A Phase 2 interventional study of Lamotrigine and Bupropion and Placebo in Meniere Disease, Ménière's Vertigo and Vertigo, Intermittent, sponsored by Dent Neuroscience Research Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-21.
Sponsored by Dent Neuroscience Research Center · Phase 2, Interventional, and Treatment
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.
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.
248 studies on the registry are indexed under Vertigo; 39 are open to participants now.
This study's planned enrollment of 34 is below the median of 57 across 186 interventional studies indexed under Vertigo.
Browse Vertigo studies →Dent Neuroscience Research Center is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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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.
Drug: Lamotrigine and Bupropion
The placebo will match the lamotrigine and bupropion dosage, frequency, and duration.
Drug: Placebo
Lamotrigine-oral pill taken once or twice a day with varying dosage per study timeline Bupropion-oral pill 100mg taken twice a day
Also known as: Lamictal, Lamictal ODT, Lamictal XR, Wellbutrin XL, Wellbutrin SR, Forfivo XL
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
Also known as: Microcrystalline cellulose
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.
Time frame: 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.
Time frame: Week 1 to Week 27
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Week 1) and Visit 8 (Week 27)
Change in patients' tinnitus from baseline to the end of treatment.
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)
Change in patients' hearing loss from baseline to the end of treatment.
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)
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Dent Neuroscience Research Center