Lamotrigine and Bupropion for Meniere's Disease

Meniere Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05420350
• Other study ID #: DBTC-003
• Status: Recruiting
• Phase: Phase 2
• Start date: December 16, 2020
• Est. completion date: December 2024

Study information

• Verified date: June 2022
• Source: Dent Neuroscience Research Center
• Contact: Maxwell Kahn, JD
• Phone: 716-250-7002
• Email: mkahn[@]dentinstitute.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dizziness
• Meniere Disease
• Ménière's Vertigo
• Vertigo
• Vertigo, Aural
• Vertigo, Intermittent

Intervention

Drug:
• Lamotrigine and Bupropion
Lamotrigine-oral pill taken once or twice a day with varying dosage per study timeline Bupropion-oral pill 100mg taken twice a day
• Placebo
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

Locations

Country	Name	City	State
United States	Dent Neurologic Institute	Amherst	New York

Sponsors (3)

Lead Sponsor	Collaborator
Dent Neuroscience Research Center	Cures Within Reach, Dent Family Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Primary	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
Primary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)