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NCT04677972 · ClinicalTrials.gov registry record · Phase 3

SPI-1005 for the Treatment of Meniere's Disease

A Phase 3 study of Meniere Disease and Ménière, sponsored by Sound Pharmaceuticals, Incorporated.

Completed
Registry status
Phase 3
Development phase
254
Enrollment target
12
Study locations

NCT04677972 is a Phase 3 study of Meniere Disease and Ménière that has completed, run by Sound Pharmaceuticals, Incorporated. The registered enrollment target is 254 participants, above the 31-participant average among 3 other Meniere Disease trials with a reported enrollment target (719% higher). The trial reports 12 study locations across 10 states.

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The verdict

NCT04677972, a Phase 3 study of Meniere Disease and Ménière, has completed, sponsored by Sound Pharmaceuticals, Incorporated.

COMPLETED
Registry status
Phase 3
Development phase
254 participants
Enrollment target
12
Study locations

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.

Interventions

  • DRUG Placebo
  • DRUG Ebselen

Study Locations (12)

California

  • University of Southern California - Los Angeles
  • House Clinic - Los Angeles
  • Sacramento Ear, Nose, & Throat - Roseville

Arkansas

  • University of Arkansas for Medical Sciences - Little Rock

District of Columbia

  • George Washington University - Washington D.C.

Florida

  • ENT and Allergy Associates of Florida - Boca Raton

Indiana

  • Indiana University - Indianapolis

Kansas

  • Kansas University Medical Center - Kansas City

Kentucky

  • Advanced ENT & Allergy - Louisville

North Carolina

  • Piedmont Ear, Nose & Throat Associates - Winston-Salem

Trial Details

FieldValue
Enrollment Target 254 participants
Start Date 2022-08-02
Est. Completion 2024-07-25
Phase Phase 3

What the Registry Record Tells You About NCT04677972

The ClinicalTrials.gov registry entry for NCT04677972 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 254 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 31-participant average among 3 other Meniere Disease trials with a reported enrollment target (719% higher). The listed sponsor is Sound Pharmaceuticals, Incorporated, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Meniere Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04677972 reports 12 study locations spanning 10 distinct geographic areas - top geographies include California, Arkansas, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT04677972 about?

NCT04677972 is a clinical study titled "SPI-1005 for the Treatment of Meniere's Disease". 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.

What is the current status of trial NCT04677972?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 254 participants. The study started on 2022-08-02. Estimated completion is 2024-07-25.

What conditions does trial NCT04677972 study?

This clinical trial studies the following conditions: Meniere Disease, Ménière.

What interventions are being tested in trial NCT04677972?

The interventions under investigation include: Placebo (DRUG), Ebselen (DRUG).

Who is sponsoring clinical trial NCT04677972?

This trial is sponsored by Sound Pharmaceuticals, Incorporated, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04677972 being conducted?

This trial has 12 study locations across Arkansas, California, District of Columbia, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.