Clinical trial NCT05420350: Lamotrigine and Bupropion for Meniere's Disease
Official title: A Randomized, Prospective, Double-Blind, Placebo-Controlled, Pilot Study to Assess the Effectiveness of a Combination of Lamotrigine and Bupropion to Treat Meniere's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Meniere Disease
Ménière's Vertigo
Vertigo, Intermittent
Vertigo, Aural
Keywords: Lamictal
Lamotrigine
Anticonvulsant
Meniere's Disease
Vertigo attack
Dizziness
Vestibular disorder
Wellbutrin
Bupropion
Lead sponsor: Dent Neuroscience Research Center
Sponsor class: OTHER
Collaborators: name: Cures Within Reach
name: Dent Family Foundation
First posted: 2022-06-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects randomized to receive lamotrigine and bupropion or matching placebo randomized 1:1
Primary purpose: TREATMENT

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) 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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Ménière's vertigo attack frequency between groups
timeFrame: Duration of lead-in to completion at week 30
measure: Change in Ménière's vertigo attack frequency lamotrigine alone compared to lamotrigine and bupropion
timeFrame: Week 1 to Week 27
Secondary outcomes:
measure: Changes in patients' self-assessment of dizziness
timeFrame: Baseline (Week 1) and Visit 8 (Week 27)
measure: Changes in patients' self-assessment of overall affect of symptoms
timeFrame: Baseline (Week 1) and Visit 8 (Week 27)
measure: Changes in patients' self-assessment of symptom impact on daily life function
timeFrame: Baseline (Week 1) and Visit 8 (Week 27)
measure: Changes in patients' self-assessment of depression
timeFrame: Baseline (Week 1) and Visit 8 (Week 27)
measure: Changes in patients' self-assessment of anxiety
timeFrame: Baseline (Week 1) and Visit 8 (Week 27)
Other outcomes:
measure: Change in patients' tinnitus from baseline to the end of treatment.
timeFrame: Baseline (Week 1) and Visit 8 (Week 27)
measure: Change in patients' hearing loss from baseline to the end of treatment.
timeFrame: Baseline (Week 1) and Visit 8 (Week 27)
Locations:
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
Study officials:
affiliation: Dent Neurologic Institute
name: Lixin Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: