RECRUITING

Treatment of Meniere's Disease With Migraine Medications

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Conditions

MénièreMeniere's Disease, medication, randomized, trial, migraine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-08-01
Study Completion:2026-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05582837

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients with active or frequent Meniere's Disease.
  2. 2. Male or female between the ages of 25 to 85 years.
  3. 3. Subject must be compliant with the medication and attend study visits.
  4. 4. Must be able to read and write in the English language to provide consenting.
  1. 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. 2. Subjects with history of surgery for Meniere's Disease.
  3. 3. Subject with history of an adverse reaction to medication being prescribed.
  4. 4. Subject suffers from a medical condition or has history that may be concerning to the investigator's clinical opinion.
  5. 5. Subjects with psychosis.
  6. 6. Subjects with neurological neoplasm.
  7. 7. All contraindications for the medications which prevent subjects from randomization will be considered as exclusion criteria.

Contacts and Locations

Study Contact

Hamid R Djalilian
CONTACT
(800) 263-9547
hdjalili@hs.uci.edu
Mehdi Abouzari
CONTACT
(714) 509-6096
mabouzar@hs.uci.edu

Principal Investigator

Hamid Djalilian, MD
PRINCIPAL_INVESTIGATOR
University of California, Irvine

Study Locations (Sites)

University of California, Irvine Medical Center ENT Clinic (Pavilion 2)
Orange, California, 92868
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Hamid Djalilian, MD, PRINCIPAL_INVESTIGATOR, University of California, Irvine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-01
Study Completion Date2026-12-30

Study Record Updates

Study Start Date2022-08-01
Study Completion Date2026-12-30

Terms related to this study

Keywords Provided by Researchers

  • Meniere's Disease, medication, randomized, trial, migraine

Additional Relevant MeSH Terms

  • Ménière