Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease
NCT ID: NCT04815187
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
39 participants
INTERVENTIONAL
2021-06-07
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Montelukast 10 mg
Subjects will be instructed to take one pill at night for 90 days
Montelukast
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.
Placebo
Subjects will be instructed to take one pill at night for 90 days
Placebo
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.
Interventions
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Montelukast
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.
Placebo
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.
Eligibility Criteria
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Inclusion Criteria
* Must meet all AAO-HNS 2020 criteria for definite or probable 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
* 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
18 Years
ALL
No
Sponsors
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House Ear Institute
OTHER
Cures Within Reach
OTHER
Responsible Party
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Principal Investigators
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Mary J Derebery, MD
Role: PRINCIPAL_INVESTIGATOR
House Institute Foundation
Locations
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House Ear Clinic
Los Angeles, California, United States
House Institute Foundation
Los Angeles, California, United States
Countries
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Other Identifiers
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20203338
Identifier Type: -
Identifier Source: org_study_id
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