Management of Acute Tinnitus With Migraine Medications

Last updated: April 29, 2025
Sponsor: University of California, Irvine
Overall Status: Active - Recruiting

Phase

4

Condition

Tinnitus

Migraine (Adult)

Oral Facial Pain

Treatment

Nortriptyline

Verapamil

Paroxetine

Clinical Study ID

NCT06799169
4863
  • Ages 25-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with mild to moderate tinnitus.

  • Male or female between the ages of 25 to 85 years.

  • Subjects must be compliant with the medication and attend study visits.

  • Must be able to read and write in the English language to provide consent.

Exclusion

Exclusion Criteria:

  • Pregnancy will result in automatic exclusion from the study. Rule out of pregnancywill be done by urine pregnancy test to confirm the situation for all women who areof childbearing potential.

  • Subjects with a history of an adverse reaction to medication being prescribed.

  • Subjects suffering from a medical condition or have a history that may be concerningto the investigator's clinical opinion.

  • All contraindications for the medications that prevent subjects from randomizationwill be considered as exclusion criteria.

Study Design

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Nortriptyline
Phase: 4
Study Start date:
June 01, 2025
Estimated Completion Date:
September 30, 2026

Study Description

This study is 8-weeks in duration. There are two arms in the experiment: the first is nortriptyline (7.5 mg) plus topiramate (10 mg), the second is verapamil (240 mg) plus paroxetine (32 mg). 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 groups may receive dosage increases weekly if symptoms do not improve. Symptomatic survey scores from each arm will be obtained before and after treatment and weekly. An unblinded clinical researcher 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.

Connect with a study center

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

    Orange, California 92868
    United States

    Active - Recruiting

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