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SPI-1005 for the Treatment of Meniere's Disease

NCT04677972 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2024-08-01

No results posted yet for this study

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

DRUG

Ebselen

Glutathione peroxidase mimetic

DRUG

Placebo

Matching placebo containing excipients

Sponsors & Collaborators

  • Sound Pharmaceuticals, Incorporated

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-02
Primary Completion
2023-09-19
Completion
2024-07-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04677972 on ClinicalTrials.gov