NCT04677972

SPI-1005 for the Treatment of Meniere's Disease

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: Sound Pharmaceuticals, Incorporated · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Meniere Disease
• Ménière

Interventions

Type	Name	Description
DRUG	Ebselen	Glutathione peroxidase mimetic
DRUG	Placebo	Matching placebo containing excipients

Timeline

• Start date: 2022-08-02
• Primary completion: 2023-09-19
• Completion: 2024-07-25
• First posted: 2020-12-21
• Last updated: 2024-08-01

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study