Treatment of Tinnitus With Migraine Medications

Phase 4

Recruiting

• Conditions: Tinnitus; Tinnitus, Subjective
• Interventions: Drug: Verapamil + paroxetine; Other: Placebo; Drug: Nortriptyline + topiramate

• Registration Number: NCT04404439
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study Start: 2019-09-26
• Study First Submitted: 2020-05-17
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-27
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-06
• Last Update Posted: 2023-01-09
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verapamil + paroxetine	Verapamil + paroxetine	Verapamil (30 mg) plus paroxetine (4 mg) in a single pill initially taken once daily. Dose may be increased as directed by care provider by 30mg weekly (to a maximum of 240mg) for verapamil, and by 4mg weekly (maximum 32mg) for paroxetine.
Placebo	Placebo	Placebo pill.
Nortriptyline + topiramate	Nortriptyline + topiramate	Nortriptyline (7.5 mg) plus topiramate (10 mg) in a single pill initially taken once daily. Dose may be increased as directed by care provider by 7.5mg weekly (to a maximum of 60mg) for nortriptyline, and by 10mg weekly (maximum 80mg) for topiramate.

Primary Outcome Measures

Name	Time	Method
Tinnitus Functional Index (TFI)	8 weeks	Subjective improvement from baseline in tinnitus symptoms as measured by Tinnitus Functional Index (TFI). The TFI is scored from 0% to 100%, with higher scores indicating a more negative impact of tinnitus.

Secondary Outcome Measures

Name	Time	Method
Sleep Quality Index (SQI)	8 weeks	Subjective improvement in sleep quality based on sleep quality index (SQI). The SQI is scored from 0 to 21, with higher scores indicating worse quality of sleep.
Visual Analog Scale (VAS)	8 weeks	Subjective improvement in tinnitus loudness severity based on a visual analog scale (VAS). The VAS is scored from 0 to 10, with a higher score representing an increased severity of tinnitus.
Patient Health Questionnaire (PHQ)	8 weeks	Subjective improvement in depression symptoms based on patient health questionnaire (PHQ). The PHQ is scored from 0 to 27, with a higher score indicating increased depression severity.
Perceived Stress Scale (PSS)	8 weeks	Subjective improvement in stress based on perceived stress scale (PSS). The PSS is scored from 0 to 40, with higher scores indicating higher perceived stress.

Trial Locations

Locations (1)

University of California, Irvine Medical Center ENT Clinic (Pavilion 2); 🇺🇸 Orange, California, United States