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Active, Not Recruiting

NCT Number: NCT06799169

Management of Acute Tinnitus With Migraine Medications

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tinnitus Brain Diseases Central Nervous System Diseases Ear Diseases Headache Disorders Headache Disorders, Primary Hearing Disorders Migraine Disorders Migraine without Aura Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

25 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, Irvine Medical Center ENT Clinic (Pavilion 2)

Orange, California, 92868, United States

About this study

This study is 8-weeks in duration. There are two arms in the experiment: the first is nortriptyline (7.5 mg) plus topiramate (10 mg), the second is verapamil (240 mg) plus paroxetine (32 mg). This is a double-blinded trial. Participants will be randomized to one arm for the duration of the trial using simple randomization with a computer-generated number. Both groups may receive dosage increases weekly if symptoms do not improve. Symptomatic survey scores from each arm will be obtained before and after treatment and weekly. An unblinded clinical researcher will also become involved with patients' treatments as they start to report changes in symptoms in order to monitor their safety and provide advice on change in dosage if patients have questions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with mild to moderate tinnitus.
  • Male or female between the ages of 25 to 85 years.
  • Subjects must be compliant with the medication and attend study visits.
  • Must be able to read and write in the English language to provide consent.

Exclusion criteria

  • Pregnancy will result in automatic exclusion from the study. Rule out of pregnancy will be done by urine pregnancy test to confirm the situation for all women who are of childbearing potential.
  • Subjects with a history of an adverse reaction to medication being prescribed.
  • Subjects suffering from a medical condition or have a history that may be concerning to the investigator's clinical opinion.
  • All contraindications for the medications that prevent subjects from randomization will be considered as exclusion criteria.

Treatment and study plan

Nortriptyline

Drug

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

Other names: Pamelor

Topiramate

Drug

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

Other names: Topamax

paroxetine

Drug

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

Other names: Paxil

Verapamil

Drug

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

Other names: Calan SR

Primary outcomes

  1. Tinnitus Functional Index

    Time frame: 8 weeks

    The primary outcome endpoint is a Tinnitus Functional Index (TFI) score which comprehensively evaluates the negative impact of tinnitus across 8 domains each focusing on specific dimensions: Intrusive, Sense of control, Cognitive, Sleep, Auditory, Relaxation, Quality of life, and Emotional. The overall score ranges from 0 to 100. Changes 13 points in TFI are the Minimal Clinically Important Difference (MCID). Subjective improvement from baseline in tinnitus symptoms as measured by Tinnitus Functional Index (TFI). The TFI is scored from 0% to 100%, with higher scores indicating a more negative impact of tinnitus.

Secondary outcomes

  1. Tinnitus Functional Index (TFI)

    Time frame: 8 weeks

    Subjective improvement from baseline in tinnitus symptoms as measured by Tinnitus Functional Index (TFI). The TFI is scored from 0% to 100%, with higher scores indicating a more negative impact of tinnitus.

  2. Perceived Stress Scale (PSS)

    Time frame: 8 weeks

    Perceived Stress Scale (PSS) [Time Frame: 8 weeks] Subjective improvement in stress based on perceived stress scale (PSS). The PSS is scored from 0 to 40, with higher scores indicating higher perceived stress.

  3. Patient Health Questionnaire (PHQ-9)

    Time frame: 8 weeks

    Subjective improvement in depression symptoms based on patient health questionnaire (PHQ). The PHQ is scored from 0 to 27, with a higher score indicating increased depression severity.

  4. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 8 weeks

    Subjective improvement in sleep quality based on sleep quality index (PSQI). The PSQI is scored from 0 to 21, with higher scores indicating worse quality of sleep.

  5. Generalized Anxiety Disorder (GAD-7)

    Time frame: 8 weeks

    Subjective improvement in generalized anxiety based on general anxiety disorder (GAD-7). The GAD-7 is scored from 0 to 21, with higher scores indicating increased anxiety severity.

  6. Visual Analog Scale (VAS)

    Time frame: 8 weeks

    Subjective improvement in tinnitus loudness severity based on a visual analog scale (VAS). The VAS is scored from 0 to 10, with a higher score representing an increased severity of tinnitus.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Management of Acute Tinnitus With Migraine Medications: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2025
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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