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NCT06799169 | RECRUITING | Tinnitus

Management of Acute Tinnitus With Migraine Medications
Sponsor:

University of California, Irvine

Information provided by (Responsible Party):

Mehdi Aboumari

Brief 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.

Condition or disease

Ringing

Intervention/treatment

Nortriptyline

Topiramate

Paroxetine

Verapamil

Phase

PHASE4

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : TRIPLE
Masking Description : The principal investigator, provider, lead researchers and the subjects will be masked throughout the duration of the clinical trial. Solely the clinical coordinator will be unmasked during the study.
Primary Purpose : TREATMENT
Official Title : Management of Acute Tinnitus With Migraine Medications: A Randomized Clinical Trial
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2026-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 25 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 Criteria
  • * Pregnancy will result in automatic exclusion from the study. Rule out of pregnancy will be done by urine pregnancy test to confirm the situation for all women who are of 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 concerning to the investigator's clinical opinion.
  • * All contraindications for the medications that prevent subjects from randomization will be considered as exclusion criteria.
Management of Acute Tinnitus With Migraine Medications

Location Details

NCT06799169

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How to Participate

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Locations

RECRUITING

United States, California

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

Orange, California, United States, 92868