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 4 to 6 months.
TACTT3 (AT, BE, FR, DE, HU, PL, CH, UK, ES):
Tinnitus onset no longer than 3 months (Stratum A) or between 3 months and 6 months (Stratum B) prior to randomization
Estimated Enrollment: 600
Study Start Date: January 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)