Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI-1005 in adult subjects with definite Meniere's disease with active symptoms within three months preceding study enrollment.

Official Title

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

Keywords

Meniere Disease, Ménière, ebselen, hearing loss, tinnitus, vertigo, dizziness, SPI-1005, SPI-1005 400 mg BID

Eligibility

You can join if…

Open to people ages 18-75

  • 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.
  • At least two of three active symptoms (tinnitus; aural fullness; vertigo or dizziness) of Meniere's disease by AAO-HNS Amended 2015 Criteria, within 3 months of study enrollment.

You CAN'T join if...

  • Current, or within 60 days prior to study enrollment, use of IV ototoxic medications
  • 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.
  • Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease.
  • Current use or within 30 days prior to study enrollment systemic steroids.
  • Current use or within 7 days prior to study enrollment intratympanic steroids.

Locations

  • University of California San Diego not yet accepting patients
    San Diego California 92093 United States
  • University of California Irvine not yet accepting patients
    Irvine California 92604 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Sound Pharmaceuticals, Incorporated
ID
NCT04677972
Phase
Phase 3 Meniere's Disease Research Study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated