Recruiting
Phase 2

Lamotrigine & Bupropion

Sponsor:

Dent Neuroscience Research Center

Code:

NCT05420350

Conditions

Meniere Disease

Ménière's Vertigo

Vertigo, Intermittent

Vertigo, Aural

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lamotrigine and Bupropion

Placebo

Study Details

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.

Conditions

Meniere Disease

Ménière's Vertigo

Vertigo, Intermittent

Vertigo, Aural

Study ID

NCT05420350

Start date

Dec 16, 2020

Status verified date

Jun, 2022

Completion date

Dec, 2024

Anticipated

Primary completion date

Jul, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Lamotrigine and Bupropion

Lamotrigine will be taken orally for a duration of 28 weeks, consisting of a six-week titration, 20-week study period, and two-week taper. Possible doses are 25mg one a day, 50mg once a day, 50mg twice a day, 75mg twice a day during titration; 125mg twice a day for the study period; and 125mg once a day during the two-week taper. Patients who discontinue at any point of the study will have a two-week taper of lamotrigine.

Bupropion will be taken orally for the duration of 20 week at the dosage of 100mg twice a day.

placebo comparator: Placebo

The placebo will match the lamotrigine and bupropion dosage, frequency, and duration.

Interventions

Lamotrigine and Bupropion

Lamotrigine-oral pill taken once or twice a day with varying dosage per study timeline Bupropion-oral pill 100mg taken twice a day

Placebo

Oral pill matched with lamotrigine to be taken once or twice a day per study timeline Oral pill matched with bupropion to be taken twice a day

Primary outcome measure

  • Change in Ménière's vertigo attack frequency between groups [ Time Frame: Duration of lead-in to completion at week 30 ]
  • Change in Ménière's vertigo attack frequency lamotrigine alone compared to lamotrigine and bupropion [ Time Frame: Week 1 to Week 27 ]

Central Contacts and Locations

Central contacts

Maxwell Kahn, JD

716-250-7002mkahn@dentinstitute.com

Dawn Pytlik

716-250-3083dpytlik@dentinstitute.com

Locations

Dent Neurologic Institute

Recruiting

Amherst, New York, United States, 14226

Contacts

Maxwell Kahn, JD

716-250-7002mkahn@dentinstitute.com

Dawn Pytlik, AAS

716-250-3083dpytlik@dentinstitute.com

Principal Investigator:

Lixin Zhang, MD, PhD

More Information

Sponsor

Dent Neuroscience Research Center

Last update posted

Jun 21, 2022

Last verified

Jun, 2022

Keywords

  • Lamictal
  • Lamotrigine
  • Anticonvulsant
  • Meniere's Disease
  • Vertigo attack
  • Dizziness
  • Vestibular disorder
  • Wellbutrin
  • Bupropion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dent Neuroscience Research Center on 2022-06-21.