Treatment of Tinnitus With Migraine Medications
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
150 participants in 3 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Hamid R Djalilian, MD
Data sourced from clinicaltrials.gov
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