Treatment of Meniere's Disease With Migraine Medications
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: nortriptyline + topiramate.
- Who it may be relevant to
- Registry conditions: Ménière. Basic parameters: 25 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Treatment of Meniere's Disease With Nortriptyline-Topiramate Stepwise Regimen: A Randomized Double-Blinded Clinical Trial
Overview
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.
Detailed 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 unblinded clinical researcher will also become involved with patients' treatments as they start to report changes in symptoms in order to monitor their safety and provide advice on change in dosage if patients have questions.
Interventions
- Drug nortriptyline + topiramate
nortriptyline (7.5mg) + topiramate (10mg) taken 1x per day and escalate weekly as needed for 8 weeks
Primary outcome measures
- Subjective improvement of Meniere's Disease [Time frame: 8 weeks]
Secondary outcome measures (7)
- Visual analog scale (VAS) [Time frame: 8 weeks]
- Perceived Stress Scale (PSS) [Time frame: 8 weeks]
- Sleep Quality Index (SQI) [Time frame: 8 weeks]
- Dizziness handicap index (DHI) [Time frame: 8 weeks]
- Tinnitus Functional Index (TFI) [Time frame: 8 weeks]
- Meniere's Disease Outcomes Questionnaire (MDOQ) [Time frame: 8 weeks]
- Patient Health Questionnaire (PHQ) [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Subjects with psychosis.
- Subjects with neurological neoplasm.
- All contraindications for the medications which prevent subjects from randomization will be considered as exclusion criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California, Irvine Medical Center ENT Clinic (Pavilion 2) — Orange
Identifiers
NCT: NCT05582837 · 20216445