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Tricyclic Antidepressant + Anticonvulsant

Migraine Medications for Tinnitus

University of California, Irvine Medical Center ENT Clinic (Pavilion 2), Orange, CA
Targeting 2 different conditionsNortriptyline + topiramate +2 morePhase 4RecruitingLed by Hamid R Djalilian, MDResearch Sponsored by University of California, Irvine

Study Summary

This trial is testing whether using medications can help decrease the negative impact that tinnitus has on patients' daily lives.

Eligible Conditions
  • Tinnitus

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have moderate to severe ringing in your ears.
You are between 25 and 85 years old.


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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tinnitus Functional Index (TFI)
Secondary outcome measures
Patient Health Questionnaire (PHQ)
Perceived Stress Scale (PSS)
Sleep Quality Index (SQI)
+1 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Verapamil + paroxetineExperimental Treatment1 Intervention
Verapamil (30 mg) plus paroxetine (4 mg) in a single pill initially taken once daily. Dose may be increased as directed by care provider by 30mg weekly (to a maximum of 240mg) for verapamil, and by 4mg weekly (maximum 32mg) for paroxetine.
Group II: Nortriptyline + topiramateExperimental Treatment1 Intervention
Nortriptyline (7.5 mg) plus topiramate (10 mg) in a single pill initially taken once daily. Dose may be increased as directed by care provider by 7.5mg weekly (to a maximum of 60mg) for nortriptyline, and by 10mg weekly (maximum 80mg) for topiramate.
Group III: PlaceboPlacebo Group1 Intervention
Placebo pill.

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
528 Previous Clinical Trials
1,889,554 Total Patients Enrolled
3 Trials studying Tinnitus
223 Patients Enrolled for Tinnitus
Hamid R Djalilian, MDPrincipal InvestigatorUniveristy of California, Irvine

Media Library

Nortriptyline + Topiramate (Tricyclic Antidepressant + Anticonvulsant) Clinical Trial Eligibility Overview. Trial Name: NCT04404439 — Phase 4
Tinnitus Research Study Groups: Verapamil + paroxetine, Nortriptyline + topiramate, Placebo
Tinnitus Clinical Trial 2023: Nortriptyline + Topiramate Highlights & Side Effects. Trial Name: NCT04404439 — Phase 4
Nortriptyline + Topiramate (Tricyclic Antidepressant + Anticonvulsant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04404439 — Phase 4
Tinnitus Patient Testimony for trial: Trial Name: NCT04404439 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
How old are they?
18 - 65
What site did they apply to?
University of California, Irvine Medical Center ENT Clinic (Pavilion 2)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

I want to stop the ringing in my ears. Significant ringing and looking for relief.
PatientReceived 2+ prior treatments
I have tried multiple drugs with zero benefit. I have had tinnitus for many years and it continues to worsen.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long do these screenings take? How many visits are required. Might screening be performed via zoom or similar?
PatientReceived 1 prior treatment
How many visits to Orange will be required to complete the study? Has the study shown success in the first three phases?
PatientReceived 2+ prior treatments
Unfortunately we are based in Malaysia. Any chances to have counterparts in Malaysia or Singapore for an evaluation for us to qualify?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Average response time
  • < 2 Days
Most responsive sites:
  1. University of California, Irvine Medical Center ENT Clinic (Pavilion 2): < 48 hours
~0 spots leftby Dec 2023