Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCSD UCSF
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

  • UCSD
    San Diego California 92093 United States
  • UCSF
    San Francisco California 94115 United States
  • House Clinic
    Los Angeles California 90057 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Sound Pharmaceuticals, Incorporated
ID
NCT04677972
Phase
Phase 3
Study Type
Interventional
Last Updated