Clinical trial NCT04404439: Treatment of Tinnitus With Migraine Medications
Official title: Treatment of Tinnitus With Migraine Medications: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tinnitus, Subjective
Tinnitus
Keywords: tinnitus
medication
randomized
RCT
trial
migraine
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to a study group by chance (like a coin flip) rather than by a medical decision made by the researchers. There are three arms in the study (treatment group 1 which consists of nortriptyline + topiramate, treatment group 2 which consist of verapamil + paroxetine, and a placebo group), and participants enrolling in the trial will be randomly assigned in a 1:1:1 fashion to one of the arms. The participant will remain in the same arm for the duration of the study (8 weeks). There may be multiple participants in each arm who are undergoing the study at the same time (parallel model).
Primary purpose: TREATMENT

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. 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tinnitus Functional Index (TFI)
timeFrame: 8 weeks
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 8 weeks
measure: Patient Health Questionnaire (PHQ)
timeFrame: 8 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: 8 weeks
measure: Sleep Quality Index (SQI)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center ENT Clinic (Pavilion 2)
state: California
Study officials:
affiliation: Univeristy of California, Irvine
name: Hamid R Djalilian, MD
role: PRINCIPAL_INVESTIGATOR
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