Expired Study
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Amherst, New York 14226


Purpose:

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.


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


NCT ID:

NCT02158585


Primary Contact:

Principal Investigator
Lixin Zhang, MD, PhD
Dent Neurologic Institute


Backup Contact:

N/A


Location Contact:

Amherst, New York 14226
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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