Study of Lamotrigine to Treat Ménière's Disease

Condition(s) targeted: Meniere's Disease; Ménière's Vertigo; Vertigo, Intermittent; Vertigo, Aural

Intervention: Lamotrigine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Dent Neuroscience Research Center

Official(s) and/or principal investigator(s):
Lixin Zhang, MD, PhD, Principal Investigator, Affiliation: Dent Neurologic Institute

Overall contact:
Jessica O'Neill, MPH, Phone: 716-250-3083, Email: joneill@dentinstitute.com

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.

Official title: Lamotrigine for Ménière's Disease: a Double-blind, Placebo-controlled Pilot Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in Ménière's vertigo attack frequency

Secondary outcome:

Responder rate

Change in length of vertigo attack-free intervals

Change in hearing loss

Change in symptom severity scores on the Ménière's Disease Patients-Oriented Severity Index (MDPOSI)

Change in Tinnitus Handicap Inventory (THI) score

Rating of Meniere's disease severity on the Clinical Global Impression Scale

Change in Dizziness Handicap Inventory (DHI) score

Change in rating of symptom impact on daily life on the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) Ménière's disease self-assessment

Change in number and percentage of vertigo attack-free days per 28 days period

Change in number and percentage of patients who are vertigo attack-free

Rating of drug effect on the Clinical Global Impression Scale

Rating of total improvement on the Clinical Global Impression Scale

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Jessica O'Neill, MPH, Phone: 716-250-3083, Email: joneill@dentinstitute.com

Dent Neurologic Institute, Amherst, New York 14226, United States; Recruiting
Jessica O'Neill, MPH, Phone: 716-250-3083, Email: joneill@dentinstitute.com
Dawn Pytlik, AAS, Phone: 716-250-3083, Email: dpytlik@dentinstitute.com
Lixin Zhang, MD, PhD, Principal Investigator

Starting date: June 2014
Last updated: July 15, 2015