Study of Lamotrigine to Treat Ménière's Disease

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dent Neuroscience Research Center
• Collaborators: Ernesto Diaz-Ordaz, MD; University at Buffalo
• Treatments: Anticonvulsants; Lamotrigine

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