Back to resultsLamotrigine and Bupropion for Meniere's Disease
Primary Purpose
Meniere Disease, Ménière's Vertigo, Vertigo, Intermittent
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lamotrigine and Bupropion
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Meniere Disease focused on measuring Lamictal, Lamotrigine, Anticonvulsant, Meniere's Disease, Vertigo attack, Dizziness, Vestibular disorder, Wellbutrin, Bupropion
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Dent Neurologic InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lamotrigine and Bupropion
Placebo
Arm Description
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.
The placebo will match the lamotrigine and bupropion dosage, frequency, and duration.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
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.
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.
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.
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.
Full Information
NCT ID
NCT05420350
First Posted
May 26, 2022
Last Updated
June 17, 2022
Sponsor
Dent Neuroscience Research Center
Collaborators
Cures Within Reach, Dent Family Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05420350
Brief Title
Lamotrigine and Bupropion for Meniere's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dent Neuroscience Research Center
Collaborators
Cures Within Reach, Dent Family Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere Disease, Ménière's Vertigo, Vertigo, Intermittent, Vertigo, Aural
Keywords
Lamictal, Lamotrigine, Anticonvulsant, Meniere's Disease, Vertigo attack, Dizziness, Vestibular disorder, Wellbutrin, Bupropion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Subjects randomized to receive lamotrigine and bupropion or matching placebo randomized 1:1
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-Blind
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lamotrigine and Bupropion
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo will match the lamotrigine and bupropion dosage, frequency, and duration.
Intervention Type
Drug
Intervention Name(s)
Lamotrigine and Bupropion
Other Intervention Name(s)
Lamictal, Lamictal ODT, Lamictal XR, Wellbutrin XL, Wellbutrin SR, Forfivo XL
Intervention Description
Lamotrigine-oral pill taken once or twice a day with varying dosage per study timeline Bupropion-oral pill 100mg taken twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Microcrystalline cellulose
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Ménière's vertigo attack frequency between groups
Description
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.
Time Frame
Duration of lead-in to completion at week 30
Title
Change in Ménière's vertigo attack frequency lamotrigine alone compared to lamotrigine and bupropion
Description
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.
Time Frame
Week 1 to Week 27
Secondary Outcome Measure Information:
Title
Changes in patients' self-assessment of dizziness
Description
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
Time Frame
Baseline (Week 1) and Visit 8 (Week 27)
Title
Changes in patients' self-assessment of overall affect of symptoms
Description
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.
Time Frame
Baseline (Week 1) and Visit 8 (Week 27)
Title
Changes in patients' self-assessment of symptom impact on daily life function
Description
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.
Time Frame
Baseline (Week 1) and Visit 8 (Week 27)
Title
Changes in patients' self-assessment of depression
Description
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.
Time Frame
Baseline (Week 1) and Visit 8 (Week 27)
Title
Changes in patients' self-assessment of anxiety
Description
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.
Time Frame
Baseline (Week 1) and Visit 8 (Week 27)
Other Pre-specified Outcome Measures:
Title
Change in patients' tinnitus from baseline to the end of treatment.
Description
Between groups comparisons of Tinnitus Handicap Index (THI) at Week 27 compared to the baseline visit at the end of the lead-in phase. THI at baseline compared to evaluation at end of treatment.
Score range from 0-100 with higher numbers representing a more severe tinnitus handicap.
Time Frame
Baseline (Week 1) and Visit 8 (Week 27)
Title
Change in patients' hearing loss from baseline to the end of treatment.
Description
Between groups comparisons of hearing loss at Week 24 compared to the baseline visit at the end of the lead-in phase. Hearing loss measured based off the pure-tone average at 500 Hz, 1000 Hz, 2000 Hz, and 3000 Hz measured in dB from audiometric report taken at Visit 1 and Visit 8.
Time Frame
Baseline (Week 1) and Visit 8 (Week 27)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maxwell Kahn, JD
Phone
716-250-7002
Email
mkahn@dentinstitute.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dawn Pytlik
Phone
716-250-3083
Email
dpytlik@dentinstitute.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lixin Zhang, MD, PhD
Organizational Affiliation
Dent Neurologic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dent Neurologic Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxwell Kahn, JD
Phone
716-250-7002
Email
mkahn@dentinstitute.com
First Name & Middle Initial & Last Name & Degree
Dawn Pytlik, AAS
Phone
716-250-3083
Email
dpytlik@dentinstitute.com
First Name & Middle Initial & Last Name & Degree
Lixin Zhang, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Lamotrigine and Bupropion for Meniere's Disease
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