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SPI-1005 for the Treatment of Meniere's Disease
Sponsor: Sound Pharmaceuticals, Incorporated
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
254
Start Date
2022-08-02
Completion Date
2024-07-25
Last Updated
2026-06-26
Healthy Volunteers
No
Conditions
Interventions
Ebselen
Glutathione peroxidase mimetic
Placebo
Matching placebo containing excipients
Locations (12)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of Southern California
Los Angeles, California, United States
House Clinic
Los Angeles, California, United States
Sacramento Ear, Nose, & Throat
Roseville, California, United States
George Washington University
Washington D.C., District of Columbia, United States
ENT and Allergy Associates of Florida
Boca Raton, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Advanced ENT & Allergy
Louisville, Kentucky, United States
Piedmont Ear, Nose & Throat Associates
Winston-Salem, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States