AM-101 in the Treatment of Acute Tinnitus 2

Phase 3 Completed 343 enrolled Auris Medical AG

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2014-02
Primary completion: 2016-06
Completion: 2016-06

Outcome

Missed primary endpoint

registry analysis (superiority test); AM-101 0.87 mg/mL Gel vs Placebo Gel; p = 0.32; Mean Difference (Net) -0.17 (95% CI -0.51 to 0.17) NCT01803646 ↗

registry analysis (superiority test); AM-101 0.87 mg/mL Gel vs Placebo Gel; p = 0.63; Mean Difference (Net) -0.79 (95% CI -4 to 2.4) NCT01803646 ↗

Publications

Results Staecker H, Morelock M, Kramer T, Chrbolka P, Ahn JH, Meyer T. Safety of Repeated-Dose Intratympanic Injections with AM-101 in Acute Inner Ear Tinnitus. Otolaryngol Head Neck Surg. 2017 Sep;157(3):478-487. doi: 10.1177/0194599817711378. Epub 2017 Jun 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Esketamine	Other / unclassified	0.87 mg/ml	Other