TinnitusPhase 2TACTT1NCT01270282
Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus
A Phase 2 study testing AM-101 0.81 mg/mL in people with Tinnitus, run by Auris Medical, Inc. at 16 sites in 4 countries.
Trial summary
The purpose of the study is to evaluate the therapeutic benefit and safety of intratympanic AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- AM-101 0.81 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 16 sitesin 4 countries
- Study dates
- Feb 2011to May 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tinnitus following acute acoustic trauma, acute otitis media, middle ear surgery or inner ear barotrauma; with onset less than three months ago.
Who cannot join
- Tinnitus that is not completely maskable
- Fluctuating tinnitus
- Intermittent tinnitus
- Meniere's Disease
- Ongoing acute or chronic otitis media or otitis externa.
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
United States5 sites
Summit Medical Group
Berkeley Heights, New Jersey, 07922
University of Florida College of Medicine
Gainsville, Florida, 32610-0264
University of Kansas Medical Center
Kansas City, Kansas, 66160
Advanced ENT & Allergy
Louisville, Kentucky, 40207
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103
Germany5 sites
HNO Praxis im Schlosscarree
Braunschweig, 38100
HNO Praxis
Cologne, 51061
Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
Frankfurt am Main, 60590
HNO Gemeinschaftspraxis
Heidelberg, 69126
Bundeswehrkrankenhaus Ulm
Ulm, 89081
Belgium3 sites
UZ Antwerp, Department of ENT
Edegem, 2650
Gent University Hospital, Department of ENT
Ghent, 9000
Virga Jesseziekenhuis Hasselt
Hasselt, 3500
Poland3 sites
NZOZ Laryngologii Wojewodzki Szpital Specjalistyczny
Rzeszów, 35-055
NZOZ Centrum Medyczne LiMED
Tarnowskie Góry, 42-600
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Warsaw, 02-097
About this study
The purpose of the study is to evaluate the therapeutic benefit and safety of intratympanic AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus.
- Conditions
- Tinnitus
- Being tested
- AM-101 0.81 mg/mL, 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-101 0.81 mg/mLDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| AM-101 0.81 mg/mL | Experimental | Gel for injection; single or triple injection Receives: Drug: AM-101 0.81 mg/mL |
| Placebo | Placebo comparator | Gel for injection; single or triple injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection
Measured: 90 or 104 days
Secondary outcomes (3)
Standard audiological evaluations
Pure tone audiometry, tympanometry, otoscopy, tinnitus loudness match
Measured: 90 or 104 days
Questionnaires evaluating the impact of tinnitus
Patient global impression of change scale, subjective tinnitus annoyance and loudness, tinnitus handicap questionaire
Measured: 90 or 104 days
Pharmacokinetic measures
Measured: 3 or 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2013
- Study completionMay 2013
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auris Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270282
- Sponsor's protocol ID
- AM-101-CL-10-02
- Other IDs
- AM-101-CL-10-02
- Acronym
- TACTT1
- Status last verified
- Jan 2015
- First submitted
- 30 Dec 2010
- Last updated
- 26 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus
- ClinicalTrials.gov ID
- NCT01270282
- Acronym / sponsor ID
- TACTT1 / AM-101-CL-10-02
- Conditions
- Tinnitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Auris Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Jan 2011 (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 evaluate the therapeutic benefit and safety of intratympanic AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus.
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 0.81 mg/mL | Experimental | Drug: AM-101 0.81 mg/mLGel for injection; single or triple injection |
| Placebo | Placebo comparator | Drug: PlaceboGel for injection; single or triple injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Tinnitus following acute acoustic trauma, acute otitis media, middle ear surgery or inner ear barotrauma; with onset less than three months ago.
Key exclusion criteria (5 listed)
- Tinnitus that is not completely maskable
- Fluctuating tinnitus
- Intermittent tinnitus
- Meniere's Disease
- Ongoing acute or chronic otitis media or otitis externa.
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-101 0.81 mg/mL | Drug | AM-101 0.81 mg/mL |
| Placebo | Drug | Placebo |
Primary outcome
The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection
Time frame: 90 or 104 days
3 secondary outcomes
Standard audiological evaluations
Time frame: 90 or 104 days
Questionnaires evaluating the impact of tinnitus
Time frame: 90 or 104 days
Pharmacokinetic measures
Time frame: 3 or 14 days
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 Jan 2015.
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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.
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AM-101 0.81 mg/mL in people with Tinnitus, run by Auris Medical, Inc. at 16 sites in 4 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 1 inclusion and 5 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 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Germany, Belgium, Poland. 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?
The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection (time frame: 90 or 104 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 Jan 2015.