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

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 Overview

• Status: Active, not recruiting
• Conditions: Allergic Rhinitis; Vertigo; Meniere Disease
• Intervention / Treatment: Drug: Montelukast; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90057
      • House Ear Clinic
    • Los Angeles, California, United States, 90057
      • House Institute Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: House Ear Institute
• Collaborators: Cures Within Reach
• Investigators: Principal Investigator: Mary J Derebery, MD, House Institute Foundation

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Estimated): September 3, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Endolymphatic Hydrops; Hearing Disorders; Labyrinth Diseases; Vestibular Diseases; Meniere Disease; Hearing Loss; Rhinitis; Rhinitis, Allergic; Vertigo; Dizziness; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Respiratory System Agents; Anti-Asthmatic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP1A2 Inducers; Leukotriene Antagonists; Montelukast
• Other Study ID Numbers: 20203338

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No