SPI-1005 for the Treatment of Meniere's Disease (STOPMD-3)

Sound Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Meniere Disease

Ménière

Treatments

Drug: Placebo

Drug: Ebselen

Study type

Interventional

Funder types

Industry

Identifiers

NCT04677972

SPI-1005-351

Details and patient eligibility

About

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.

Enrollment

254 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.