CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 78 enrolled
Drug / intervention
Nortriptyline + Topiramate +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04404439
NCT04404439Phase 4Completed

Treatment of Tinnitus With Migraine Medications: A Randomized Clinical Trial

University of California, Irvine·interventional·Posted May 27, 2020·Updated Apr 16, 2026

In Brief

A Phase 4 clinical trial evaluating Nortriptyline + Topiramate, Verapamil + Paroxetine, and 1 other intervention for Tinnitus, Subjective and Tinnitus. Completed, enrolled 78 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedMay 27, 2020
Enrollment StartSep 26, 2019
Primary CompletionDec 30, 2023
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 6.1 years ago

Interventions

Nortriptyline + Topiramatedrug

Group NT

Verapamil + Paroxetinedrug

Group VP

Placebodrug

Group P