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Lamotrigine and Bupropion for Meniere's Disease

NCT05420350 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-06-21

No results posted yet for this 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.

Conditions

  • Meniere Disease
  • Ménière's Vertigo
  • Vertigo, Intermittent
  • Vertigo, Aural

Interventions

DRUG

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

DRUG

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

Sponsors & Collaborators

  • Cures Within Reach

    collaborator OTHER

  • Dent Family Foundation

    collaborator UNKNOWN

  • Dent Neuroscience Research Center

    lead OTHER

Principal Investigators

  • Lixin Zhang, MD, PhD · Dent Neurologic Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2024-07-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05420350 on ClinicalTrials.gov