Meniere's Disease Clinical Trial
Official title:
Lamotrigine for Ménière's Disease: a Double-blind, Placebo-controlled Pilot Study
NCT number | NCT02158585 |
Other study ID # | Zhang-001 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2014 |
Est. completion date | March 2017 |
Verified date | May 2022 |
Source | Dent Neuroscience Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Dent Neurologic Institute | Amherst | New York |
Lead Sponsor | Collaborator |
---|---|
Dent Neuroscience Research Center | University at Buffalo |
United States,
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) |
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