Meniere DiseasePhase 4NCT04815187
Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease
A Phase 4 study testing Montelukast in people with Meniere Disease and Allergic Rhinitis, run by House Ear Institute at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniere Disease, Allergic Rhinitis, Vertigo
- What is being tested?
- Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jun 2021to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
House Ear Clinic
Los Angeles, California, 90057
House Institute Foundation
Los Angeles, California, 90057
About this study
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.
- Conditions
- Meniere Disease, Allergic Rhinitis, Vertigo
- Being tested
- Montelukast, Placebo
- Medical subject headings
- Meniere Disease, Rhinitis, Allergic, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Montelukast 10 mg | Experimental | Subjects will be instructed to take one pill at night for 90 days Receives: Drug: Montelukast |
| Placebo | Placebo comparator | Subjects will be instructed to take one pill at night for 90 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 month after treatment initiation
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)
Measured: 3 months after treatment initiation
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)
Measured: 6 months after treatment initiation
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.
Measured: 3 months after treatment initiation
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.
Measured: 3 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start7 Jun 2021
- Primary completion3 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniere DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- House Ear Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cures Within Reach
- Responsible party
- Sponsor
- Investigators
- Mary J Derebery, MD, Principal investigator, House Institute Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815187
- Sponsor's protocol ID
- 20203338
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2021
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease
- ClinicalTrials.gov ID
- NCT04815187
- Acronym / sponsor ID
- 20203338
- Conditions
- Meniere Disease, Allergic Rhinitis, Vertigo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- House Ear InstituteUniversity, hospital or other
- Collaborators
- Cures Within Reach
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 3 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast 10 mg | Experimental | Drug: MontelukastSubjects will be instructed to take one pill at night for 90 days |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will be instructed to take one pill at night for 90 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MontelukastEach 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. | Drug | Montelukast 10 mg |
| PlaceboEach 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. | Drug | Placebo |
Primary outcome
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)
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)
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)
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary J Derebery, MD principal investigator
House Institute Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Montelukast in people with Meniere Disease and Allergic Rhinitis, run by House Ear Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients with AAO-HNS Vertigo Control Class A or B (time frame: 1 month after treatment initiation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.