Conditions: Tinnitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 343
Healthy volunteers: no

Brief summary:
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.

Detailed description:
This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated intratymanic AM-101 injections in the treatment of acute peripheral tinnitus (up to 3 months from onset).

Arms:
arm 1: AM-101 arm 2: Placebo

Interventions: intervention 1: AM-101 intervention 2: Placebo
Intervention descriptions: intervention 1: AM-101 gel for intratympanic injection intervention 2: Placebo gel for intratympanic injection

Protocol document: