RECRUITINGPhase 4INTERVENTIONAL

Treatment of Tinnitus With Migraine Medications

Treatment of Tinnitus With Migraine Medications: A Randomized Clinical Trial

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Treatments Being Tested

DRUG

Nortriptyline + topiramate

Treatment group 1

DRUG

Verapamil + paroxetine

Treatment group 2

OTHER

Placebo

Placebo comparator

Locations (1)

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

Orange, California, United States