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NCT06859788 · ClinicalTrials.gov registry record · Phase 3
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
A Phase 3 study of Meniere's Disease and Ménière's Disease, sponsored by Sound Pharmaceuticals, Incorporated.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 8
- Study locations
NCT06859788 is a Phase 3 study of Meniere's Disease and Ménière's Disease that is actively recruiting participants, run by Sound Pharmaceuticals, Incorporated. The registered enrollment target is 200 participants. The trial reports 8 study locations across 6 states.
The verdict
NCT06859788, a Phase 3 study of Meniere's Disease and Ménière's Disease, is actively recruiting participants, sponsored by Sound Pharmaceuticals, Incorporated.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 8
- Study locations
Study Summary
Study of the safety of open-label SPI-1005 400 mg BID treatment in adults with Meniere's Disease (MD) for 6 or 12 months to support chronic or chronic intermittent use.
Conditions Studied
Interventions
- DRUG Ebselen
Study Locations (8)
Florida
- ENT and Allergy Associates of Florida - Boca Raton
- University of Miami - Miami
New York
- Northwell Health - New Hyde Park
- ENT and Allergy Associates, LLP - New York
California
- The House Institute - Los Angeles
South Carolina
- Medical University of South Carolina - Charleston
Texas
- University of Texas Southwestern - Dallas
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-10-29 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06859788
The ClinicalTrials.gov registry entry for NCT06859788 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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's Disease appearing as the primary indexed condition, and to 1 intervention - of which Ebselen is the first listed.
NCT06859788 reports 8 study locations spanning 6 distinct geographic areas - top geographies include Florida, New York, California.
Frequently Asked Questions
What is clinical trial NCT06859788 about?
NCT06859788 is a clinical study titled "SPI-1005 for the Treatment of Meniere's Disease (Open Label)". Study of the safety of open-label SPI-1005 400 mg BID treatment in adults with Meniere's Disease (MD) for 6 or 12 months to support chronic or chronic intermittent use.
What is the current status of trial NCT06859788?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2025-10-29. Estimated completion is 2026-12.
What conditions does trial NCT06859788 study?
This clinical trial studies the following conditions: Meniere's Disease, Ménière's Disease.
What interventions are being tested in trial NCT06859788?
The interventions under investigation include: Ebselen (DRUG).
Who is sponsoring clinical trial NCT06859788?
This trial is sponsored by Sound Pharmaceuticals, Incorporated, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06859788 being conducted?
This trial has 8 study locations across California, Florida, New York, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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