Lamotrigine for Ménière's Disease: a Double-blind, Placebo-controlled Pilot Study
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Meniere's Disease
- Sponsor
- Dent Neuroscience Research Center
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Lixin Zhang
Medical Director of the Dizziness and Balance Center
Dent Neuroscience Research Center
Eligibility Criteria
Inclusion Criteria
- •Male and female participants aged 18 years or older
- •Diagnosed with unilateral definite Ménière's disease according to the AAO-HNS 1995 criteria, confirmed by an ENT
- •Active vertigo: at least two Ménière's vertigo attacks (defined as lasting 20 minutes or longer and associated with tinnitus, ear fullness, or low frequency hearing loss and nausea/vomiting) every four weeks during the eight-week qualification period and at least two more Ménière's vertigo attacks during the lead-in phase prior to randomization
- •Documented unilateral lower frequency hearing loss defined as the four-tone average (arithmetic mean rounded to the nearest whole number) of the pure-tone thresholds at 0.25, 0.5, 1 and 2 kilohertz (kHz) more than or equal to 25 decibels (dB) of the worse audiogram during the six months before screening
- •Have tried diuretics for at least one month and discontinued treatment due to continued vertigo attacks
- •All other co-existing medical or psychiatric conditions are stable, and no greater than moderate severity
- •Willing to avoid pregnancy during the entirety of the study (abstinence or two forms of acceptable birth control, such as condoms and oral contraceptives)
Exclusion Criteria
- •Bilateral Ménière's disease
- •Current or past history of migraine
- •Any other neuro-otologic disease or major vestibular abnormality found during screening that could confound the evaluation of Ménière's symptoms
- •Previous intolerance or sensitivity to lamotrigine
- •On any prohibited medication within four weeks prior to the study
- •History of tympanostomy tubes with evidence of perforation or lack of closure
- •IT gentamicin injections or endolymphatic sac surgery within the last year
- •History of or current immunodeficiency disease, nephrolithiasis, hypertension, cardiac disease, arrhythmia, hypercholesterolemia, hemiplegic/basilar migraine, stroke, diabetes, vascular disease or kidney disease
- •Family history of unexplained deafness
- •Pregnant or breastfeeding
Arms & Interventions
Placebo
The placebo will match the lamotrigine dosage, frequency and duration.
Intervention: Placebo
Lamotrigine
Lamotrigine will be taken orally for the duration of 20 weeks, consisting of a six-week titration, 12-week study period, and two-week taper. Possible doses 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. Patients who withdraw 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.
Intervention: Lamotrigine
Outcomes
Primary Outcomes
Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group
Time Frame: Duration of 12-week pre-treatment and 12-week study period (treatment)
Measured with a daily questionnaire
Change in Ménière's Vertigo Attack Frequency Within Lamotrigine Group
Time Frame: Duration of 12-week pre-treatment and 12-week study period (treatment)
Measured with daily questionnaire
Secondary Outcomes
- Difference in Ménière's Vertigo Attacks in Three-Week Intervals Between Lamotrigine and Placebo Groups(Duration of Week 16 to 18)
- Improvement in Pure Tone Average in the Affected Ear(Prior to randomization and at completion of 12-week study period)
- Improvement in Symptoms Severity(12-week pre-treatment period; 6 week titration; 12-week study period (treatment))
- DHI Scores(Baseline (Week 1) and end of study (Week 18))