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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
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.
The placebo will match the lamotrigine dosage, frequency and duration.
Dent Neurologic Institute
Amherst, New York, United States
Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group
Measured with a daily questionnaire
Time frame: Duration of 12-week pre-treatment and 12-week study period (treatment)
Change in Ménière's Vertigo Attack Frequency Within Lamotrigine Group
Measured with daily questionnaire
Time frame: Duration of 12-week pre-treatment and 12-week study period (treatment)
Difference in Ménière's Vertigo Attacks in Three-Week Intervals Between Lamotrigine and Placebo Groups
Measured with a daily questionnaire.
Time frame: Duration of Week 16 to 18
Improvement in Pure Tone Average in the Affected Ear
Measured using the average of 500, 1000, 2000, and 3000 Hz presentation level (dB)
Time frame: Prior to randomization and at completion of 12-week study period
Improvement in Symptoms Severity
Based of rating on Clinical Global Impression of Change (CGI) score of blinded physician
Time frame: 12-week pre-treatment period; 6 week titration; 12-week study period (treatment)
DHI Scores
Dizziness Handicap Inventory (DHI). Minimum score=0. Maximum score=100. Higher scores mean a worse outcome.
Time frame: Baseline (Week 1) and end of study (Week 18)
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