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Leukotriene Modifier

Montelukast for Vertigo

Phase 4
Recruiting
Led By Mary J Derebery, MD
Research Sponsored by House Ear Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is already a candidate for treatment with montelukast for allergic rhinitis/failed first line over-the-counter allergy treatments
Must meet all AAO-HNS 2020 criteria for definite Meniere's Disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after treatment initiation
Awards & highlights

Study Summary

"This trial aims to test if a medication, already approved by the FDA for allergies, can reduce symptoms in patients with Meniere's Disease."

Who is the study for?
This trial is for adults over 18 with definite Meniere's Disease, as per AAO-HNS 2020 criteria, who also test positive for allergies and have not had success with standard allergy treatments. It's specifically aimed at those already considered for montelukast therapy.Check my eligibility
What is being tested?
The study tests whether montelukast, a drug approved for allergic rhinitis and asthma, can alleviate vertigo and hearing loss in Meniere's Disease patients. Participants will either receive montelukast or a placebo to compare outcomes.See study design
What are the potential side effects?
Montelukast may cause side effects like headaches, stomach pain, heartburn, fatigue, dizziness (which could be confusing given the condition), and in rare cases mood changes or sleep disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a candidate for montelukast due to my severe allergies.
Select...
I have been diagnosed with definite Meniere's Disease according to AAO-HNS 2020 criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after treatment initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after treatment initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in Dizziness Between Treatment Arms
Percentage of Patients with AAO-HNS Vertigo Control Class A or B
Percentage of Subjects Experiencing Significant Hearing Fluctuation

Side effects data

From 2005 Phase 4 trial • 99 Patients • NCT00189462
16%
Cold/Upper Respiratory Infection
10%
Diarrhea
6%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Montelukast
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Montelukast 10 mgExperimental Treatment1 Intervention
Subjects will be instructed to take one pill at night for 90 days
Group II: PlaceboPlacebo Group1 Intervention
Subjects will be instructed to take one pill at night for 90 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Montelukast
FDA approved

Find a Location

Who is running the clinical trial?

House Ear InstituteLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Cures Within ReachOTHER
19 Previous Clinical Trials
1,703 Total Patients Enrolled
1 Trials studying Vertigo
34 Patients Enrolled for Vertigo
Mary J Derebery, MDPrincipal InvestigatorHouse Institute Foundation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
House Ear Clinic
House Institute Foundation
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

Montelukast is one of the only things that's helped with my vertigo.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. House Institute Foundation: < 48 hours
Average response time
  • < 2 Days
~12 spots leftby Jun 2025