Status:
COMPLETED
SPI-1005 for the Treatment of Meniere's Disease
Lead Sponsor:
Sound Pharmaceuticals, Incorporated
Conditions:
Meniere Disease
Ménière
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2024
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT04677972
Start Date
August 2 2022
End Date
July 25 2024
Last Update
August 1 2024
Active Locations (12)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
University of Southern California
Los Angeles, California, United States, 90033
3
House Clinic
Los Angeles, California, United States, 90057
4
Sacramento Ear, Nose, & Throat
Roseville, California, United States, 95661