Lamotrigine and Bupropion for Meniere's Disease
Purpose
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.
Conditions
- Meniere Disease
- Ménière's Vertigo
- Vertigo, Intermittent
- Vertigo, Aural
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Subjects randomized to receive lamotrigine and bupropion or matching placebo randomized 1:1
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Double-Blind
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Lamotrigine and Bupropion |
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 Comparator Placebo |
The placebo will match the lamotrigine and bupropion dosage, frequency, and duration. |
|
Recruiting Locations
Dent Neurologic Institute
Amherst, New York 14226
Amherst, New York 14226
More Details
- NCT ID
- NCT05420350
- Status
- Unknown status
- Sponsor
- Dent Neuroscience Research Center
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.