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Completed Phase 3 Interventional Results available

SPI-1005 for the Treatment of Meniere's Disease

ClinicalTrials.gov ID: NCT04677972

Public ClinicalTrials.gov record NCT04677972. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 2:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04677972
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
220 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 1, 2022
Primary completion
Sep 18, 2023
Completion
Jul 24, 2024
Last update posted
Jul 22, 2026

2022 – 2024

United States locations

U.S. sites
12
U.S. states
10
U.S. cities
11
Facility City State ZIP Site status
University of Arkansas for Medical Sciences Little Rock Arkansas 72205
University of Southern California Los Angeles California 90033
House Clinic Los Angeles California 90057
Sacramento Ear, Nose, & Throat Roseville California 95661
George Washington University Washington D.C. District of Columbia 20037
ENT and Allergy Associates of Florida Boca Raton Florida 33487
Indiana University Indianapolis Indiana 46202
Kansas University Medical Center Kansas City Kansas 66160
Advanced ENT & Allergy Louisville Kentucky 40207
Piedmont Ear, Nose & Throat Associates Winston-Salem North Carolina 27103
Thomas Jefferson University Philadelphia Pennsylvania 19144
Medical University of South Carolina Charleston South Carolina 29425

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04677972, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 22, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04677972 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →