Treatment of Tinnitus With Migraine Medications

Tinnitus Clinical Trial

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

Status Recruiting

Clinical Trial 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. It is well-understood that many factors, such as poor education, lower income, or occupational, and recreational activity associated with high noise exposure, influences 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, we intend to use medications for patients with tinnitus in order to decrease the impact of tinnitus on their daily life and activities.

Clinical Trial Description

This study is 8 weeks in duration. There are three arms in the experiment: the first is nortriptyline (7.5 mg) plus topiramate (10 mg), the second is verapamil (30 mg) plus paroxetine (4 mg), and the third is a placebo group. This is a double-blinded trial. Participants will be randomized to one arm for the duration of the trial using simple randomization with a computer-generated number. Both medication combinations and placebo may include dosage increases weekly if symptoms do not improve. Nortriptyline may be increased by 7.5mg weekly (to a maximum of 60mg), topiramate by 10mg weekly (maximum 80mg), verapamil by 30mg weekly (maximum 240mg), and paroxetine by 4mg weekly (maximum 32mg). Symptomatic survey scores from each arm will be obtained before and after treatment and weekly. An unblinded neurotologist attending (Dr. Harrison Lin) will also become involved with patients' treatments as they start to report changes in symptoms in order to monitor their safety and provide advice on change in dosage if patients have questions. ;

Related Conditions & MeSH terms

• Migraine Disorders
• Tinnitus
• Tinnitus, Subjective

• NCT number: NCT04404439
• Study type: Interventional
• Source: University of California, Irvine
• Contact: Hamid R Djalilian, MD
• Phone: 800-263-9547
• Email: hdjalili@hs.uci.edu
• Status: Recruiting
• Phase: Phase 4
• Start date: September 26, 2019
• Completion date: December 30, 2023