Treatment of Meniere's Disease With Migraine Medications
Treatment of Meniere's Disease With Nortriptyline-Topiramate Stepwise Regimen: A Randomized Double-Blinded Clinical Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 25 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Symptomatic survey scores from each arm will be obtained before and after treatment and weekly."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests migraine medicines to treat Meniere's disease. It is for adults ages 25 to 85 with active or frequent symptoms. Meniere's disease can cause a spinning feeling, hearing loss, ringing or fullness in the ear, and trouble with balance.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have active or frequent Meniere's disease.
- Be 25 to 85 years old.
- Be able to take the medicine as directed and attend study visits.
- Be able to read and write in English to give consent to join.
Who can't join
- Are pregnant. Women who could become pregnant must have a urine pregnancy test.
- Have had surgery for Meniere's disease.
- Have had a bad reaction to the medicine being prescribed.
- Have a health condition or medical history that the study doctor finds concerning.
- Have psychosis, a condition that makes it hard to tell what is real.
- Have a tumor in the nervous system, which includes the brain, spinal cord, and nerves.
- Have any medical reason that makes the study medicines unsafe for you.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 prescribed. 4. Subject suffers from a medical condition or has history that may be concerning to the investigator's clinical opinion. 5. Subjects with psychosis. 6. Subjects with neurological neoplasm. 7. All contraindications for the medications which prevent subjects from randomization will be considered as exclusion criteria.
Study sites (1)
CA
- University of California, Irvine Medical Center ENT Clinic (Pavilion 2) · Orange, CA 92868Hamid R Djalilian, MD · Study contact · 800-263-9547 · hdjalili@hs.uci.eduMehdi Abouzari, MD, PhD · Study contact · 714-509-6096 · mabouzar@hs.uci.eduHamid R Djalilian, MD · Principal investigatorMehdi Abouzari, MD, PhD · Sub-investigatorMore trials in Orange