Using migraine medications to manage acute tinnitus
Management of Acute Tinnitus With Migraine Medications: A Randomized Clinical Trial
This study is testing if migraine medications can help people with acute tinnitus feel better over eight weeks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 25 Years to 85 Years |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT06799169 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of migraine medications in managing acute tinnitus, a condition that significantly impacts quality of life. The study involves two treatment arms: one group will receive nortriptyline and topiramate, while the other will receive verapamil and paroxetine, over an 8-week period. Participants will be randomly assigned to one of the treatment groups and will undergo weekly assessments to monitor their symptoms and adjust dosages as necessary. The trial is double-blinded to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 25 to 85 with mild to moderate tinnitus who can comply with medication and study visits.
Not a fit: Patients with severe tinnitus, contraindications to the study medications, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new pharmacological approach to alleviate the distress caused by acute tinnitus.
How similar studies have performed: While there have been studies exploring medications for tinnitus, this specific combination approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with mild to moderate tinnitus. * Male or female between the ages of 25 to 85 years. * Subjects must be compliant with the medication and attend study visits. * Must be able to read and write in the English language to provide consent. Exclusion Criteria: * Pregnancy will result in automatic exclusion from the study. Rule out of pregnancy will be done by urine pregnancy test to confirm the situation for all women who are of childbearing potential. * Subjects with a history of an adverse reaction to medication being prescribed. * Subjects suffering from a medical condition or have a history that may be concerning to the investigator's clinical opinion. * All contraindications for the medications that 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: Mehdi Abouzari, MD, PhD — University of California, Irvine
- Study coordinator: Mehdi Abouzari, MD, PhD
- Email: mabouzar@hs.uci.edu
- Phone: (714) 509-6096
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.