Treatment of Tinnitus With Migraine Medications: A Randomized Clinical Trial

Who is this study for? Adult patients with Tinnitus
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California, Irvine Medical Center ENT Clinic (Pavilion 2)
RECRUITING
Orange
Contact Information
Primary
Hamid R Djalilian, MD
hdjalili@hs.uci.edu
800-263-9547
Time Frame
Start Date: 2019-09-26
Estimated Completion Date: 2023-12-30
Participants
Target number of participants: 150
Treatments
Experimental: Nortriptyline + topiramate
Nortriptyline (7.5 mg) plus topiramate (10 mg) in a single pill initially taken once daily. Dose may be increased as directed by care provider by 7.5mg weekly (to a maximum of 60mg) for nortriptyline, and by 10mg weekly (maximum 80mg) for topiramate.
Experimental: Verapamil + paroxetine
Verapamil (30 mg) plus paroxetine (4 mg) in a single pill initially taken once daily. Dose may be increased as directed by care provider by 30mg weekly (to a maximum of 240mg) for verapamil, and by 4mg weekly (maximum 32mg) for paroxetine.
Placebo_comparator: Placebo
Placebo pill.
Related Therapeutic Areas
Sponsors
Leads: University of California, Irvine

This content was sourced from clinicaltrials.gov