Study of Lamotrigine to Treat Ménière's Disease
Meniere's Disease, Ménière's Vertigo, Vertigo, Intermittent
About this trial
This is an interventional treatment trial for Meniere's Disease focused on measuring Lamotrigine, Lamictal, Anticonvulsant, Ménière's disease, Vertigo attack, Dizziness, Vestibular disorder
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
- Current diseases or conditions that may be associated with an altered perception of processing stimuli
- Current severe medical condition(s) that in the view of the investigator prohibits participation
- Previously used the investigational drug
- Current non-vertiginous dizziness (orthostatic or panic disorder) unless it could be clearly differentiated from Ménière's attacks by the participant
Sites / Locations
- Dent Neurologic Institute
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo
Lamotrigine
The placebo will match the lamotrigine dosage, frequency and duration.
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.