What side effects are associated with this type of intervention?

Common treatments for vertigo, particularly antihistamines, can cause side effects such as drowsiness, dry mouth, blurred vision, constipation, and urinary retention. Some patients may also experience dizziness, headache, or gastrointestinal discomfort. These side effects are generally mild but can vary depending on the specific medication and individual response.

What prior FDA approvals exist?

The FDA has approved several antihistamines for the treatment of vertigo, particularly those associated with Meniere's Disease. These include medications like meclizine and dimenhydrinate, which function by blocking histamine H1 receptors. These drugs help alleviate vertigo symptoms by reducing the effects of histamine, which can contribute to the sensation of dizziness and imbalance.

What other types of research exist?

Promising novel alternatives to antihistamines for vertigo patients in 2024 include the repurposed use of medications initially approved for allergic rhinitis and asthma, such as certain corticosteroids and immunotherapy agents. These drugs have shown potential in reducing vertigo and hearing loss symptoms in conditions like Meniere's Disease. Additionally, advancements in vestibular rehabilitation therapy and the use of precision medicine approaches targeting specific pathways involved in vertigo are also promising.

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Leukotriene Modifier

Montelukast for Meniere's Disease

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

Must not have

Current hospitalization for any reason

Currently receiving any allergy immunotherapy or taking montelukast or a beta-blocker

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after treatment initiation

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing an allergy medicine to see if it can help people with Meniere's Disease by reducing their symptoms.

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.

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.

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

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I am a candidate for montelukast due to my severe allergies.

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I have been diagnosed with definite Meniere's Disease according to AAO-HNS 2020 criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently in the hospital.

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I am currently on allergy shots or taking montelukast or a beta-blocker.

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I have a lung condition that is not asthma.

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I had surgery before to treat dizziness.

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I have been intubated for asthma in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after treatment initiation

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Montelukast

Placebo

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antihistamines, commonly used in the treatment of vertigo, work by blocking H1 histamine receptors, which are involved in the body's allergic response and can influence the inner ear's balance mechanisms. By inhibiting these receptors, antihistamines help reduce dizziness and nausea, key symptoms of vertigo. This mechanism is crucial for vertigo patients as it helps stabilize their condition and significantly improves their quality of life by alleviating the disruptive symptoms associated with vertigo.

Intravenous histamine in otologic practice. Side effects in 2,347 administrations.Evidence and evidence gaps of medical treatment of non-tumorous diseases of the head and neck.Complementary and alternative therapy (CAM) in the treatment of allergic rhinitis.