NCT04404439CompletedPhase 4
Treatment of Tinnitus With Migraine Medications
Treatment of Tinnitus With Migraine Medications: A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
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. In addition, it contributes significant costs to the healthcare system. However, the mechanisms of tinnitus are poorly understood. and there is currently no FDA-approved medication to treat this condition. Current pharmacological treatment options address the stress, anxiety, and depression that are caused by tinnitus. There is an increased evidence of an epidemiological and mechanistic association between tinnitus and migraine. Therefore, in this study, we intended to evaluate the effectiveness of two combinations of migraine medications on patients with moderate to severe tinnitus by comparing them to placebo.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 78 (actual)
- First submitted
- 17 May 2020
- Start date
- 26 Sept 2019
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- University of California, Irvine
- Diseases
- Migraine
- NCT number
- NCT04404439
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 78
- From 26 Sept 2019 to the primary completion date, 30 Dec 2023
- 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
- 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 investigators clinical opinion.
Other
- Pregnancy will result in automatic exclusion from the study. Rule out of pregnancy will be done by a urine pregnancy test to confirm the situation for all women who are of child bearing potential.
Who the study is looking for
- Patients with moderate to severe tinnitus.
- 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. Pick your city on the disease page 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 | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.