Treatment of Meniere's Disease With Migraine Medications
ConditionMénière
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age25-85
SponsorUniversity of California, Irvine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with active or frequent Meniere's Disease.
Male or female between the ages of 25 to 85 years.
Subject must be compliant with the medication and attend study visits.
Must be able to read and write in the English language to provide consenting.
Disqualifiers
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.
Subjects with history of surgery for Meniere's Disease.
Subject with history of an adverse reaction to medication being prescribed.
Subject suffers from a medical condition or has history that may be concerning to the investigator's clinical opinion.
Trial design
Design model
Parallel
Treatments tested in this trial
nortriptyline + topiramate
Drugnortriptyline (7.5mg) + topiramate (10mg) taken 1x per day and escalate weekly as needed for 8 weeks
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: nortriptyline + topiramateExperimental treatment 1 intervention
Group B: hydrochlorothiazide + triamterene + placeboActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Subjective improvement of Meniere's Disease
The primary outcome variable is derived from the validated Meniere's Disease Outcome Questionnaire (MDOQ) with 18 multiple-choice questions to compare quality of life before and after treatment. The question multiple choices are rated on a scale from 0 to 4 where the higher score indicates the higher quality of life. For each patient, the sum of his/her answers is divided (and x100) by the maximum possible scores for the pre-treatment questions and the post-treatment questions, separately. The outcome measure is the absolute change from pre- to post-treatment scores. Two-sample t test will be used to compare the outcome variable between the two treatment groups.
Time frame
8 weeksSecondary outcomes
1
Visual analog scale (VAS)
Subjective improvement in tinnitus loudness severity based on a visual analog scale (VAS). The VAS is scored from 0 to 10, with a higher score representing an increased severity of tinnitus.
Time frame
8 weeks2
Perceived Stress Scale (PSS)
Subjective improvement in stress based on perceived stress scale (PSS). The PSS is scored from 0 to 40, with higher scores indicating higher perceived stress.
Time frame
8 weeks3
Sleep Quality Index (SQI)
Subjective improvement in sleep quality based on sleep quality index (SQI). The SQI is scored from 0 to 21, with higher scores indicating worse quality of sleep.
Time frame
8 weeks4
Dizziness handicap index (DHI)
Subjective improvement in dizziness handicap index (DHI). There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness.
Time frame
8 weeksSponsors and contacts
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Source ClinicalTrials.gov