Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease

NCT03664674 ↗

Phase 3 Completed 148 enrolled Otonomy, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.

Timeline

Start: 2018-08-27
Primary completion: 2020-12-22
Completion: 2020-12-22

Outcome

Missed primary endpoint

registry analysis (superiority test); OTO-104 Intent to Treat vs Placebo Intent to Treat; p = 0.312; Mean Difference (Net) -0.221 (95% CI -0.648 to 0.207) NCT03664674 ↗

Publications

Phillips J, Mikulec AA, Robinson JM, Skarinsky D, Anderson JJ. Efficacy of Intratympanic OTO-104 for the Treatment of Meniere's Disease: The Outcome of Three Randomized, Double-Blind, Placebo-Controlled Studies. Otol Neurotol. 2023 Jul 1;44(6):584-592. doi: 10.1097/MAO.0000000000003886. Epub 2023 Apr 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexamethasone	Small molecule	12 mg	Other