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Tricyclic Antidepressant

Migraine Medications for Tinnitus

Orange, CA

Phase 4

Recruiting

Led By Mehdi Abouzari, MD, PhD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female between the ages of 25 to 85 years

Be older than 18 years old

Must not have

All contraindications for the medications that prevent subjects from randomization will be considered as 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

"This trial aims to study the use of medications to help patients with acute tinnitus manage the impact of the condition on their daily lives. Tinnitus is a common and distressing problem that can cause various

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Who is the study for?

This trial is for individuals experiencing acute tinnitus, which is a persistent ringing in the ears. Participants should not have any FDA-approved medication for their condition and are looking to reduce the impact of tinnitus on daily life. Details about specific inclusion or exclusion criteria were not provided.Check my eligibility

What is being tested?

The study tests if migraine medications (Verapamil, Nortriptyline, Paroxetine, Topiramate) can help manage acute tinnitus. It measures changes in the frequency and loudness of tinnitus before and after treatment using surveys and functional MRI scans.See study design

What are the potential side effects?

Potential side effects may include dizziness, dry mouth, weight changes, constipation from Nortriptyline; headaches or edema from Verapamil; fatigue or sexual dysfunction from Paroxetine; and weight loss or cognitive issues from Topiramate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 25 and 85 years old.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no health conditions that prevent me from taking certain medications.

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I am not pregnant, confirmed by a urine test.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tinnitus Functional Index

Secondary study objectives

Generalized Anxiety Disorder (GAD-7)

Patient Health Questionnaire (PHQ-9)

Perceived Stress Scale (PSS)

+3 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Group V-PActive Control2 Interventions

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).

Group II: Group N-TActive Control2 Interventions

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).

0 / 3Eligibility criteria met