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NCT02603081
PHASE1/PHASE2

Study to Evaluate SPI-1005 in Adults With Meniere's Disease

Sponsor: Sound Pharmaceuticals, Incorporated

View on ClinicalTrials.gov

Summary

This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's disease.

Official title: Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of SPI-1005 in Meniere's Disease

Key Details

Gender

All

Age Range

19 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2015-12

Completion Date

2017-08

Last Updated

2026-06-29

Healthy Volunteers

No

Interventions

DRUG

SPI-1005

Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.

Locations (5)

House Clinic

Los Angeles, California, United States

New York Otology

New York, New York, United States

MUSC

Charleston, South Carolina, United States

Sound Pharmaceuticals, Inc.

Seattle, Washington, United States

Northwest Ear

Seattle, Washington, United States