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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: Completed Phase 3 study of Meniere Disease and Ménière, sponsored by Sound Pharmaceuticals, Incorporated.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2022-08-02 |
| Est. Completion | 2024-07-25 |
| Phase | Phase 3 |
What the finished NCT04677972 record still lists
NCT04677972 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, above the 31-participant average among 3 other Meniere Disease trials with a reported enrollment target (719% higher).
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 lists 12 locations in 10 states (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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