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Management of Acute Tinnitus With Migraine Medications

NCT06799169 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-10

No results posted yet for this 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. Despite too many research projects on finding the mechanism of tinnitus, its pathophysiology remains poorly understood. It is well understood that many factors, such as poor education, lower income, or occupational, and recreational activity associated with high noise exposure, influence 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, the investigators intend to use medications for patients with acute tinnitus to decrease the impact of tinnitus in their daily lives and activities. There are some studies on medications treating tinnitus; however, there are few randomized clinical trials to prove the efficacy of the treatment. The frequency and loudness of tinnitus will be measured before and after the course. Functional MRI of the brain will be obtained to view any changes that may occur before and after the treatment.

Conditions

  • Tinnitus

Interventions

DRUG

Nortriptyline

Nortriptyline (7.5 mg) plus Topiramate (10 mg) taken by mouth daily with appropriate dosage increase as necessary

DRUG

Topiramate

Nortriptyline (7.5 mg) plus Topiramate (10 mg) taken by mouth daily with appropriate dosage increase as necessary

DRUG

Paroxetine

Verapamil (30 mg) plus Paroxetine (4 mg) taken by mouth daily with appropriate dosage increase as necessary

DRUG

Verapamil

Verapamil (30 mg) plus Paroxetine (4 mg) taken by mouth daily with appropriate dosage increase as necessary

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Mehdi Abouzari, MD, PhD · University of California, Irvine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06799169 on ClinicalTrials.gov