomes (2)
Hearing threshold
Difference and occurence of deterioration of hearing threshold in the treated ear(s)
Measured: Up to Day 252
Adverse events and serious adverse events
Occurrence and severity of adverse events and serious adverse events
Measured: Up to Day 252
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 startJun 2014
- Primary completionDec 2016
- Study completionDec 2016
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 487 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
- NCT02040207
- Sponsor's protocol ID
- AM-101-CL-12-04
- Acronym
- AMPACT2
- 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
- AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 2 (AMPACT2) - an Open-Label Extension to the TACTT3 Study
- ClinicalTrials.gov ID
- NCT02040207
- Acronym / sponsor ID
- AMPACT2 / AM-101-CL-12-04
- Conditions
- Tinnitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- Auris Medical AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (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 local tolerance of repeated treatment with AM-101.
Detailed description
This open-label extension study is assessing the safety and local tolerance of repeated treatment with AM-101 in subjects previously treated in the scope of the TACTT3 study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AM-101 injection | Experimental | Drug: AM-101AM-101 gel for intratympanic injection |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Completion of TACTT3 study;
- Negative pregnancy test (woman of childbearing potential);
- Willing and able to attend the study visits.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (12 listed)
- Adverse event leading to treatment discontinuation in TACTT3;
- Meniere's Disease, endolymphatic hydrops, acoustic neuroma, severe or fluctuating hearing loss, otitis media, otitis externa, abnormality of tympanic membrane;
- Ongoing drug-based therapy for otitis media or otitis externa;
- Drug-based therapy known as potentially tinnitus-inducing;
- Other treatment of tinnitus;
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 |
Primary outcome
Hearing threshold
Time frame: Up to Day 203
Occurrence of deterioration in hearing threshold in the treated ear(s)
2 secondary outcomes
Hearing threshold
Time frame: Up to Day 252
Adverse events and serious adverse events
Time frame: Up to Day 252
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 4 inclusion and 12 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. 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?
Hearing threshold (time frame: Up to Day 203). 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.