Lamotrigine and Bupropion for Vertigo, Aural
Phase-Based Progress Estimates
Effectiveness
Safety
Dent Neurologic Institute, Amherst, NY
Vertigo, Aural+5 More
Lamotrigine and Bupropion - DrugEligibility
18+
All Sexes
What conditions do you have?
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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
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
This is further along than 68% of similar trials
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: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial 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
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 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.
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