Tinnitus
Conditions
Brief 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.
Interventions
DRUGAM-101 0.81 mg/mL
DRUGPlacebo
Sponsors
Auris Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Tinnitus following acute acoustic trauma, acute otitis media, middle ear surgery or inner ear barotrauma; with onset less than three months ago.
Exclusion criteria
* Tinnitus that is not completely maskable * Fluctuating tinnitus * Intermittent tinnitus * Meniere's Disease * Ongoing acute or chronic otitis media or otitis externa.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection | 90 or 104 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standard audiological evaluations | 90 or 104 days | Pure tone audiometry, tympanometry, otoscopy, tinnitus loudness match |
| Questionnaires evaluating the impact of tinnitus | 90 or 104 days | Patient global impression of change scale, subjective tinnitus annoyance and loudness, tinnitus handicap questionaire |
| Pharmacokinetic measures | 3 or 14 days | — |
Countries
Belgium, Germany, Poland, United States
Outcome results
None listed