Management of Acute Tinnitus With Migraine Medications

NCT06799169 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 4863
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tinnitus; Acute tinnitus; Atypical migraine; ringing in ears

Outcome Measures

Primary Outcomes (1)

• Tinnitus Functional Index

  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.

  8 weeks

Secondary Outcomes (6)

• Tinnitus Functional Index (TFI)

  8 weeks

• Perceived Stress Scale (PSS)

  8 weeks

• Patient Health Questionnaire (PHQ-9)

  8 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  8 weeks

• Generalized Anxiety Disorder (GAD-7)

  8 weeks

Study Arms (2)

Group N-T

ACTIVE COMPARATOR

Nortriptyline (starting dose 7.5 mg) plus Topiramate (starting dose 10 mg) with appropriate dosage increase as necessary. The reported symptoms will dictate dosage adjustments. If symptoms do not improve, patients will be advised to increase their dosage by adding one additional pill, which equals an increase of nortriptyline by 7.5 mg and topiramate by 10 mg for one week until the next phone check-in. This process will continue until the patient reaches a maximum of 60mg for nortriptyline plus 80mg for topiramate for the duration of the 8 weeks (a total of 8 pills of each combination).

Drug: Nortriptyline; Drug: Topiramate

Group V-P

ACTIVE COMPARATOR

Verapamil (starting dose 30 mg) plus Paroxetine (starting dose 4 mg) with appropriate dosage increase as necessary. The reported symptoms will dictate dosage adjustments. If symptoms do not improve, patients will be advised to increase their dosage by adding one additional pill, which equals an increase of verapamil by 30 mg and paroxetine by 4 mg, for one week until the next phone check-in. This process will continue until the patient reaches a maximum of 240mg of verapamil plus 32mg of paroxetine for the duration of the 8 weeks (a total of 8 pills of each combination).

Drug: Paroxetine; Drug: Verapamil

Interventions

Nortriptyline DRUG

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

Also known as: Pamelor

Group N-T

Topiramate DRUG

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

Also known as: Topamax

Group N-T

Paroxetine DRUG

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

Also known as: Paxil

Group V-P

Verapamil DRUG

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

Also known as: Calan SR

Group V-P

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

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

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Tinnitus; Migraine without Aura

Interventions

Nortriptyline; Topiramate; Paroxetine; Verapamil

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenethylamines; Ethylamines; Amines

Study Officials

• Mehdi Abouzari, MD, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The principal investigator, provider, lead researchers and the subjects will be masked throughout the duration of the clinical trial. Solely the clinical coordinator will be unmasked during the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor

Model Details: This study is an 8-week, randomized, double-blind, single-center clinical trial, consisting of two arms: Group N-T, a nortriptyline (7.5mg) plus topiramate (10mg) group and group V-P, a verapamil (30mg) plus paroxetine (4mg) group. Both groups may involve dose escalation from the initial dosage during the study.

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: January 29, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)