Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease

Study Overview
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Brief Summary
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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.

Official Title
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Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease

Conditions
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Meniere Disease, Allergic Rhinitis, Vertigo

Intervention / Treatment
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* Drug: Montelukast
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 years of age or older Must meet all AAO-HNS 2020 criteria for definite Meniere's Disease Must have a skin test positive for allergy Is already a candidate for treatment with montelukast for allergic rhinitis/failed first line over-the-counter allergy treatments Exclusion Criteria: Had a previous surgical procedure for treatment of vertigo Currently receiving any allergy immunotherapy or taking montelukast or a beta-blocker Pregnant or recent pregnancy ((≤ 8 weeks postpartum), or lactation) Current hospitalization for any reason Any active, acute, or chronic pulmonary disorder other than asthma History of intubation for asthma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montelukast 10 mg<br>Subjects will be instructed to take one pill at night for 90 days | Drug: Montelukast<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Subjects will be instructed to take one pill at night for 90 days | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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. | 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. | 3 months after treatment initiation |