Meniere DiseasePhase 2NCT05420350
Lamotrigine and Bupropion for Meniere's Disease
A Phase 2 study testing Lamotrigine and Bupropion in people with Meniere Disease and Ménière's Vertigo, run by Dent Neuroscience Research Center at 1 site in United States.
Trial summary
This is a double-blind, placebo-controlled clinical trial to assess whether treatment with lamotrigine and bupropion is more effective than placebo to reduce definitive Meniere's vertigo attacks (DMVA) and dizziness in patients with Meniere's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniere Disease, Ménière's Vertigo, Vertigo, Intermittent
- What is being tested?
- Lamotrigine and Bupropion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2020to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants, male and female aged 18 years or older
- Diagnosis of definitive unilateral Meniere's disease according to the AAO-HNS 1995 criteria, confirmed by an ENT or qualified medical professional
- Be experiencing active vertigo
- Be in good general health as evidenced by medical history or, otherwise, have all other co-existing medical or psychiatric conditions stable, and or no greater than moderate in severity, as determined by the PI
- Females of childbearing potential must use at least two forms of acceptable contraception, or remain abstinent; male participants must be willing to use condoms or other methods to ensure effective contraception with a partner
- Be willing to comply with all study procedures and availability for the duration of the study
- Be able to provide informed written consent, including agreement to privacy language either within the informed consent or in ancillary documents compliant with Health Insurance Portability and Accountability Act (HIPAA) before the initiation of any study-related procedures
Who cannot join
- A diagnosis of bilateral Meniere's disease according to the AAO-HNS 1995 criteria, confirmed by an ENT or qualified medical professional
- Be pregnant or lactating
- Have active migraine-associated vertigo
- Not be able to accurately identify and report episodes of vertigo
- Diagnosis of any other neuro-otologic disease or major vestibular abnormality found during screening that could confound the evaluation of Meniere's symptoms
- Have a history of intolerance or sensitivity to lamotrigine
Show all 12Show fewer
- Previously failed the study drug
- Received an intratympanic gentamicin injection(s) or endolymphatic sac surgery within in the last year
- Have a family history of unexplained deafness
- Have any current diseases or conditions that may be associated with an altered perception of processing stimuli
- Have a history of substance abuse within the preceding 6 months prior to screening
- Have non-vertiginous dizziness (orthostatic or panic disorder) unless it could be clearly differentiated from Meniere's attacks by the participant
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dent Neurologic Institute
Amherst, New York, 14226
Maxwell Kahn, JD, 716-250-7002, mkahn@dentinstitute.com
Dawn Pytlik, AAS, 716-250-3083, dpytlik@dentinstitute.com
About this study
Official title: A Randomized, Prospective, Double-Blind, Placebo-Controlled, Pilot Study to Assess the Effectiveness of a Combination of Lamotrigine and Bupropion to Treat 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 reduce definitive Meniere's vertigo attacks (DMVA) and dizziness in patients with Meniere's disease. Thirty four participants will be randomized to treatment or placebo groups. Each participant will take part in the trial for 34 weeks, or approximately 9 months.
Read the detailed description
Participants begin with a 4 week lead-in after screening to determine the frequency and severity of vertigo they are experiencing. Participants continue to track their vertigo episodes throughout the study. At Visit 2, if eligible, participants begin the titration of lamotrigine or matching placebo. 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 placebo for 12 weeks. At Week 27, participants are tapered off lamotrigine/placebo and stop taking bupropion/placebo. Participants have an in-person visit approximately once a month over 9 months.
- Being tested
- Lamotrigine and Bupropion, Placebo
- Keywords
- Lamictal, Lamotrigine, Anticonvulsant, Meniere's Disease, Vertigo attack, Dizziness, Vestibular disorder, Wellbutrin, Bupropion
- Medical subject headings
- Meniere Disease, Vertigo, Dizziness, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamotrigine and BupropionDrug
Also called Lamictal, Lamictal ODT, Lamictal XR, Wellbutrin XL
Lamotrigine-oral pill taken once or twice a day with varying dosage per study timeline Bupropion-oral pill 100mg taken twice a day
PlaceboDrug
Also called Microcrystalline cellulose
Oral pill matched with lamotrigine to be taken once or twice a day per study timeline Oral pill matched with bupropion to be taken twice a day
| Study group | Role | What they receive |
|---|---|---|
| Lamotrigine and Bupropion | Active comparator | 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. Receives: Drug: Lamotrigine and Bupropion |
| Placebo | Placebo comparator | The placebo will match the lamotrigine and bupropion dosage, frequency, and duration. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ménière's vertigo attack frequency between groups
Number of Definitive Ménière's Vertigo attacks (DMVA), Number of Dizziness Days and overall dizziness severity during each 4-week of titration, and treatment compared to the 4-week lead-in phase. Vertigo ratings will be collected on a daily symptom diary throughout the study. DMVA is defined as vertigo for more than 20 minutes and corresponds to a vertigo rating of 3 or 4 on the daily symptom diary. A Dizziness Day is defined as vertigo rating of 1, 2, 3 or 4 on the daily symptom diary. Dizziness severity is the sum of all ratings (0-4) during each 4-week period.
