What side effects are associated with this type of intervention?

Common treatments for vertigo include medications like Lamotrigine and Bupropion. Lamotrigine, which stabilizes neuronal membranes by inhibiting sodium channels, can cause side effects such as dizziness, headache, double vision, and rash. Bupropion, which inhibits the reuptake of norepinephrine and dopamine, may lead to side effects including insomnia, dry mouth, headache, and increased risk of seizures. Both medications require careful monitoring to manage these potential adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for vertigo primarily include medications that address the underlying causes, such as vestibular suppressants (e.g., meclizine, dimenhydrinate) and antiemetics (e.g., promethazine). While Lamotrigine and Bupropion are being studied for their potential benefits in treating vertigo due to their unique mechanisms of action, they are not currently FDA-approved for this indication. Lamotrigine stabilizes neuronal membranes by inhibiting sodium channels, and Bupropion inhibits the reuptake of norepinephrine and dopamine, which may offer new therapeutic avenues for vertigo management if proven effective.

What other types of research exist?

Promising novel alternatives to Lamotrigine and Bupropion for vertigo patients include Botulinum Toxin Type A, which has shown efficacy in treating chronic migraine and could potentially benefit vertigo patients, and Pregabalin, which has been used in the treatment of chronic migraine and may offer relief for vertigo symptoms. Additionally, Memantine, used for refractory migraine, could be considered for its neuroprotective properties.

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Anticonvulsant and Antidepressant

Lamotrigine and Bupropion for Meniere's Disease

Phase 2

Recruiting

Led By Lixin Zhang, MD, PhD

Research Sponsored by Dent Neuroscience Research Center

Eligibility Criteria Checklist

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

Must have

Adult participants, male and female aged 18 years or older

Be experiencing active vertigo

Timeline

Screening 4 weeks

Treatment 7 months

Follow Up 8 months

Summary

This trial tests if lamotrigine and bupropion can reduce vertigo attacks and dizziness in patients with Meniere's disease. These medications balance brain chemicals to help manage these symptoms. Lamotrigine is commonly used to prevent depressive relapses in bipolar disorder, while bupropion is an antidepressant with some evidence supporting its use in bipolar depression.

Who is the study for?

Adults with definitive unilateral Meniere's disease experiencing active vertigo and at least two attacks per month are eligible for this trial. Participants must be in good health or have stable conditions, agree to use effective contraception, provide informed consent, and commit to the study duration.

What is being tested?

The trial is testing if Lamotrigine and Bupropion reduce vertigo attacks better than a placebo in Meniere's disease patients. It's a double-blind study where participants won't know if they're getting the real treatment or a placebo for about 9 months.

What are the potential side effects?

Potential side effects of Lamotrigine may include skin rashes, dizziness, headaches, blurred vision, nausea; while Bupropion can cause insomnia, dry mouth, headache, nausea. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am currently experiencing dizziness.

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I have never taken Lamotrigine.

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I have been diagnosed with Meniere's Disease.

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I experience more than two Meniere's attacks monthly, each lasting over 20 minutes.

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I have never taken Lamotrigine.

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I have been diagnosed with Meniere's Disease.

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I experience more than two Meniere's attacks monthly, each lasting over 20 minutes.

Timeline

Screening ~ 4 weeks1 visit

Treatment ~ 7 months7 visits

Follow Up ~ 8 months9 visits

Screening ~ 4 weeks

Treatment ~ 7 months

Follow Up ~8 months

This trial's timeline: 4 weeks for screening, 7 months for treatment, and 8 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Ménière's vertigo attack frequency between groups

Change in Ménière's vertigo attack frequency lamotrigine alone compared to lamotrigine and bupropion

Secondary study objectives

Changes in patients' self-assessment of anxiety

Changes in patients' self-assessment of depression

Changes in patients' self-assessment of dizziness

+2 more

Other study objectives

Change in patients' hearing loss from baseline to the end of treatment.

Change in patients' tinnitus from baseline to the end of treatment.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Lamotrigine and BupropionActive Control1 Intervention

Lamotrigine will be taken orally for a duration of 28 weeks, consisting of a six-week titration, 20-week study period, and two-week taper. Possible doses are 25mg one a day, 50mg once a day, 50mg twice a day, 75mg twice a day during titration; 125mg twice a day for the study period; and 125mg once a day during the two-week taper. Patients who discontinue at any point of the study will have a two-week taper of lamotrigine. Bupropion will be taken orally for the duration of 20 week at the dosage of 100mg twice a day.

Group II: PlaceboPlacebo Group1 Intervention

The placebo will match the lamotrigine and bupropion dosage, frequency, and duration.

0 / 8Eligibility 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

Lamotrigine stabilizes neuronal membranes by inhibiting sodium channels, reducing excessive neuronal firing that can contribute to vertigo symptoms. Bupropion inhibits the reuptake of norepinephrine and dopamine, increasing their levels in the brain, which can help improve mood and reduce dizziness. These mechanisms are important for vertigo patients as they target different pathways involved in the condition, offering a multifaceted approach to symptom management.

Effect of drug therapy on compensation from vestibular injury.Effectiveness of trihexyphenidyl against pendular nystagmus and palatal myoclonus: evidence of cholinergic dysfunction.Vestibular compensation in aged rats with unilateral labyrinthectomy treated with dopaminergic drugs.