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Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of SPI-1005 in Meniere's Disease

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Trial Profile

Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of SPI-1005 in Meniere's Disease

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 16 Jan 2020

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At a glance

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

Most Recent Events

  • 18 Sep 2019 According to a Sound Pharmaceuticals media release, on the basis of this and othe study (289266), the FDA's Division of Neurology Products has granted Fast Track Designation to SPI-1005 in the treatment of Meniere's Disease.
  • 06 Mar 2019 According to a Sound Pharmaceuticals media release, data from this trial were presented at the Association for Research in Otolaryngology meeting in 2018.
  • 03 Oct 2017 According to a Sound Pharmaceuticals media release, data were submitted for presentation to the Association for Research in Otolaryngology meeting.

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