Treatment of Tinnitus With Migraine Medications

Phase

Condition

Oral Facial Pain

Migraine (Adult)

Tinnitus

Treatment

Placebo

Verapamil + Paroxetine

Nortriptyline + Topiramate

Clinical Study ID

NCT04404439

20184458

Ages 25-85
All Genders

Study 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. In addition, it contributes significant costs to the healthcare system. However, the mechanisms of tinnitus are poorly understood. and there is currently no FDA-approved medication to treat this condition. Current pharmacological treatment options address the stress, anxiety, and depression that are caused by tinnitus. There is an increased evidence of an epidemiological and mechanistic association between tinnitus and migraine. Therefore, in this study, we intended to evaluate the effectiveness of two combinations of migraine medications on patients with moderate to severe tinnitus by comparing them to placebo.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Pregnancy will result in automatic exclusion from the study. Rule out of pregnancywill be done by a urine pregnancy test to confirm the situation for all women whoare 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 tothe investigators clinical opinion.
All contraindications for the medications which prevent subjects from randomizationwill be considered as exclusion criteria.

Study Design

Placebo

September 26, 2019

December 30, 2023

Study Description

This is an 8-week double-blind, randomized (1:1:1), placebo controlled clinical trial, including adult participants with moderate to severe tinnitus (Tinnitus Functional Index (TFI) >25). After consenting, the participants will be randomized into one of the three arms: 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 (Microcrystalline Cellulose; PH105). The capsules are in same color and shape and will be supplied by the UCI medical center on-site pharmacy, each containing the initial dosage of medications. All 3 treatments groups might include dose escalation from initial dosage during the study. 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). Participants will be contacted by a blinded physician via telephone once per week and in-person visits will be scheduled for week 0, 4, and 8. If during these weekly contacts, the participant reports less than 20% improvement in tinnitus compared to the baseline Visual Analog Scale (VAS) obtained at the beginning of the trial, the physician will instruct the participant to increase the dosage for that week. Conversely, if a participant reports more than or equal to 20% improvement as compared to the baseline VAS, the team member will advise the participant to maintain the same dosage of medication for 1 week until the next weekly check-in. Furthermore, at the clinical assessment visits, participants will complete a tablet-based assessment of tinnitus symptoms. The questionnaire results will be securely transferred to a REDCap database. A data safety monitor will address any reported side effects throughout the study.

The within-arm analyses will be based on per-protocol estimand and tested with paired 2-tailed t tests. The between-arm analyses will be based on a per-protocol estimand and tested with analysis of variance (ANOVA) analysis. In addition, an intention-to-treat analysis will be also conducted with identical methods and analyses.

Connect with a study center

University of California, Irvine Medical Center ENT Clinic (Pavilion 2)
Orange, California 92868
United States
Site Not Available

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