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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
82
University of Florida College of Medicine
Gainsville, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection
Time frame: 90 or 104 days
Standard audiological evaluations
Pure tone audiometry, tympanometry, otoscopy, tinnitus loudness match
Time frame: 90 or 104 days
Questionnaires evaluating the impact of tinnitus
Patient global impression of change scale, subjective tinnitus annoyance and loudness, tinnitus handicap questionaire
Time frame: 90 or 104 days
Pharmacokinetic measures
Time frame: 3 or 14 days
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