Status:
UNKNOWN
Lamotrigine and Bupropion for Meniere's Disease
Lead Sponsor:
Dent Neuroscience Research Center
Collaborating Sponsors:
Cures Within Reach
Dent Family Foundation
Conditions:
Meniere Disease
Ménière's Vertigo
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05420350
Start Date
December 16 2020
End Date
December 1 2024
Last Update
June 21 2022
Active Locations (1)
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1
Dent Neurologic Institute
Amherst, New York, United States, 14226