NCT06799169SuspendedPhase 4
Management of Acute Tinnitus With Migraine Medications
Management of Acute Tinnitus With Migraine Medications: A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Reason given: Enrollment temporarily paused pending IRB continuing review; recruitment expected to resume.
Brief summary (registry, in English)
Tinnitus represents one of the most common and distressing otologic problems, and it causes various somatic and psychological disorders that interfere with the quality of life. Despite too many research projects on finding the mechanism of tinnitus, its pathophysiology remains poorly understood. It is well understood that many factors, such as poor education, lower income, or occupational, and recreational activity associated with high noise exposure, influence the prevalence and risk of tinnitus. Although the economic and emotional impact of tinnitus is large, there is currently no FDA-approved medication to treat this condition. However, there are pharmacological options to address the stress, anxiety, and depression that are caused by tinnitus. In this project, the investigators intend to use medications for patients with acute tinnitus to decrease the impact of tinnitus in their daily lives and activities. There are some studies on medications treating tinnitus; however, there are few randomized clinical trials to prove the efficacy of the treatment. The frequency and loudness of tinnitus will be measured before and after the course. Functional MRI of the brain will be obtained to view any changes that may occur before and after the treatment.
- Status (registry)
- Suspended
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 29 Aug 2024
- Start date
- 1 Jun 2025
- Primary completion date
- Dec 2030
- Lead sponsor
- University of California, Irvine
- Diseases
- Migraine
- NCT number
- NCT06799169
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 that prevent subjects from randomization will be considered as exclusion criteria.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
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) | Orange | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.