Study of Lamotrigine to Treat Ménière's Disease
Condition: Meniere's Disease; Ménière's Vertigo; Vertigo, Intermittent; Vertigo, Aural
MeSH terms: Vertigo; Meniere Disease; Dizziness
Intervention: Lamotrigine; Placebo
Intervention description: 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.
Intervention MeSH terms: Lamotrigine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lamotrigine; Lamictal; Anticonvulsant; Ménière's disease; Vertigo attack; Dizziness; Vestibular disorder

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.
    

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