Study of Lamotrigine to Treat Ménière's Disease

Meniere's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158585
• Other study ID #: Zhang-001
• Status: Completed
• Phase: Phase 2
• Start date: June 2014
• Est. completion date: March 2017

Study information

• Verified date: May 2022
• Source: Dent Neuroscience Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dizziness
• Meniere Disease
• Meniere's Disease
• Ménière's Vertigo
• Vertigo
• Vertigo, Aural
• Vertigo, Intermittent

Intervention

Drug:
• Lamotrigine
Lamotrigine will be taken orally on a daily basis for the duration of 20 weeks, consisting of a six-week titration, 12-week study period, and two-week taper. Possible doses for patients 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. Each increase in dose will be maintained for two weeks before deciding to further increase or decrease based on tolerability. Patients who discontinue 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.
• Placebo
The placebo will match the lamotrigine dosage, frequency and duration.

Locations

Country	Name	City	State
United States	Dent Neurologic Institute	Amherst	New York

Sponsors (2)

Lead Sponsor	Collaborator
Dent Neuroscience Research Center	University at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Ménière's Vertigo Attack Frequency Between Lamotrigine and Placebo Group	Measured with a daily questionnaire	Duration of 12-week pre-treatment and 12-week study period (treatment)
Primary	Change in Ménière's Vertigo Attack Frequency Within Lamotrigine Group	Measured with daily questionnaire	Duration of 12-week pre-treatment and 12-week study period (treatment)
Secondary	Difference in Ménière's Vertigo Attacks in Three-Week Intervals Between Lamotrigine and Placebo Groups	Measured with a daily questionnaire.	Duration of Week 16 to 18
Secondary	Improvement in Pure Tone Average in the Affected Ear	Measured using the average of 500, 1000, 2000, and 3000 Hz presentation level (dB)	Prior to randomization and at completion of 12-week study period
Secondary	Improvement in Symptoms Severity	Based of rating on Clinical Global Impression of Change (CGI) score of blinded physician	12-week pre-treatment period; 6 week titration; 12-week study period (treatment)
Secondary	DHI Scores	Dizziness Handicap Inventory (DHI). Minimum score=0. Maximum score=100. Higher scores mean a worse outcome.	Baseline (Week 1) and end of study (Week 18)