Study of Lamotrigine to Treat Ménière's Disease

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