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| Name | Class |
|---|---|
| Cures Within Reach | OTHER |
| Dent Family Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | The placebo will match the lamotrigine and bupropion dosage, frequency, and duration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamotrigine and Bupropion | Drug | Lamotrigine-oral pill taken once or twice a day with varying dosage per study timeline Bupropion-oral pill 100mg taken twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Week 1 to Week 27 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (Week 1) and Visit 8 (Week 27) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Week 1) and Visit 8 (Week 27) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maxwell Kahn, JD | Contact | 716-250-7002 | mkahn@dentinstitute.com | |
| Dawn Pytlik | Contact | 716-250-3083 | dpytlik@dentinstitute.com |
| Name | Affiliation | Role |
|---|---|---|
| Lixin Zhang, MD, PhD | Dent Neurologic Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dent Neurologic Institute | Recruiting | Amherst | New York | 14226 | United States |
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| ID | Term |
|---|---|
| D008575 | Meniere Disease |
| D014717 | Vertigo |
| D004244 | Dizziness |
| D015837 | Vestibular Diseases |
| ID | Term |
|---|---|
| D018159 | Endolymphatic Hydrops |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000077213 | Lamotrigine |
| D016642 | Bupropion |
| C109691 | microcrystalline cellulose |
| ID | Term |
|---|---|
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011427 | Propiophenones |
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Subjects randomized to receive lamotrigine and bupropion or matching placebo randomized 1:1
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Double-Blind
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| Placebo | Drug | 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 |
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| 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. | 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. | 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. | 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. | 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. | Baseline (Week 1) and Visit 8 (Week 27) |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012678 | Sensation Disorders |
| D007659 |
| Ketones |
| D009930 | Organic Chemicals |