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

Primary Purpose

Meniere Disease, Allergic Rhinitis, Vertigo

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Montelukast
Placebo
Sponsored by
House Ear Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniere Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • House Ear ClinicRecruiting
  • House Institute FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Montelukast 10 mg

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
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)
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)
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 19, 2021
Last Updated
March 29, 2021
Sponsor
House Ear Institute
Collaborators
Cures Within Reach
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1. Study Identification

Unique Protocol Identification Number
NCT04815187
Brief Title
Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease
Official Title
Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
House Ear Institute
Collaborators
Cures Within Reach

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere Disease, Allergic Rhinitis, Vertigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Montelukast 10 mg
Arm Type
Experimental
Arm Description
Subjects will be instructed to take one pill at night for 90 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be instructed to take one pill at night for 90 days
Intervention Type
Drug
Intervention Name(s)
Montelukast
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Percentage of Patients with AAO-HNS Vertigo Control Class A or B
Description
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)
Time Frame
1 month after treatment initiation
Title
Percentage of Patients with AAO-HNS Vertigo Control Class A or B
Description
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)
Time Frame
3 months after treatment initiation
Title
Percentage of Patients with AAO-HNS Vertigo Control Class A or B
Description
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)
Time Frame
6 months after treatment initiation
Title
Difference in Dizziness Between Treatment Arms
Description
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.
Time Frame
3 months after treatment initiation
Title
Percentage of Subjects Experiencing Significant Hearing Fluctuation
Description
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.
Time Frame
3 months after treatment initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahta Marefat
Phone
(213) 770-1808
Email
clinicaltrials@hifla.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary J Derebery, MD
Organizational Affiliation
House Ear Clinic/House Institute Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
House Ear Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahta Marefat
Phone
213-770-1808
Email
clinicaltrials@hifla.org
First Name & Middle Initial & Last Name & Degree
Mary J Derebery, MD
Facility Name
House Institute Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahta Marefat
Phone
213-770-1808
Email
clinicaltrials@hifla.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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