SPI-1005 for the Treatment of Meniere's Disease (Open Label)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Sound Pharmaceuticals, Incorporated
Study ID
NCT06859788
Phase
PHASE3
Status
Recruiting
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Conditions

  • Meniere's Disease
  • Ménière's Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ebselen — DRUG
    Glutathione peroxidase mimetic

Study Details

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.

Key Dates

Start date
Oct 29, 2025
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open Label
    Oral administration of SPI-1005 400 mg BID

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [ Time Frame: 180 and 360 days ]

Locations (9)

FacilityCityStateZIPSite coordinators
The House InstituteLos AngelesCalifornia90057
Study Coordinator
[email protected]
(213) 443-8193
ENT and Allergy Associates of FloridaBoynton BeachFlorida33471
Clinical Research Supervisor
[email protected]
954-575-9301
ENT and Allergy Associates of FloridaDelray BeachFlorida33484
Clinical Research Supervisor
[email protected]
(561) 939 - 0186
Northwell HealthNew Hyde ParkNew York11042
Clinical Research Manager
[email protected]
718-470-7974
ENT and Allergy Associates, LLPNew YorkNew York10017
Ginny Mullooly
[email protected]
718-470-7974
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Maya Childs
[email protected]
(215) 955-6760
Medical University of South CarolinaCharlestonSouth Carolina29425
Research Director
[email protected]
(843)792-1356
University of Texas SouthwesternDallasTexas75390
Paula Arellano-Cruz
[email protected]
214-648-8096
Medical College of WisconsinMilwaukeeWisconsin53226
Clinical Research Coordinator
[email protected]
414.955.0822

Find similar trials in Los Angeles, CA

By research site
The House Institute· Los Angeles, CAENT and Allergy Associates of Florida· Boynton Beach, FLENT and Allergy Associates of Florida· Delray Beach, FLNorthwell Health· New Hyde Park, NYENT and Allergy Associates, LLP· New York, NYThomas Jefferson University· Philadelphia, PA

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