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Treatment of Tinnitus With Migraine Medications

NCT04404439 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-04-16

Study results available
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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.

Conditions

  • Tinnitus, Subjective
  • Tinnitus

Interventions

DRUG

Nortriptyline + Topiramate

Group NT

DRUG

Verapamil + Paroxetine

Group VP

DRUG

Placebo

Group P

Sponsors & Collaborators

  • Otolaryngology Medical Clinic,University of California, Irvine

    collaborator OTHER

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Hamid R Djalilian, MD · Univeristy of California, Irvine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2023-12-30
Completion
2023-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04404439 on ClinicalTrials.gov