Overview

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