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Treatment of Meniere s Disease with Nortriptyline-Topiramate Stepwise Regimen: A

UCI Specialty Area: Other, Surgery
Principal Investigator: Hamid Djalilian
Official Title: Treatment of Meniere s Disease with Nortriptyline-Topiramate Stepwise Regimen: A Randomized Double-Blinded Clinical Trial
A Study On:
Other

Study 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.

Eligibility

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.

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.

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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

  • Please read the information below and ask questions about anything that you do not understand. A
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  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
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