Lamotrigine and Bupropion for Meniere's Disease

Overseen By Jennifer Cox, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2

Sponsor: Dent Neuroscience Research Center

Disqualifiers: Bilateral Meniere's, Pregnancy, Migraines, others

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

Compensation: Varies

Number of Visits: 10

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining lamotrigine and bupropion can reduce dizziness and vertigo attacks in people with Meniere's disease, a disorder affecting the inner ear. Participants will receive either the active medications or a placebo (a pill with no active medicine) for about 9 months. It suits those diagnosed with Meniere's disease in one ear and currently experiencing vertigo episodes. The goal is to find an effective treatment to improve daily life for those struggling with this condition. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potential advancements in managing Meniere's disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lamotrigine is as safe as a placebo, a harmless pill used in studies. In four studies involving 92 patients, only two serious side effects occurred, indicating it is generally well-tolerated.

Bupropion has already received FDA approval for other uses, which can reassure about its safety. Most people tolerate it well, though some might experience side effects like dry mouth or trouble sleeping.

Overall, current evidence suggests that both lamotrigine and bupropion are generally safe. However, individual experiences can differ, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Meniere's disease?

Researchers are excited about using Lamotrigine and Bupropion for Meniere's Disease because these medications offer a novel approach compared to standard treatments like diuretics, antihistamines, and vestibular suppressants. Unlike traditional treatments that primarily focus on symptomatic relief, Lamotrigine works by stabilizing electrical activity in the brain and Bupropion acts as an antidepressant that can also help with chronic dizziness. This combination targets different neurological pathways, potentially providing a more comprehensive treatment for Meniere's Disease, addressing both the underlying issues and the resulting symptoms.

What evidence suggests that lamotrigine and bupropion might be an effective treatment for Meniere's disease?

Research shows that lamotrigine can reduce vertigo attacks by calming overactive brain cells. Studies also indicate that bupropion helps balance brain chemicals, potentially lessening dizziness. This trial tests the combination of lamotrigine and bupropion to determine if they can better manage symptoms of Meniere's disease. Although limited data exists on their combined use for Meniere's, their effects on the brain suggest promise. Participants in this trial may receive either the active combination of lamotrigine and bupropion or a placebo. ^{1 2 3 4 6}

Who Is on the Research Team?

Lixin Zhang, MD, PhD

Principal Investigator

Dent Neurologic Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You must be generally healthy or have stable medical/psychiatric conditions that are not severe. The Principal Investigator will determine if you meet this criteria.

I have been diagnosed with Meniere's disease by a specialist.

I am using two forms of birth control or practicing abstinence.

Exclusion Criteria

I have been diagnosed with Meniere's Disease.

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

I have never taken Lamotrigine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Lead-in

Participants begin with a 4-week lead-in to determine the frequency and severity of vertigo

4 weeks

1 visit (in-person)

Titration

Participants begin titration of lamotrigine or matching placebo

6 weeks

1 visit (in-person)

Treatment

Participants are on the full dose of lamotrigine/placebo and then take bupropion/placebo along with lamotrigine/placebo

20 weeks

5 visits (in-person)

Taper

Participants are tapered off lamotrigine/placebo and stop taking bupropion/placebo

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Lamotrigine and Bupropion
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Lamotrigine and Bupropion Active Control 1 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: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Dent Neuroscience Research Center

Lead Sponsor

Trials

6

Recruited

110+

Cures Within Reach

Collaborator

Trials

25

Recruited

2,100+

Dent Family Foundation

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

Lamotrigine (LTG) was found to have a similar safety profile to placebo in a pooled analysis of four double-blind trials involving 92 patients, with only two patients withdrawing due to adverse effects.

In a larger group of 572 patients from open studies, common side effects included dizziness and headache, but no significant clinical changes or serious adverse events were linked to LTG, indicating it is generally safe when added to existing antiepileptic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human safety of lamotrigine. Betts, T., Goodwin, G., Withers, RM., et al.[2019]

Lamotrigine is an effective and well-tolerated treatment for bipolar disorder, particularly beneficial for managing depressive symptoms during both acute and maintenance phases, as supported by various placebo-controlled studies involving different patient types.

Unlike traditional antidepressants, lamotrigine does not trigger manic episodes or increase cycling frequency, making it a preferred option for treating acute bipolar depression and preventing recurrent depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lamotrigine in the treatment of bipolar disorder. Bowden, CL.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05420350

Lamotrigine and Bupropion for Meniere's Disease This is a double-blind, placebo-controlled clinical trial to assess whether treatment with lamotrigine and bupropion is more effective than placebo to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05420350?cond=Meniere's%20Disease&sort=StudyFirstPostDate&rank=9&fbclid=IwY2xjawJh525leHRuA2FlbQIxMAABHpiLPWTlWa8AUekMqNc9Yzq6LnBSwAHMgnxrkC7JMXqedNf64PP1qRhQ7DlF_aem_Goa-UgAvXsi-NbsTp8K1Ug

Lamotrigine and Bupropion for Meniere's Disease An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

3. withpower.com withpower.com/trial/phase-2-mnires-vertigo-11-2020-813f7

Lamotrigine + Bupropion for Meniere's Disease This trial tests if lamotrigine and bupropion can reduce vertigo attacks and dizziness in patients with Meniere's disease. These medications balance brain ...

4. najms.com najms.com/index.php/najms/article/download/585/588/938

Lamotrigine Reduces the Number of Vertigo Attacks in ... 32 In addition to its efficacy to reduce seizures, lamotrigine has been shown to decrease hyperexcitability of neurons in the brain to treat ...

5. trialstoday.org trialstoday.org/trial/NCT05420350

Lamotrigine and Bupropion for Meniere's Disease This is a double-blind, placebo-controlled clinical trial to assess whether treatment with lamotrigine and bupropion is more effective than placebo.

6. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05420350?keyword=%22Lamotrigine%22

Lamotrigine and Bupropion for Meniere's Disease Participants are on the full dose of lamotrigine/placebo for 8 weeks, and then begin taking bupropion or matching placebo along with lamotrigine or matching ...