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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: Recruiting Phase 3 study of Meniere's Disease and Ménière's Disease, sponsored by Sound Pharmaceuticals, Incorporated.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety and tolerability assessed based on adverse events
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 |
What NCT06859788 shows while recruiting
NCT06859788 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
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 lists 8 locations in 6 states (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.
Learn More About Clinical Trials
Similar trials for Meniere's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06859788's enrollment target sits among peer trials
200 1354th of 2000 higher than 613 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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