Measured: Duration of lead-in to completion at week 30
Change in Ménière's vertigo attack frequency lamotrigine alone compared to lamotrigine and bupropion
Number of Definitive Ménière's Vertigo attacks (DMVA), Number of Dizziness Days and overall dizziness severity during each 4-week of treatment of lamotrigine alone and treatment of bupropion and lamotrigine.Vertigo ratings will be collected on a daily symptom diary throughout the study. DMVA is defined as vertigo for more than 20 minutes and corresponds to a vertigo rating of 3 or 4 on the daily symptom diary. A Dizziness Day is defined as vertigo rating of 1, 2, 3 or 4 on the daily symptom diary. Dizziness severity is the sum of all ratings (0-4) during each 4-week period.
Measured: Week 1 to Week 27
Secondary outcomes (5)
Changes in patients' self-assessment of dizziness
Between groups comparisons of Dizziness Handicap Inventory (DHI) at Week 27 compared to the baseline visit at the end of the lead-in phase. DHI at baseline compared to evaluation at end of treatment.
Scores range from 0-100 with higher scores meaning more severe dizziness handicap
Measured: Baseline (Week 1) and Visit 8 (Week 27)
Changes in patients' self-assessment of overall affect of symptoms
Between groups comparisons of Ménière's Disease Patient-Oriented Symptom-Severity Index (MDPOSI) at Week 27 compared to the baseline visit at the end of the lead-in phase. MDPOSI at baseline compared to evaluation at end of treatment.
Scores range from 0-80 with higher numbers indicating more frequent and severe symptoms.
Measured: Baseline (Week 1) and Visit 8 (Week 27)
Changes in patients' self-assessment of symptom impact on daily life function
Between groups comparisons of Ménière's Disease Self-Assessment (MDSA) at Week 27 compared to the baseline visit at the end of the lead-in phase. MDSA at baseline compared to evaluation at end of treatment.
Scores range from 1-6 with higher numbers representing Ménière's Disease symptoms having a greater affect on the patient's ability to function in daily life.
Measured: Baseline (Week 1) and Visit 8 (Week 27)
Changes in patients' self-assessment of depression
Between groups comparisons of Patient Health Questionnaire-9 (PHQ-9) at Week 27 compared to the baseline visit at the end of the lead-in phase. PHQ-9 at baseline compared to evaluation at end of treatment.
Scores range from 0-27 with higher numbers meaning more severe depression.
Measured: Baseline (Week 1) and Visit 8 (Week 27)
Changes in patients' self-assessment of anxiety
Between groups comparisons of General Anxiety Disorder-7 (GAD-7) at Week 27 compared to the baseline visit at the end of the lead-in phase. GAD-7 at baseline compared to evaluation at end of treatment.
Scores range from 0-21 with higher numbers meaning more severe anxiety.
Measured: Baseline (Week 1) and Visit 8 (Week 27)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start16 Dec 2020
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniere DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects randomized to receive lamotrigine and bupropion or matching placebo randomized 1:1
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dent Neuroscience Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cures Within Reach, Dent Family Foundation
- Responsible party
- Principal investigator, Lixin Zhang, Dent Neuroscience Research Center
- Investigators
- Lixin Zhang, MD, PhD, Principal investigator, Dent Neurologic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420350
- Sponsor's protocol ID
- DBTC-003
- Status last verified
- Jun 2022
- First submitted
- 26 May 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Double-Blind, Placebo-Controlled, Pilot Study to Assess the Effectiveness of a Combination of Lamotrigine and Bupropion to Treat Meniere's Disease
- ClinicalTrials.gov ID
- NCT05420350
- Acronym / sponsor ID
- DBTC-003
- Keywords
- Lamictal, Lamotrigine, Anticonvulsant, Meniere's Disease, Vertigo attack, Dizziness, Vestibular disorder, Wellbutrin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Dent Neuroscience Research CenterUniversity, hospital or other
- Collaborators
- Cures Within Reach, Dent Family Foundation
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, placebo-controlled clinical trial to assess whether treatment with lamotrigine and bupropion is more effective than placebo to reduce definitive Meniere's vertigo attacks (DMVA) and dizziness in patients with Meniere's disease. Thirty four participants will be randomized to treatment or placebo groups. Each participant will take part in the trial for 34 weeks, or approximately 9 months.
