The purpose of this study is to evaluate a previously FDA-approved medication that is known to help with allergy symptoms to see if it can decrease symptoms in patients with Meniere's Disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
39
Each subject will be given a drug diary to record when they took the drug and any symptoms that they are experiencing, and will bring this diary and any unused pills to their next clinic visit before receiving the next 30-day supply. This process will continue for the full 90 days of study involvement, with a final visit 3 months later.
Each subject will be given a drug diary to record when they took the drug and any symptoms that they are experiencing, and will bring this diary and any unused pills to their next clinic visit before receiving the next 30-day supply. This process will continue for the full 90 days of study involvement, with a final visit 3 months later.
House Ear Clinic
Los Angeles, California, United States
House Institute Foundation
Los Angeles, California, United States
Percentage of Patients with AAO-HNS Vertigo Control Class A or B
Percentage of patients in each group with an AAO-HNS Vertigo Control Class A or B result (from daily diary count of number of attacks)
Time frame: 1 month after treatment initiation
Percentage of Patients with AAO-HNS Vertigo Control Class A or B
Percentage of patients in each group with an AAO-HNS Vertigo Control Class A or B result (from daily diary count of number of attacks)
Time frame: 3 months after treatment initiation
Percentage of Patients with AAO-HNS Vertigo Control Class A or B
Percentage of patients in each group with an AAO-HNS Vertigo Control Class A or B result (from daily diary count of number of attacks)
Time frame: 6 months after treatment initiation
Difference in Dizziness Between Treatment Arms
Difference for each group in AAO-HNS dizziness functional disability scale from pre-treatment to 3 months after treatment initiation. A score improvement of 1 point on this 6-point scale will be considered significant improvement.
Time frame: 3 months after treatment initiation
Percentage of Subjects Experiencing Significant Hearing Fluctuation
Percentage of subjects in each treatment arm demonstrating clinically significant change in air conduction thresholds at \> 2 frequencies at 3 months (\> 10 dB change from baseline) or WDS (\> 15% change from baseline) compared to the worst audiogram and WDS in the 6 months prior to treatment initiation.
Time frame: 3 months after treatment initiation
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