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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04815187
Other study ID # 20203338
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 7, 2021
Est. completion date December 31, 2025

Study information

Verified date February 2024
Source House Ear Institute
Contact Sean Lang
Phone (213) 770-1808
Email clinicaltrials@hifla.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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
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.

Locations

Country Name City State
United States House Ear Clinic Los Angeles California
United States House Institute Foundation Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
House Ear Institute Cures Within Reach

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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