Summary

Eligibility
for people ages 25-85 (full criteria)
Location
at Orange, California
Dates
study started
estimated completion
Principal Investigator
Hamid R Djalilian, MD

Description

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.

Official Title

Treatment of Tinnitus With Migraine Medications: A Randomized Clinical Trial

Details

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.

Keywords

Tinnitus, Subjective Tinnitus medication randomized RCT trial migraine Migraine Disorders Topiramate Verapamil Paroxetine Nortriptyline Nortriptyline + topiramate Verapamil + paroxetine

Eligibility

You can join if…

Open to people ages 25-85

  • 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.

You CAN'T join if...

  • 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.

Location

  • University of California, Irvine Medical Center ENT Clinic (Pavilion 2) accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Hamid R Djalilian, MD
    Clinical Professor, Otolaryngology. Authored (or co-authored) 150 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT04404439
Phase
Phase 4
Study Type
Interventional
Last Updated