Phase 4
N=78
Treatment of Tinnitus With Migraine Medications
Tinnitus, Subjective · Tinnitus
Bottom Line
View on ClinicalTrials.gov: NCT04404439 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Tinnitus Functional Index (TFI) — -12.1; -12.4; -6.0 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nortriptyline + Topiramate (Drug); Verapamil + Paroxetine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tinnitus Functional Index (TFI) |
-12.1; -12.4; -6.0 | — |
| SECONDARY Patient Health Questionnaire (PHQ) |
-3.1; -0.6; -0.7 | — |
| SECONDARY Perceived Stress Scale (PSS) |
-3.0; -2.0; 0.5 | — |
| SECONDARY Pittsburgh Sleep Quality Index (SQI) |
0.3; -0.6; 0.1 | — |
| SECONDARY Generalized Anxiety Disorder (GAD-7) |
-2.5; -2.7; 0.04 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT04404439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.