STOPMD-3: SPI-1005 (ebselen) Phase 3 in Meniere's disease — company-reported results
Record details
- Authors: —
- Journal / source: Company announcement (not yet peer-reviewed) (2024)
- Design: Phase 3 RCT + open-label extension
- Sample: 221
- Primary endpoint: Hearing/speech discrimination (co-primary)
- Randomized: Yes · Sham/placebo-controlled: Yes · Independent of the manufacturer: No
What this research found
Sponsor reports co-primary endpoints met; in the OPEN-LABEL extension, patient-reported tinnitus, vertigo and aural fullness improved ≥30% from baseline (p<0.001). Peer-reviewed publication not yet located — treat as company-reported.
FDA Breakthrough Therapy designation granted December 1, 2025 — for HEARING LOSS in Meniere's disease, not for tinnitus. PubMed check (Sept 2026): still no peer-reviewed STOPMD-3 publication.
Limitations and conflicts of interest
Unblinded tinnitus data; Meniere's population, not primary tinnitus.
Funding / conflicts: Sponsor press release.
Primary sources
Used as evidence for
This is an original summary from the Tinnitus Evidence verified database, checked against the primary source — not a reproduction of the publisher's abstract.