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

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

Discontinued
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2017

At a glance

  • Drugs Dexamethasone (Primary)
  • Indications Meniere's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms AVERTS-2
  • Sponsors Otonomy
  • Most Recent Events

    • 08 Nov 2017 According to a company media release, Otonomy plans to review the results of this trial with the US FDA and discuss clinical requirements for registration of OTIVIDEX for patients with Meniere's disease. The company expects to provide an update from discussions with the FDA during the first quarter of 2018.
    • 08 Nov 2017 Primary endpoint (Reduction in number of definitive vertigo days compared to placebo as assessed by a daily diary) has been met according to an Otonomy media release.
    • 08 Nov 2017 Top-line results presented in an Otonomy media release.
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