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Study of Lamotrigine to Treat Ménière's Disease

NCT02158585 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-06-22

Study results available
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Summary

This double-blinded study evaluates the frequency of vertigo attacks and the quality of life of patients diagnosed with Ménière's disease after being randomly assigned to take a placebo or lamotrigine.

Conditions

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

Interventions

DRUG

Lamotrigine

Lamotrigine will be taken orally on a daily basis for the duration of 20 weeks, consisting of a six-week titration, 12-week study period, and two-week taper. Possible doses for patients are 25mg twice a day, 50mg twice a day, and 100 mg twice a day during titration; 150mg twice a day for the 12-week study period; 150mg once a day for Week 1 of the taper; and 75mg once a day for Week 2 of the taper. Each increase in dose will be maintained for two weeks before deciding to further increase or decrease based on tolerability. Patients who discontinue at any point of the study will have a two-week taper consisting of the current dose once a day for one week followed by half the dose once a day for another week.

DRUG

Placebo

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

Sponsors & Collaborators

  • University at Buffalo

    collaborator OTHER

  • 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
2014-06-30
Primary Completion
2017-03-31
Completion
2017-03-31

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 NCT02158585 on ClinicalTrials.gov