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Tricyclic Antidepressant + Anticonvulsant
Migraine Medications for Tinnitus
Phase 4
Recruiting
Led By Hamid R Djalilian, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial is testing whether using medications can help decrease the negative impact that tinnitus has on patients' daily lives.
Who is the study for?
This trial is for adults aged 25-85 with moderate to severe tinnitus. Participants must be able to read and write English, attend study visits, and comply with medication regimens. Pregnant individuals, those with adverse reactions to the medications being tested or certain medical conditions are excluded.Check my eligibility
What is being tested?
The trial tests if migraine medications can help treat tinnitus. It compares the effectiveness of Nortriptyline plus Topiramate versus Verapamil plus Paroxetine against a placebo in reducing the impact of tinnitus on daily life.See study design
What are the potential side effects?
Potential side effects may include dry mouth, constipation, weight changes from Nortriptyline; numbness or tingling from Topiramate; low blood pressure or dizziness from Verapamil; and nausea or sleep disturbances from Paroxetine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
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 moreTrial 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
542 Previous Clinical Trials
1,921,851 Total Patients Enrolled
3 Trials studying Tinnitus
223 Patients Enrolled for Tinnitus
Hamid R Djalilian, MDPrincipal InvestigatorUniveristy of California, Irvine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a bad reaction to the medication before.You have moderate to severe ringing in your ears.You are between 25 and 85 years old.You have ongoing, bothersome ringing or buzzing in your ears.You are between 25 and 85 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Verapamil + paroxetine
- Group 2: Nortriptyline + topiramate
- Group 3: Placebo
Awards:
This trial has 4 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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?
Georgia
Texas
Other
California
How old are they?
65+
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?
1
2
3+
0
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?
Most responsive sites:
- University of California, Irvine Medical Center ENT Clinic (Pavilion 2): < 48 hours
Average response time
- < 2 Days
Typically responds via
Email
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