Treatment of Meniere's Disease With Nortriptyline-Topiramate Stepwise Regimen: A Randomized Double-Blinded Clinical Trial
University of California, Irvine
Summary
Meniere's disease (MD) is a chronic disease with a variety of fluctuating signs and symptoms, which include vertigo, hearing loss, tinnitus (ringing noise in the ear), aural pressure (feeling of ear fullness), and disequilibrium (lack of stability). Vertigo represents one of the most common and distressing problems in MD patients, and it causes various somatic and psychological disorders that interfere with the patient's quality of life. Despite the large economic and emotional impact of symptoms in MD patients, there is no FDA-approved medication to treat this debilitating condition. As such, our objective in this study is to evaluate the therapeutic potential of novel medications in treating MD that have previously shown astonishing promise in our clinical practice.
Description
This study is 8 weeks in duration. There are two arms in the experiment: the first is nortriptyline (7.5 mg) plus topiramate (10 mg), the second is hydrochlorothiazide (25 mg) plus triamterene (37.5 mg) with placebo being added in case of a dosage increase. This is a double-blinded trial. Participants will be randomized to one arm for the duration of the trial using simple randomization with a computer-generated number. Both groups may receive dosage increases weekly if symptoms do not improve. Symptomatic survey scores from each arm will be obtained before and after treatment and weekly. An u…
Eligibility
- Age range
- 25–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with active or frequent Meniere's Disease. 2. Male or female between the ages of 25 to 85 years. 3. Subject must be compliant with the medication and attend study visits. 4. Must be able to read and write in the English language to provide consenting. Exclusion Criteria: 1. Pregnancy will result in automatic exclusion from the study. A urine pregnancy test to rule out pregnancy for all women who are of childbearing potential. 2. Subjects with history of surgery for Meniere's Disease. 3. Subject with history of an adverse reaction to medication being prescribe…
Interventions
- Drugnortriptyline + topiramate
nortriptyline (7.5mg) + topiramate (10mg) taken 1x per day and escalate weekly as needed for 8 weeks
Location
- University of California, Irvine Medical Center ENT Clinic (Pavilion 2)Orange, California