Montelukast for Meniere's Disease

Not currently recruiting at 1 trial location

Overseen By Sean Lang

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: House Ear Institute

Must not be taking: Montelukast, Beta-blockers

Disqualifiers: Surgical vertigo, Pregnancy, Hospitalization, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether montelukast, a medication typically used for allergies, can aid individuals with Meniere's Disease, which causes dizziness and hearing issues. Participants will receive either montelukast or a placebo (a pill with no active medicine) for 90 days. The trial aims to determine if montelukast can reduce Meniere's Disease symptoms. Suitable candidates have a doctor-confirmed diagnosis of Meniere's Disease, experience allergies, and have not found relief with over-the-counter allergy treatments. As a Phase 4 trial, montelukast is already FDA-approved and proven effective, and this research seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial requires that you are not currently taking montelukast, allergy immunotherapy, or a beta-blocker. If you are on these medications, you would need to stop them to participate.

Will I have to stop taking my current medications?

The trial requires that you are not currently taking montelukast or a beta-blocker, and you cannot be receiving allergy immunotherapy. If you are on these medications, you would need to stop them to participate.

What is the safety track record for Montelukast?

Research has shown that the FDA has approved montelukast for treating allergy symptoms, indicating its safety for that use. Previous studies found that people taking montelukast for allergies generally tolerated it well, with most not experiencing major side effects. A few reported minor issues like headaches or stomach upset, but these were uncommon. Now that montelukast is being tested for Meniere's Disease, its safety record for allergies provides some confidence about its safety for this new use. However, as with any medication, individuals may react differently. Discuss any concerns with a doctor. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for Meniere's disease focus on managing symptoms like dizziness and ringing in the ears, often using diuretics or vestibular suppressants. However, Montelukast is unique because it targets inflammation by blocking leukotrienes, which are chemicals in the body that can cause swelling and fluid buildup. This mechanism offers a fresh approach to treating Meniere's disease by potentially addressing an underlying cause rather than just alleviating symptoms. Researchers are excited about Montelukast because it could lead to longer-term relief and improve quality of life for those affected by this condition.

What evidence suggests that Montelukast might be an effective treatment for Meniere's Disease?

Research has shown that montelukast, a medication already used for allergies, might help with Meniere's Disease. Meniere's Disease affects the inner ear and can cause dizziness, hearing loss, and ringing in the ears. Montelukast may reduce swelling, a problem in both allergies and Meniere's Disease. Previous studies found that only a few patients taking montelukast experienced improved symptoms, but researchers continue to explore its potential benefits. In this trial, participants will receive either montelukast or a placebo to further evaluate its effectiveness for Meniere’s Disease. Current evidence supports the safety of montelukast, but its effectiveness for Meniere’s Disease remains under investigation. ^{1 2 3 4 5}

Who Is on the Research Team?

Mary J Derebery, MD

Principal Investigator

House Institute Foundation

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Must have a skin test positive for allergy

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

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

Exclusion Criteria

I am currently in the hospital.

Pregnant or recent pregnancy (≤ 8 weeks postpartum), or lactation

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take one pill at night for 90 days, either Montelukast 10 mg or placebo

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Montelukast
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Montelukast 10 mg Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Montelukast is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Singulair for:

• Asthma
• Exercise-induced bronchoconstriction
• Allergic rhinitis

Approved in Canada as Singulair for:

• Asthma
• Exercise-induced bronchoconstriction
• Allergic rhinitis

Approved in European Union as Singulair for:

• Asthma
• Exercise-induced bronchoconstriction
• Allergic rhinitis

Who Is Running the Clinical Trial?

House Ear Institute

Lead Sponsor

Trials

2

Recruited

140+

Cures Within Reach

Collaborator

Trials

25

Recruited

2,100+

Published Research Related to This Trial

Montelukast is effective in improving clinical scores and respiratory function in patients with chronic asthma and in preventing effort-induced asthma, based on several placebo-controlled trials.

