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

NCT04815187 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 20203338
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Meniere Disease; Allergic Rhinitis; Vertigo

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Montelukast 10 mg

EXPERIMENTAL

Subjects will be instructed to take one pill at night for 90 days

Drug: Montelukast

Placebo

PLACEBO COMPARATOR

Subjects will be instructed to take one pill at night for 90 days

Drug: Placebo

Interventions

Montelukast DRUG

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.

Montelukast 10 mg

Placebo DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• House Ear Institute: lead
• Cures Within Reach: collaborator

Study Sites (2)

House Ear Clinic

Los Angeles, California, 90057, United States

Location

House Institute Foundation

Los Angeles, California, 90057, United States

Location

MeSH Terms

Conditions

Meniere Disease; Rhinitis, Allergic; Vertigo

Interventions

montelukast

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Vestibular Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary J Derebery, MD

  House Institute Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 24, 2021
• Study Start: June 7, 2021
• Primary Completion: September 3, 2025
• Study Completion: December 31, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)