TinnitusPhase 4NCT06799169
Management of Acute Tinnitus With Migraine Medications
A Phase 4 study testing Nortriptyline, Topiramate and Paroxetine in people with Tinnitus, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Nortriptyline, Topiramate and Paroxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to Dec 2030
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Medical Center ENT Clinic (Pavilion 2)
Orange, California, 92868
About this study
Official title: Management of Acute Tinnitus With Migraine Medications: A Randomized Clinical Trial
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.
Read the detailed description
This study is 8 weeks in duration. There are two arms in the experiment: the first is nortriptyline (starting dose 7.5 mg) plus topiramate (starting dose 10 mg), the second is verapamil (starting dose 30 mg) plus paroxetine (starting dose 4 mg). Doses may increase weekly if symptoms do not improve, up to a maximum of 60 mg nortriptyline plus 80 mg topiramate, or 240 mg verapamil plus 32 mg paroxetine. 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. 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 patients start to report changes in symptoms, in order to monitor patient safety and provide advice on change in dosage if patients have questions.
- Conditions
- Tinnitus
- Being tested
- Nortriptyline, Topiramate, Paroxetine, Verapamil
- Keywords
- Tinnitus, Acute tinnitus, Atypical migraine, ringing in ears
- Medical subject headings
- Tinnitus, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NortriptylineDrug
Also called Pamelor
Nortriptyline (7.5 mg) plus Topiramate (10 mg) taken by mouth daily with appropriate dosage increase as necessary
TopiramateDrug
Also called Topamax
Nortriptyline (7.5 mg) plus Topiramate (10 mg) taken by mouth daily with appropriate dosage increase as necessary
ParoxetineDrug
Also called Paxil
Verapamil (30 mg) plus Paroxetine (4 mg) taken by mouth daily with appropriate dosage increase as necessary
VerapamilDrug
Also called Calan SR
Verapamil (30 mg) plus Paroxetine (4 mg) taken by mouth daily with appropriate dosage increase as necessary
| Study group | Role | What they receive |
|---|---|---|
| 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 the 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 60 mg for nortriptyline plus 80 mg for topiramate for the duration of the 8 weeks (a total of 8 pills of each combination). Receives: 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 the 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 240 mg of verapamil plus 32 mg of paroxetine for the duration of the 8 weeks (a total of 8 pills of each combination). Receives: Drug: Paroxetine; Drug: Verapamil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (6)
Tinnitus Functional Index (TFI)
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.
Measured: 8 weeks
Perceived Stress Scale (PSS)
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.
Measured: 8 weeks
Patient Health Questionnaire (PHQ-9)
Subjective improvement in depression symptoms based on Patient Health Questionnaire (PHQ). The PHQ is scored from 0 to 27, with higher scores indicating greater depression severity.
Measured: 8 weeks
Pittsburgh Sleep Quality Index (PSQI)
Subjective improvement in sleep quality based on the Pittsburgh Sleep Quality Index (PSQI). The PSQI is scored from 0 to 21, with higher scores indicating worse sleep quality.
Measured: 8 weeks
Generalized Anxiety Disorder (GAD-7)
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 greater anxiety severity.
Measured: 8 weeks
Visual Analog Scale (VAS)
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 greater severity of tinnitus.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Jun 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Why it stopped: Enrollment temporarily paused pending IRB continuing review; recruitment expected to resume.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is an 8 week, randomized, double-blind, single-center clinical trial, consisting of two arms: Group N-T, a nortriptyline (7.5 mg) plus topiramate (10 mg) group and group V-P, a verapamil (30 mg) plus paroxetine (4 mg) group. Both groups may involve dose escalation from the initial dosage during the study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Abouzari, University of California, Irvine
- Investigators
- Mehdi Abouzari, MD, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799169
- Sponsor's protocol ID
- 4863
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Final study results will not be shared with subjects. Upon the final appointment patient will be told of which medication they have been given. It will not be necessary to share the final results since the patient will know if their symptoms have improved- no lab value can be given to measure this. Since this study will be listed on clinicaltrials.gov, the overall study results will be available through that platform after the completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Acute Tinnitus With Migraine Medications: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06799169
- Acronym / sponsor ID
- 4863
- Conditions
- Tinnitus
- Keywords
- Tinnitus, Acute tinnitus, Atypical migraine, ringing in ears
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Enrollment temporarily paused pending IRB continuing review; recruitment expected to resume.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is 8 weeks in duration. There are two arms in the experiment: the first is nortriptyline (starting dose 7.5 mg) plus topiramate (starting dose 10 mg), the second is verapamil (starting dose 30 mg) plus paroxetine (starting dose 4 mg). Doses may increase weekly if symptoms do not improve, up to a maximum of 60 mg nortriptyline plus 80 mg topiramate, or 240 mg verapamil plus 32 mg paroxetine. 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. 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 patients start to report changes in symptoms, in order to monitor patient safety and provide advice on change in dosage if patients have questions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study is an 8 week, randomized, double-blind, single-center clinical trial, consisting of two arms: Group N-T, a nortriptyline (7.5 mg) plus topiramate (10 mg) group and group V-P, a verapamil (30 mg) plus paroxetine (4 mg) group. Both groups may involve dose escalation from the initial dosage during the study.
| Arm | Type | Receives |
|---|---|---|
| Group N-T | Active comparator | Drug: Nortriptyline, Drug: TopiramateNortriptyline (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 the 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 60 mg for nortriptyline plus 80 mg for topiramate for the duration of the 8 weeks (a total of 8 pills of each combination). |
| Group V-P | Active comparator | Drug: Paroxetine, Drug: VerapamilVerapamil (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 the 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 240 mg of verapamil plus 32 mg of paroxetine for the duration of the 8 weeks (a total of 8 pills of each combination). |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NortriptylineAlso: PamelorNortriptyline (7.5 mg) plus Topiramate (10 mg) taken by mouth daily with appropriate dosage increase as necessary | Drug | Group N-T |
| TopiramateAlso: TopamaxNortriptyline (7.5 mg) plus Topiramate (10 mg) taken by mouth daily with appropriate dosage increase as necessary | Drug | Group N-T |
| ParoxetineAlso: PaxilVerapamil (30 mg) plus Paroxetine (4 mg) taken by mouth daily with appropriate dosage increase as necessary | Drug | Group V-P |
| VerapamilAlso: Calan SRVerapamil (30 mg) plus Paroxetine (4 mg) taken by mouth daily with appropriate dosage increase as necessary | Drug | Group V-P |
Primary outcome
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.
6 secondary outcomes
Tinnitus Functional Index (TFI)
Time frame: 8 weeks
Perceived Stress Scale (PSS)
Time frame: 8 weeks
Patient Health Questionnaire (PHQ-9)
Time frame: 8 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 8 weeks
Generalized Anxiety Disorder (GAD-7)
Time frame: 8 weeks
Visual Analog Scale (VAS)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. Final study results will not be shared with subjects. Upon the final appointment patient will be told of which medication they have been given. It will not be necessary to share the final results since the patient will know if their symptoms have improved- no lab value can be given to measure this. Since this study will be listed on clinicaltrials.gov, the overall study results will be available through that platform after the completion of the study.
Related trials for Tinnitus
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A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
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Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
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Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
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Enrolling by invitationObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehdi Abouzari, MD, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nortriptyline, Topiramate and Paroxetine in people with Tinnitus, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Functional Index (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.