SPI-1005 for the Treatment of Meniere's Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Meniere Disease, Ménière

In brief

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.

Key facts

Study ID

NCT04677972

Run by

Sound Pharmaceuticals, Incorporated

People needed

220

Starts

2022-08-02

Expected to finish

2024-07-25

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult males/females, 18-75 years of age at the time of enrollment.
• Diagnosis of definite Meniere's Disease by AAO-HNS Amended 2015 Criteria.
• Hearing loss of ≥30 dB at 250, 500, or 1000 Hz at study enrollment.
• At least two of three active symptoms (tinnitus; aural fullness; vertigo or dizziness) of Meniere's disease by AAO-HNS Amended 2015 Criteria, within 3 months of study enrollment.

You may not qualify if…

• Current, or within 60 days prior to study enrollment, use of IV ototoxic medications
• History of otosclerosis or vestibular schwannoma.
• History of significant middle ear or inner ear surgery in the affected ear.
• Conductive hearing loss with air-bone gap ≥15 dB, otitis media, or mixed hearing loss.
• Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease.
• Current use or within 30 days prior to study enrollment systemic steroids.
• Current use or within 7 days prior to study enrollment intratympanic steroids.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• University of Southern California — Los Angeles, California, United States
• House Clinic — Los Angeles, California, United States
• Sacramento Ear, Nose, & Throat — Roseville, California, United States
• George Washington University — Washington D.C., District of Columbia, United States
• ENT and Allergy Associates of Florida — Boca Raton, Florida, United States
• Indiana University — Indianapolis, Indiana, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Advanced ENT & Allergy — Louisville, Kentucky, United States
• Piedmont Ear, Nose & Throat Associates — Winston-Salem, North Carolina, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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