Detailed description
Participants begin with a 4 week lead-in after screening to determine the frequency and severity of vertigo they are experiencing. Participants continue to track their vertigo episodes throughout the study. At Visit 2, if eligible, participants begin the titration of lamotrigine or matching placebo. 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 placebo for 12 weeks. At Week 27, participants are tapered off lamotrigine/placebo and stop taking bupropion/placebo. Participants have an in-person visit approximately once a month over 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects randomized to receive lamotrigine and bupropion or matching placebo randomized 1:1
| Arm | Type | Receives |
|---|---|---|
| Lamotrigine and Bupropion | Active comparator | Drug: Lamotrigine and BupropionLamotrigine 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. |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo will match the lamotrigine and bupropion dosage, frequency, and duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult participants, male and female aged 18 years or older
- Diagnosis of definitive unilateral Meniere's disease according to the AAO-HNS 1995 criteria, confirmed by an ENT or qualified medical professional
- Be experiencing active vertigo
- Be in good general health as evidenced by medical history or, otherwise, have all other co-existing medical or psychiatric conditions stable, and or no greater than moderate in severity, as determined by the PI
- Females of childbearing potential must use at least two forms of acceptable contraception, or remain abstinent; male participants must be willing to use condoms or other methods to ensure effective contraception with a partner
Key exclusion criteria (12 listed)
- A diagnosis of bilateral Meniere's disease according to the AAO-HNS 1995 criteria, confirmed by an ENT or qualified medical professional
- Be pregnant or lactating
- Have active migraine-associated vertigo
- Not be able to accurately identify and report episodes of vertigo
- Diagnosis of any other neuro-otologic disease or major vestibular abnormality found during screening that could confound the evaluation of Meniere's symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lamotrigine and BupropionAlso: Lamictal, Lamictal ODT, Lamictal XR, Wellbutrin XLLamotrigine-oral pill taken once or twice a day with varying dosage per study timeline Bupropion-oral pill 100mg taken twice a day | Drug | Lamotrigine and Bupropion |
| PlaceboAlso: Microcrystalline celluloseOral pill matched with lamotrigine to be taken once or twice a day per study timeline Oral pill matched with bupropion to be taken twice a day | Drug | Placebo |
Primary outcome
Change in Ménière's vertigo attack frequency between groups
Time frame: Duration of lead-in to completion at week 30
Number of Definitive Ménière's Vertigo attacks (DMVA), Number of Dizziness Days and overall dizziness severity during each 4-week of titration, and treatment compared to the 4-week lead-in phase. Vertigo ratings will be collected on a daily symptom diary throughout the study. DMVA is defined as vertigo for more than 20 minutes and corresponds to a vertigo rating of 3 or 4 on the daily symptom diary. A Dizziness Day is defined as vertigo rating of 1, 2, 3 or 4 on the daily symptom diary. Dizziness severity is the sum of all ratings (0-4) during each 4-week period.
Change in Ménière's vertigo attack frequency lamotrigine alone compared to lamotrigine and bupropion
Time frame: Week 1 to Week 27
Number of Definitive Ménière's Vertigo attacks (DMVA), Number of Dizziness Days and overall dizziness severity during each 4-week of treatment of lamotrigine alone and treatment of bupropion and lamotrigine.Vertigo ratings will be collected on a daily symptom diary throughout the study. DMVA is defined as vertigo for more than 20 minutes and corresponds to a vertigo rating of 3 or 4 on the daily symptom diary. A Dizziness Day is defined as vertigo rating of 1, 2, 3 or 4 on the daily symptom diary. Dizziness severity is the sum of all ratings (0-4) during each 4-week period.
5 secondary outcomes
Changes in patients' self-assessment of dizziness
Time frame: Baseline (Week 1) and Visit 8 (Week 27)
Changes in patients' self-assessment of overall affect of symptoms
Time frame: Baseline (Week 1) and Visit 8 (Week 27)
Changes in patients' self-assessment of symptom impact on daily life function
Time frame: Baseline (Week 1) and Visit 8 (Week 27)
Changes in patients' self-assessment of depression
Time frame: Baseline (Week 1) and Visit 8 (Week 27)
Changes in patients' self-assessment of anxiety
Time frame: Baseline (Week 1) and Visit 8 (Week 27)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lixin Zhang, MD, PhD principal investigator
Dent Neurologic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lamotrigine and Bupropion in people with Meniere Disease and Ménière's Vertigo, run by Dent Neuroscience Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maxwell Kahn, JD (716-250-7002, mkahn@dentinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ménière's vertigo attack frequency between groups (time frame: Duration of lead-in to completion at week 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.