Lamotrigine and Bupropion for Vertigo, Aural

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Dent Neurologic Institute, Amherst, NY
Vertigo, Aural+5 More
Lamotrigine and Bupropion - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Vertigo, Aural
  • Vertigo
  • Ménière's Vertigo

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Vertigo, Aural

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Baseline (Week 1) and Visit 8 (Week 27)

Week 27
Change in patients' hearing loss from baseline to the end of treatment.
Change in patients' tinnitus from baseline to the end of treatment.
Changes in patients' self-assessment of anxiety
Changes in patients' self-assessment of depression
Changes in patients' self-assessment of dizziness
Changes in patients' self-assessment of overall affect of symptoms
Changes in patients' self-assessment of symptom impact on daily life function
Week 30
Change in Ménière's vertigo attack frequency between groups
Week 27
Change in Ménière's vertigo attack frequency lamotrigine alone compared to lamotrigine and bupropion

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Vertigo, Aural

Trial Design

2 Treatment Groups

Lamotrigine and Bupropion
1 of 2
Placebo
1 of 2
Active Control
Non-Treatment Group

34 Total Participants · 2 Treatment Groups

Primary Treatment: Lamotrigine and Bupropion · Has Placebo Group · Phase 2

Lamotrigine and Bupropion
Drug
ActiveComparator Group · 1 Intervention: Lamotrigine and Bupropion · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (week 1) and visit 8 (week 27)
Closest Location: Dent Neurologic Institute · Amherst, NY
Photo of new york 1Photo of new york 2Photo of new york 3
2009First Recorded Clinical Trial
2 TrialsResearching Vertigo, Aural
30 CompletedClinical Trials

Who is running the clinical trial?

Cures Within ReachOTHER
18 Previous Clinical Trials
1,680 Total Patients Enrolled
Dent Neuroscience Research CenterLead Sponsor
4 Previous Clinical Trials
67 Total Patients Enrolled
1 Trials studying Vertigo, Aural
15 Patients Enrolled for Vertigo, Aural
Dent Family FoundationUNKNOWN
Lixin Zhang, MD, PhDPrincipal InvestigatorDent Neurologic Institute
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Vertigo, Aural
15 Patients Enrolled for Vertigo, Aural

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male or female aged 18 years or older.
You are experiencing vertigo.
You are 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.
You are willing to comply with all study procedures and are available for the duration of the study.
You are able to provide informed written consent, including agreement to privacy language either within the informed consent or in ancillary documents compliant with HIPAA before the initiation of any study-related procedures.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.