Trial Profile

A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 30 Jun 2023

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At a glance

Drugs Dexamethasone (Primary)
Indications Meniere's disease
Focus Registrational; Therapeutic Use
Acronyms AVERTS-1
Sponsors Otonomy [CEASED]

Most Recent Events

01 Jul 2023 Results assessing the efficacy of intratympanic OTO-104 for the treatment of Meniere's disease from NCT02717442, NCT02612337, NCT03664674 studies, published in the Otology and Neurotology.
30 Aug 2017 Results published in an Otonomy media release.
30 Aug 2017 Primary endpoint has not been met. (Reduction in number of definitive vertigo days compared to placebo), according to an Otonomy media release.

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