Phase 2 N=15 Randomized Quadruple-blind Treatment

Study of Lamotrigine to Treat Ménière's Disease

Meniere's Disease · Ménière's Vertigo · Vertigo, Intermittent · Vertigo, Aural

Bottom Line

View on ClinicalTrials.gov: NCT02158585 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group — 18.88; 18.00; 13.50; 4.57 Average Total Number of Vertigo Attacks — p=0.5618

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Lamotrigine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Dent Neuroscience Research Center
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group	18.88; 18.00; 13.50; 4.57	0.5618
PRIMARY Change in Ménière's Vertigo Attack Frequency Within Lamotrigine Group	18.00; 4.57	0.03429 sig
SECONDARY Difference in Ménière's Vertigo Attacks in Three-Week Intervals Between Lamotrigine and Placebo Groups	4.86; 0.29	0.0092 sig
SECONDARY Improvement in Pure Tone Average in the Affected Ear	3; 5	—
SECONDARY Improvement in Symptoms Severity	3; 6	—
SECONDARY DHI Scores	57.50; 37.14; 49.43; 38.29	0.0385 sig

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02158585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.