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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California, Irvine Medical Center ENT Clinic (Pavilion 2)
RECRUITING
Orange
Contact Information
Primary
Hamid R Djalilian
hdjalili@hs.uci.edu
(800) 263-9547
Backup
Mehdi Abouzari
mabouzar@hs.uci.edu
(714) 509-6096
Time Frame
Start Date: 2022-08-01
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 100
Treatments
Experimental: nortriptyline + topiramate
Nortriptyline (starting dose 7.5 mg) plus Topiramate (starting dose 10 mg) with appropriate dosage increase as necessary
Active_comparator: hydrochlorothiazide + triamterene + placebo
hydrochlorothiazide (starting dose 25 mg) plus triamterene (starting dose 37.5 mg) with placebo being added in case of a dosage increase
Sponsors
Leads: University of California, Irvine

This content was sourced from clinicaltrials.gov

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