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A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy of SPI-1005 in Meniere's Disease

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Trial Profile

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy of SPI-1005 in Meniere's Disease

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 19 Sep 2023

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At a glance

  • Drugs Ebselen (Primary)
  • Indications Meniere's disease
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Sound Pharmaceuticals

    • Most Recent Events

    • 18 Sep 2019 According to a Sound Pharmaceuticals media release, on the basis of this and othe study (263174), the FDA's Division of Neurology Products has granted Fast Track Designation to SPI-1005 in the treatment of Meniere's Disease.
    • 25 Jun 2019 According to a Sound Pharmaceuticals media release, more detailed presentation of the ITT and Per-Protocol analyses will occur at a scientific meeting later in 2019.
    • 25 Jun 2019 Topline results at week-8 published in the Sound Pharmaceuticals Media Release

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