SPI-1005 for the Treatment of Meniere's Disease

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of SPI-1005 in Meniere's Disease and Open Label Extension Study to Evaluate the Chronic Safety of SPI-1005

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.

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.