Study of Lamotrigine to Treat Ménière's Disease
Status: | Recruiting |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | June 2014 |
End Date: | April 2016 |
Contact: | Jessica O'Neill, MPH |
Email: | joneill@dentinstitute.com |
Phone: | 716-250-3083 |
Lamotrigine for Ménière's Disease: a Double-blind, Placebo-controlled Pilot Study
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.
of patients diagnosed with Ménière's disease after being randomly assigned to take a placebo
or lamotrigine.
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
We found this trial at
1
site
Amherst, New York 14226
Principal Investigator: Lixin Zhang, MD, PhD
Phone: 716-250-3083
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