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ACTIVE NOT RECRUITING
NCT06799169
PHASE4

Management of Acute Tinnitus With Migraine Medications

Sponsor: University of California, Irvine

View on ClinicalTrials.gov

Summary

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.

Official title: Management of Acute Tinnitus With Migraine Medications: A Randomized Clinical Trial

Key Details

Gender

All

Age Range

25 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-06-01

Completion Date

2026-12

Last Updated

2025-10-10

Healthy Volunteers

No

Conditions

Interventions

DRUG

Nortriptyline

Nortriptyline (7.5 mg) plus Topiramate (10 mg) taken by mouth daily with appropriate dosage increase as necessary

DRUG

Topiramate

Nortriptyline (7.5 mg) plus Topiramate (10 mg) taken by mouth daily with appropriate dosage increase as necessary

DRUG

Paroxetine

Verapamil (30 mg) plus Paroxetine (4 mg) taken by mouth daily with appropriate dosage increase as necessary

DRUG

Verapamil

Verapamil (30 mg) plus Paroxetine (4 mg) taken by mouth daily with appropriate dosage increase as necessary

Locations (1)

University of California, Irvine Medical Center ENT Clinic (Pavilion 2)

Orange, California, United States