Lamotrigine and Bupropion for Meniere's Disease (NCT05420350) | Clinical Trial Compass
UnknownPhase 2
Lamotrigine and Bupropion for Meniere's Disease
United States34 participantsStarted 2020-12-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 …