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

34 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 the combination of Lamotrigine and Bupropion safe for humans?

Lamotrigine has been studied for safety in various conditions, showing it is generally well tolerated, though some people may experience side effects like dizziness, headache, or skin rash. Bupropion is not mentioned in the provided research, so specific safety data for the combination with Lamotrigine is not available. ^{1 2 3 4 5}

How does the drug combination of Lamotrigine and Bupropion for Meniere's Disease differ from other treatments?

This treatment is unique because it combines Lamotrigine, a drug known for treating epilepsy and mood disorders, with Bupropion, an antidepressant, to address Meniere's Disease, a condition with no standard treatment. This novel approach leverages the individual benefits of these drugs, potentially offering a new way to manage symptoms. ^{1 2 5 6 7}

Research Team

Lixin Zhang, MD, PhD

Principal Investigator

Dent Neurologic Institute

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of lamotrigine in pediatric mood disorders: A systematic review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Human safety of lamotrigine. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A placebo-controlled trial of lamotrigine add-on therapy for partial seizures in children. Lamictal Pediatric Partial Seizure Study Group. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Lamotrigine and its applications in the treatment of epilepsy and other neurological and psychiatric disorders. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

A pooled analysis of 2 placebo-controlled 18-month trials of lamotrigine and lithium maintenance in bipolar I disorder. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Lamotrigine in the treatment of bipolar disorder. [2019]