SPI-1005 for the Treatment of Meniere's Disease (STOPMD-3)
S
Sarah Jo Mcdaniel Burgin
Primary Investigator
Administratively Closed
18 years - 75 years
All
Phase
3
200 participants needed
3 Locations
Brief description of study
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 definitedisease with active symptoms within three months preceding study enrollment.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Meniere Disease, Ménière
-
Age: 18 years - 75 years
-
Gender: All
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)disease by AAO-HNS Amended 2015 Criteria, within 3 months of study.
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,docrine, 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.
Updated on
28 Oct 2024.
Study ID: SPI-1005-351, OTHN-SOUND-SPI-1005, 17365