While montelukast has not been directly compared to all standard treatments for asthma, it may be superior to salmeterol for effort-induced asthma, and it generally has a similar side effect profile to placebo, though rare cases of Churg-Strauss syndrome have been reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Montelukast. No current use for asthma. [2021]

In a randomized, double-blind study involving 38 children aged 2 to 6 years with persistent otitis media with effusion, montelukast did not show any significant effect in clearing middle ear drainage compared to placebo.

After one month of treatment, only 15.8% of patients taking montelukast and 21.1% of those on placebo experienced clearance of effusion, leading to the conclusion that montelukast is not effective for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, randomized, placebo-controlled, double-blind study of montelukast's effect on persistent middle ear effusion. Schoem, SR., Willard, A., Combs, JT.[2021]

Montelukast sodium is a safe and effective oral medication that acts as a leukotriene-receptor antagonist, specifically targeting the CysLT1 receptor, making it useful for preventing asthma and allergic rhinitis in both adults and children.

Clinical trials have demonstrated that montelukast effectively reduces inflammation and symptoms associated with asthma and allergic rhinitis, highlighting its role in managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of montelukast in the treatment of asthma and allergic rhinitis. Nayak, A.[2021]

A study involving 40 healthy male volunteers demonstrated that Sandoz generic montelukast 4 mg oral granules are bioequivalent to Singulair(®) 4 mg mini oral granules, meaning they have similar absorption and effectiveness in the body.

Both formulations showed a comparable safety profile, with only two mild adverse events reported, indicating that they can be used interchangeably in treating asthma and allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioequivalence of two formulations of montelukast sodium 4 mg oral granules in healthy adults. Fey, C., Thyroff-Friesinger, U., Jones, S.[2021]

Montelukast sodium, administered intravenously in doses ranging from 3 to 18 mg, showed linear pharmacokinetics in healthy males, with consistent safety and tolerability across all doses.

Both males and females demonstrated similar pharmacokinetic profiles for montelukast sodium, with oral bioavailability averaging around 66% for males and 58% for females, indicating effective absorption regardless of gender.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, bioavailability, and safety of montelukast sodium (MK-0476) in healthy males and females. Cheng, H., Leff, JA., Amin, R., et al.[2022]

In a study of 120 children aged 2-6 with otitis media with effusion (OME), the combination of montelukast and levocetirizine significantly improved clinical signs of middle ear fluid compared to other treatment groups.

While the combination therapy showed greater improvement in tympanometric findings, the difference was not statistically significant, indicating that while effective, further research may be needed to confirm the extent of its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of combination of montelukast and levocetirizine on otitis media with effusion: a prospective, placebo-controlled trial. Ertugay, CK., Cingi, C., Yaz, A., et al.[2021]

In a study involving 506 children aged 2 to 18 with mild to moderate persistent asthma, montelukast (Singulair) significantly improved asthma symptoms and treatment compliance over a 6-week period.

The treatment was well-received by both pediatricians and parents, indicating high satisfaction with montelukast as an effective monotherapy for managing childhood asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-life effectiveness of Singulair (montelukast) in 506 children with mild to moderate asthma. Amirav, I.[2021]

Citations

1. withpower.com withpower.com/trial/phase-4-rhinitis-2-2021-44c2a

Montelukast for Meniere's Disease · Info for Participants After one month of treatment, only 15.8% of patients taking montelukast and 21.1% of those on placebo experienced clearance of effusion, leading to the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04815187?term=AREA%5BConditionSearch%5D(Rhinitis)%20AND%20AREA%5BOverallStatus%5D(ACTIVE_NOT_RECRUITING)&rank=10

Study Details | Repurposed Use of Allergic Rhinitis and ... The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0013935123017760

Meniere's disease: Pathogenesis, treatments, and ... Overall, gentamicin has shown effectiveness in treating debilitating vertigo attacks and vestibular dysfunction in patients with intractable MD.

4. hifla.org hifla.org/research/menieres-disease-drug-trial/

Meniere's Disease Drug Trial This is a double-blind, placebo-controlled randomized study aimed at proof of concept that montelukast, a previously FDA-approved medication that is known to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4549154/

The Link Between Allergy and Menière's Disease - PMC In human subjects, further data supports a heightened allergic response in patients with Menière's disease while pharmacological treatments that ...