What is the mechanism of action of this treatment?

Ménière's Disease treatments primarily target fluid imbalance, inflammation, and abnormal nerve signaling in the inner ear. Diuretics reduce fluid retention, corticosteroids decrease inflammation, and betahistine improves blood flow. Vestibular suppressants like meclizine and anti-nausea medications manage vertigo. These mechanisms are essential for patients to understand as they explain how treatments alleviate symptoms and enhance quality of life.

What side effects are associated with this type of intervention?

Common treatments for Ménière's Disease include diuretics, vestibular suppressants, and anti-nausea medications. Diuretics can cause dehydration and electrolyte imbalances. Vestibular suppressants like meclizine and diazepam may lead to drowsiness, fatigue, and impaired coordination. Anti-nausea medications such as promethazine can cause drowsiness and dry mouth. Novel medications targeting the pathophysiological processes of Ménière's Disease, while promising, may also have side effects such as gastrointestinal disturbances, dizziness, and potential interactions with other medications. It is essential to discuss these with a healthcare provider to tailor the treatment to individual needs and monitor for adverse effects.

What prior FDA approvals exist?

There are currently no FDA-approved medications specifically for the treatment of Ménière's Disease. The novel medications being studied aim to target the pathophysiological processes of the disease, addressing symptoms such as vertigo, hearing loss, tinnitus, and aural pressure. These investigational treatments are being evaluated for their potential to improve the quality of life for patients with Ménière's Disease.

What other types of research exist?

Promising novel alternatives for Ménière's Disease patients in 2024 include: 1) Gene therapy, which aims to correct genetic defects associated with inner ear disorders. 2) Stem cell therapy, which focuses on regenerating damaged inner ear cells. 3) Cochlear implants, which can help manage hearing loss associated with Ménière's Disease. 4) Repetitive transcranial magnetic stimulation (rTMS), which has shown potential in managing tinnitus and vertigo symptoms. These alternatives are based on recent advancements and ongoing clinical trials.

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Tricyclic Antidepressant + Anticonvulsant

Nortriptyline + Topiramate for Meniere's Disease

Phase 4

Recruiting

Led By Hamid Djalilian, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing two different sets of medications to see which works better for treating Meniere's disease. One set calms nerves and stabilizes mood, while the other reduces fluid buildup. The goal is to find an effective treatment for patients suffering from severe symptoms like vertigo and hearing loss.

Who is the study for?

This trial is for adults aged 25-85 with active or frequent Meniere's Disease who can take medication regularly and attend study visits. They must be able to read and write English to consent. Excluded are pregnant women, those with a history of surgery for Meniere's, adverse reactions to the study medications, concerning medical conditions, psychosis, neurological tumors, or contraindications preventing safe use of the drugs.

What is being tested?

The trial tests if migraine medications nortriptyline and topiramate can treat Meniere's Disease symptoms like vertigo and hearing loss. There are no FDA-approved treatments for this condition yet; these drugs have shown promise in clinical practice.

What are the potential side effects?

Potential side effects from nortriptyline may include dry mouth, drowsiness, dizziness while topiramate might cause weight loss, tingling sensations in limbs or face fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Meniere Disease

Secondary study objectives

Dizziness

Meniere Disease

Patient Health Questionnaire (PHQ)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

Drug Has Already Been Approved

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: nortriptyline + topiramateExperimental Treatment1 Intervention

Nortriptyline (starting dose 7.5 mg) plus Topiramate (starting dose 10 mg) with appropriate dosage increase as necessary

Group II: hydrochlorothiazide + triamterene + placeboActive Control1 Intervention

hydrochlorothiazide (starting dose 25 mg) plus triamterene (starting dose 37.5 mg) with placebo being added in case of a dosage increase

Do I qualify?Apply below to find out

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

Ménière's Disease treatments primarily target fluid imbalance, inflammation, and abnormal nerve signaling in the inner ear. Diuretics reduce fluid retention, corticosteroids decrease inflammation, and betahistine improves blood flow. Vestibular suppressants like meclizine and anti-nausea medications manage vertigo. These mechanisms are essential for patients to understand as they explain how treatments alleviate symptoms and enhance quality of life.