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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
Awards & highlights
Study Summary
This trial will test whether two drugs are more effective than a placebo at reducing vertigo attacks and dizziness in patients with Meniere's disease. 34 people will be divided into groups, and each group will take the trial drug or placebo for 34 weeks.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I have never taken Lamotrigine.
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I have been diagnosed with Meniere's Disease.
Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Ménière's vertigo attack frequency between groups
Change in Ménière's vertigo attack frequency lamotrigine alone compared to lamotrigine and bupropion
Secondary outcome measures
Changes in patients' self-assessment of anxiety
Changes in patients' self-assessment of depression
Changes in patients' self-assessment of dizziness
+2 moreOther outcome measures
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.
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Cures Within ReachOTHER
19 Previous Clinical Trials
1,709 Total Patients Enrolled
1 Trials studying Vertigo
40 Patients Enrolled for Vertigo
Dent Neuroscience Research CenterLead Sponsor
5 Previous Clinical Trials
80 Total Patients Enrolled
1 Trials studying Vertigo
15 Patients Enrolled for Vertigo
Dent Family FoundationUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have been diagnosed with Meniere's disease by a specialist.I experience more than two Meniere's attacks monthly, each lasting over 20 minutes.I am using two forms of birth control or practicing abstinence.I am 18 years old or older.You agree to follow all the study rules and be available for the entire study period.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.I have never taken Lamotrigine.You understand and agree to the rules of the study, and you will sign a paper saying so.I am currently experiencing dizziness.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Lamotrigine and Bupropion
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 4 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 7 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 8 Months after you stop receiving the treatment.
Vertigo Patient Testimony for trial: Trial Name: NCT05420350 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are currently signed up for this research project?
"That is correct. The online clinicaltrials.gov registry shows that the trial, which was created on December 16th 2020, is still recruiting patients. They need a total of 34 individuals from 1 location to complete the study."
Answered by AI
What are the desired outcomes of this research project?
"The aim of this study, which will be conducted over a period of 30 weeks, is to compare the effectiveness of lamotrigine alone versus lamotrigine and bupropion in reducing Ménière's disease-related vertigo attacks. Secondary outcome measures include changes in self-reported depression (assessed using the Patient Health Questionnaire-9), dizziness (assessed using the Dizziness Handicap Inventory), and anxiety (assessed using the General Anxiety Disorder-7) scores."
Answered by AI
Are there any available slots left for this clinical trial?
"The listing on clinicaltrials.gov verifies that this study is still searching for participants. This trial was first posted on December 16th, 2020 and the most recent update occurred on June 17th, 2022. Currently, only 34 patients are needed from a single site."
Answered by AI
What are the FDA's thoughts on Lamotrigine and Bupropion?
"As this is a Phase 2 trial, meaning that while there is some data supporting safety, none supporting efficacy, our team at Power has scored Lamotrigine and Bupropion's safety at a 2."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
California
Other
New York
How old are they?
65+
18 - 65
What site did they apply to?
Dent Neurologic Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
What questions have other patients asked about this trial?
What is the time commitment? When would I know if I have been selected?
PatientReceived no prior treatments
Why did patients apply to this trial?
I want to contribute to finding a treatment for vertigo/dizziness. Eu quero contribuir para a descoberta da origem e como tratar essa doenca maligna.
PatientReceived no prior treatments
I have have full vertigo for 2 years and very diabling in my everday life and I seek help.
PatientReceived 1 prior treatment
I have had dizzy spells for quite a few years now and why has not been found. They are very scary because I live alone and I am a very active person.
PatientReceived 1 prior treatment
I suffer from dizzy and balance issues I have taken every antibiotic known to man and have seen a number of ent specialist I also have had 2 nose operations nothing helps so I signed up for the trial to see if I am eligible to get into this trial to see if this helps.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Average response time
- < 1 Day
Most responsive sites:
- Dent Neurologic Institute: < 24 hours
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