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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of SPI-1005 in Meniere's Disease and Open Label Extension Study to Evaluate the Chronic Safety of SPI-1005

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of SPI-1005 in Meniere's Disease and Open Label Extension Study to Evaluate the Chronic Safety of SPI-1005

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Feb 2025

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At a glance

  • Drugs Ebselen (Primary)
  • Indications Meniere's disease
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms STOPMD-3
  • Sponsors Sound Pharmaceuticals

Most Recent Events

  • 20 Feb 2025 According to a Sound Pharmaceuticals media release, company will present data from this study at Pharmaceutical Interventions for Hearing Loss (PIHL) Satellite Symposium on Friday, Feb 21, at 1-5pm ET.
  • 10 Dec 2024 According to a Sound Pharmaceuticals media release ,company announce that the pivotal Phase 3 clinical trial involving SPI-1005, a novel anti-inflammatory compound (ebselen), for the treatment of Menieres Disease (STOPMD-3), achieved its co-primary endpoints for efficacy involving improvements in hearing loss and speech discrimination.
  • 10 Dec 2024 According to a Sound Pharmaceuticals media release, Primary endpoint (Change in low frequency hearing thresholds measured by pure tone audiometry) has been met.

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