NCT05582837RecruitingPhase 4
Treatment of Meniere's Disease With Migraine Medications
Treatment of Meniere's Disease With Nortriptyline-Topiramate Stepwise Regimen: A Randomized Double-Blinded Clinical Trial
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 7 Oct 2021
- Start date
- 1 Aug 2022
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- University of California, Irvine
- Diseases
- Migraine
- NCT number
- NCT05582837
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 40
- From 1 Aug 2022 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- All contraindications for the medications which prevent subjects from randomization will be considered as exclusion criteria.
Other illness
- 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.
Other
- 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 psychosis.
- Subjects with neurological neoplasm.
Who the study is looking for
- 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.
Age in the registry: 25 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California, Irvine Medical Center ENT Clinic (Pavilion 2) Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.