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

Phase 4

Active, not recruiting

• Conditions: Vertigo; Meniere Disease; Allergic Rhinitis
• Interventions: Drug: Placebo; Drug: Montelukast

• Registration Number: NCT04815187
• Lead Sponsor: House Ear Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-24
• Study Start: 2021-06-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-09-03
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Adults 18 years of age or older
• 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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will be instructed to take one pill at night for 90 days
Montelukast 10 mg	Montelukast	Subjects will be instructed to take one pill at night for 90 days

Primary Outcome Measures

Name	Time	Method
Percentage of Patients with AAO-HNS Vertigo Control Class A or B	6 months after treatment initiation	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)
Difference in Dizziness Between Treatment Arms	3 months after treatment initiation	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.
Percentage of Subjects Experiencing Significant Hearing Fluctuation	3 months after treatment initiation	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.

Trial Locations

Locations (2)

House Ear Clinic; 🇺🇸 Los Angeles, California, United States

House Institute Foundation; 🇺🇸 Los Angeles, California, United States