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

Last updated: December 9, 2022
Sponsor: Sound Pharmaceuticals Inc
Overall Status: Active - Recruiting

Phase

3

Condition

Hearing Impairment

Treatment

N/A

Clinical Study ID

TX310282
SPI-1005-351
  • Ages 18-75
  • All Genders

Study Summary

The goal of this study is to find out if the study product is safe and effective at treating the symptoms of Meniere's disease

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Adult males/females, 18-75 years of age at the time of enrollment.
  • Diagnosis of definite Meniere’s Disease by AAO-HNS Amended 2015 Criteria.
  • Hearing loss of ≥30 dB at 250, 500, or 1000 Hz at study enrollment.

Exclusion

Exclusion Criteria

  • History of otosclerosis or vestibular schwannoma.
  • History of significant middle ear or inner ear surgery in the affected ear.
  • Conductive hearing loss with air-bone gap ≥15 dB, otitis media, or mixed hearing loss.

Study Design

Study Start date:
Estimated Completion Date:

Study Description

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

Connect with a study center

  • Piedmont Ear, Nose, and Throat Associates

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

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