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NCT05582837 | RECRUITING | Ménière

Treatment of Meniere's Disease With Migraine Medications
Sponsor:

University of California, Irvine

Information provided by (Responsible Party):

Hamid Djalilian

Brief Summary:

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.

Condition or disease

Ménière

Intervention/treatment

nortriptyline + topiramate

Phase

PHASE4

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : TRIPLE
Masking Description : No masking: care provider
Primary Purpose : TREATMENT
Official Title : Treatment of Meniere's Disease With Nortriptyline-Topiramate Stepwise Regimen: A Randomized Double-Blinded Clinical Trial
Actual Study Start Date : 2022-08-01
Estimated Primary Completion Date : 2026-12-30
Estimated Study Completion Date : 2026-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 25 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Treatment of Meniere's Disease With Migraine Medications

Location Details

NCT05582837

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

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

Orange, California, United States, 92868