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Active, Not Recruiting

NCT Number: NCT04815187

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

House Ear Clinic, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Percentage of Patients with AAO-HNS Vertigo Control Class A or B

    Time frame: 1 month 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)

  2. Percentage of Patients with AAO-HNS Vertigo Control Class A or B

    Time frame: 3 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)

  3. Percentage of Patients with AAO-HNS Vertigo Control Class A or B

    Time frame: 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)

  4. Difference in Dizziness Between Treatment Arms

    Time frame: 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.

  5. Percentage of Subjects Experiencing Significant Hearing Fluctuation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

House Ear Institute

Other

Collaborators

  • Cures Within Reach

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2021
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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