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RECRUITINGPhase 4INTERVENTIONAL

Treatment of Meniere's Disease With Migraine Medications

Treatment of Meniere's Disease With Nortriptyline-Topiramate Stepwise Regimen: A Randomized Double-Blinded Clinical Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

nortriptyline + topiramate

nortriptyline (7.5mg) + topiramate (10mg) taken 1x per day and escalate weekly as needed for 8 weeks

Locations (1)

University of California, Irvine Medical Center ENT Clinic (Pavilion 2)
Orange, California, United States