NCT02040194

AM-101 in the Treatment of Acute Tinnitus 3

Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 3

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 893 (actual)
• Sponsor: Auris Medical AG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 or within the last \>3 to 6 months.

Detailed description

This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated intratympanic AM-101 injections in the treatment of acute peripheral tinnitus (up to 3 months (Stratum A), or between \>3 and 6 months (Stratum B) from onset).

Conditions

• Tinnitus

Interventions

Type	Name	Description
DRUG	AM-101	AM-101 gel for intratympanic injection
DRUG	Placebo	Placebo gel for intratympanic injection

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-12-28
• Completion: 2017-12-28
• First posted: 2014-01-20
• Last updated: 2023-09-14

Locations

1 site across 1 country: Germany