Open-Label Study of SPI-1005 for the Treatment of Meniere's Disease
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Study of the safety of open-label SPI-1005 400 mg BID treatment in adults with Meniere's Disease (MD) for 6 or 12 months to support chronic or chronic intermittent use.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Adult males/females, 18-75 years of age at the time of enrollment.
• Diagnosis of probable or definite Meniere's Disease by AAO-HNS Amended 2015 Criteria.
• At least two of three active symptoms (fluctuating hearing; tinnitus; aural fullness; vertigo or dizziness) of Meniere's disease, within 3 months of study enrollment.
• Type A tympanogram at screening.
• Air conduction thresholds ≤ 90 dB at all tested frequencies (250-8000 Hz) in both ears.
• Subject is willing and able to provide informed consent and perform study procedures and assessments per protocol.