Using migraine medications to treat Meniere's disease
Treatment of Meniere's Disease With Nortriptyline-Topiramate Stepwise Regimen: A Randomized Double-Blinded Clinical Trial
This study is testing whether migraine medications can help people with Meniere's disease feel better by reducing their vertigo, hearing loss, and tinnitus.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 25 Years to 85 Years |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT05582837 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of migraine medications in treating Meniere's disease, a chronic condition characterized by vertigo, hearing loss, and tinnitus. The study will last for 8 weeks and involves two treatment arms: one group will receive nortriptyline and topiramate, while the other will receive hydrochlorothiazide and triamterene, with the possibility of placebo. Participants will be randomly assigned to one of the treatment groups and will undergo weekly assessments of their symptoms. The trial is double-blinded to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25 to 85 with active or frequent Meniere's disease.
Not a fit: Patients who have undergone surgery for Meniere's disease or have a history of adverse reactions to the medications being tested may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from Meniere's disease.
How similar studies have performed: While there is limited research on this specific approach, the use of migraine medications for Meniere's disease is a novel concept that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Orange, California
- University of California, Irvine Medical Center ENT Clinic (Pavilion 2) — Orange, California, United States (Recruiting)
Study contacts
- Principal investigator: Hamid Djalilian, MD — University of California, Irvine
- Study coordinator: Hamid R Djalilian
- Email: hdjalili@hs.uci.edu
- Phone: (800) 263-9547
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.