Clinical trial NCT02158585: Study of Lamotrigine to Treat Ménière's Disease
Official title: Lamotrigine for Ménière's Disease: a Double-blind, Placebo-controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meniere's Disease
Ménière's Vertigo
Vertigo, Intermittent
Vertigo, Aural
Keywords: Lamotrigine
Lamictal
Anticonvulsant
Ménière's disease
Vertigo attack
Dizziness
Vestibular disorder
Lead sponsor: Dent Neuroscience Research Center
Sponsor class: OTHER
Collaborators: name: University at Buffalo
First posted: 2014-06-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group
timeFrame: Duration of 12-week pre-treatment and 12-week study period (treatment)
measure: Change in Ménière's Vertigo Attack Frequency Within Lamotrigine Group
timeFrame: Duration of 12-week pre-treatment and 12-week study period (treatment)
Secondary outcomes:
measure: Difference in Ménière's Vertigo Attacks in Three-Week Intervals Between Lamotrigine and Placebo Groups
timeFrame: Duration of Week 16 to 18
measure: Improvement in Pure Tone Average in the Affected Ear
timeFrame: Prior to randomization and at completion of 12-week study period
measure: Improvement in Symptoms Severity
timeFrame: 12-week pre-treatment period; 6 week titration; 12-week study period (treatment)
measure: DHI Scores
timeFrame: Baseline (Week 1) and end of study (Week 18)
Other outcomes:
Locations:
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
Study officials:
affiliation: Dent Neurologic Institute
name: Lixin Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: