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COMPLETED
NCT04677972
PHASE3

SPI-1005 for the Treatment of Meniere's Disease

Sponsor: Sound Pharmaceuticals, Incorporated

View on ClinicalTrials.gov

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

Interventions

DRUG

Ebselen

Glutathione peroxidase mimetic

DRUG

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