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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04815187
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
Cures Within Reach
Information provided by (Responsible Party):
House Ear Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Meniere Disease Allergic Rhinitis Vertigo Drug: Montelukast Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 18 years of age or older
  • Must meet all AAO-HNS 2020 criteria for definite 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04815187


Contacts
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Contact: Mahta Marefat (213) 770-1808 clinicaltrials@hifla.org

Locations
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United States, California
House Ear Clinic Recruiting
Los Angeles, California, United States, 90057
Contact: Mahta Marefat    213-770-1808    clinicaltrials@hifla.org   
Principal Investigator: Mary J Derebery, MD         
House Institute Foundation Recruiting
Los Angeles, California, United States, 90057
Contact: Mahta Marefat    213-770-1808    clinicaltrials@hifla.org   
Sponsors and Collaborators
House Ear Institute
Cures Within Reach
Investigators
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Principal Investigator: Mary J Derebery, MD House Ear Clinic/House Institute Foundation
More Information
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Responsible Party: House Ear Institute
ClinicalTrials.gov Identifier: NCT04815187    
Other Study ID Numbers: 20203338
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Hearing Loss
Vertigo
Meniere Disease
Dizziness
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Hearing Disorders
Ear Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Vestibular Diseases
Labyrinth Diseases
Endolymphatic Hydrops
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs