Lamotrigine and Bupropion for Meniere's Disease

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dent Neuroscience Research Center
• Collaborators: Cures Within Reach; Dent Family Foundation
• Treatments: Bupropion; Lamotrigine

Criteria

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