Treatment of Tinnitus With Migraine Medications

Completed · Phase 4 · Has a placebo group

Conditions studied: Tinnitus, Subjective, Tinnitus

In brief

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.

Key facts

Study ID

NCT04404439

Run by

University of California, Irvine

People needed

78

Starts

2019-09-26

Expected to finish

2023-12-30

Last updated by the study team

2026-04-16

Who can join

Age: 25 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.
• All contraindications for the medications which prevent subjects from randomization will be considered as exclusion criteria.

Where it is running

• University of California, Irvine Medical Center ENT Clinic (Pavilion 2) — Orange, California, United States

Full record on ClinicalTrials.gov

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