Study of Lamotrigine to Treat Ménière's Disease

Dent Neuroscience Research Center

Status and phase: Completed; Phase 2

Conditions: Ménière's Vertigo; Vertigo, Intermittent; Vertigo, Aural; Meniere's Disease

Treatments: Drug: Placebo; Drug: Lamotrigine

Study type: Interventional

Funder types: Other

Identifiers

NCT02158585

Zhang-001

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

The placebo will match the lamotrigine dosage, frequency and duration.

Treatment:

Drug: Placebo

Lamotrigine

Active Comparator group

Description:

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.

Treatment:

Drug: Lamotrigine