Tinnitus, SubjectivePhase 4NCT04404439
Treatment of Tinnitus With Migraine Medications
A Phase 4 study testing Nortriptyline + Topiramate and Verapamil + Paroxetine in people with Tinnitus, Subjective and 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. In addition, it contributes significant costs to the healthcare system. However, the mechanisms of tinnitus are poorly understood. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Tinnitus, Subjective, Tinnitus
- What is being tested?
- Nortriptyline + Topiramate and Verapamil + Paroxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2019to 30 Dec 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 moderate to severe tinnitus.
- Male or female between the ages of 25 to 85 years.
- Subject must be compliant with the medication and attend study visits.
- Must be able to read and write in the English language to provide consenting.
Who cannot join
- Pregnancy will result in automatic exclusion from the study. Rule out of pregnancy will be done by a urine pregnancy test to confirm the situation for all women who are of child bearing potential.
- Subject with history of an adverse reaction to medication being prescribed.
- Subject suffers from a medical condition or has history that may be concerning to the investigators clinical opinion.
- All contraindications for the medications which 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: Treatment of 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. In addition, it contributes significant costs to the healthcare system. However, the mechanisms of tinnitus are poorly understood. and there is currently no FDA-approved medication to treat this condition. Current pharmacological treatment options address the stress, anxiety, and depression that are caused by tinnitus. There is an increased evidence of an epidemiological and mechanistic association between tinnitus and migraine. Therefore, in this study, we intended to evaluate the effectiveness of two combinations of migraine medications on patients with moderate to severe tinnitus by comparing them to placebo.
Read the detailed description
This is an 8-week double-blind, randomized (1:1:1), placebo controlled clinical trial, including adult participants with moderate to severe tinnitus (Tinnitus Functional Index (TFI) >25). After consenting, the participants will be randomized into one of the three arms: the first is nortriptyline (7.5 mg) plus topiramate (10 mg), the second is verapamil (30 mg) plus paroxetine (4 mg), and the third is a placebo group (Microcrystalline Cellulose; PH105). The capsules are in same color and shape and will be supplied by the UCI medical center on-site pharmacy, each containing the initial dosage of medications. All 3 treatments groups might include dose escalation from initial dosage during the study. Nortriptyline may be increased by 7.5mg weekly (to a maximum of 60mg), topiramate by 10mg weekly (maximum 80mg), verapamil by 30mg weekly (maximum 240mg), and paroxetine by 4mg weekly (maximum 32mg). Participants will be contacted by a blinded physician via telephone once per week and in-person visits will be scheduled for week 0, 4, and 8. If during these weekly contacts, the participant reports less than 20% improvement in tinnitus compared to the baseline Visual Analog Scale (VAS) obtained at the beginning of the trial, the physician will instruct the participant to increase the dosage for that week. Conversely, if a participant reports more than or equal to 20% improvement as compared to the baseline VAS, the team member will advise the participant to maintain the same dosage of medication for 1 week until the next weekly check-in. Furthermore, at the clinical assessment visits, participants will complete a tablet-based assessment of tinnitus symptoms. The questionnaire results will be securely transferred to a REDCap database. A data safety monitor will address any reported side effects throughout the study.
The within-arm analyses will be based on per-protocol estimand and tested with paired 2-tailed t tests. The between-arm analyses will be based on a per-protocol estimand and tested with analysis of variance (ANOVA) analysis. In addition, an intention-to-treat analysis will be also conducted with identical methods and analyses.
- Conditions
- Tinnitus, Subjective, Tinnitus
- Being tested
- Nortriptyline + Topiramate, Verapamil + Paroxetine, Placebo
- Keywords
- tinnitus, medication, randomized, trial, migraine, clinical
- Medical subject headings
- Tinnitus, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nortriptyline + TopiramateDrug
Group NT
Verapamil + ParoxetineDrug
Group VP
PlaceboDrug
Group P
| Study group | Role | What they receive |
|---|---|---|
| Nortriptyline + Topiramate | Experimental | Nortriptyline (7.5 mg) plus topiramate (10 mg) 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. Receives: Drug: Nortriptyline + Topiramate |
| Verapamil + Paroxetine | Experimental | Verapamil (30 mg) plus paroxetine (4 mg) 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. Receives: Drug: Verapamil + Paroxetine |
| Placebo | Placebo comparator | Placebo pill (Microcrystalline Cellulose; PH105) taken once daily. Dose may be increased as directed by care provider. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Functional Index (TFI)
The TFI is a 25 item questionnaire rated on a 0 to 10 scale evaluating the negative impact of tinnitus across 8 domains: Intrusive, Sense of control, Cognitive, Sleep, Auditory, Relaxation, Quality of life, and Emotional. A 0 score indicates low to no impact where a 10 would indicate distress or great impact. The overall TFI score is calculated by dividing the sum of the responses (max possible 250) by the number of responses to get the mean, then multiplying the mean by 10 to obtain the overall TFI score. Overall TFI score can range from 0 to 100. Scores > 31 indicate tinnitus is a moderate to significant problem. A reduction of 13 points in TFI is considered the Minimal Clinically Important Difference (MCID).
Measured: Baseline and 8 weeks (end of trial)
Secondary outcomes (4)
Patient Health Questionnaire (PHQ)
Change in depression symptoms based on the Patient Health Questionnaire-9 (PHQ-9), scored from 0 to 27. Higher scores indicate greater symptom severity. A negative change reflects improvement. Mean changes from baseline to Week 8 were analyzed using paired t-tests (per-protocol). A ≥5-point improvement was considered the minimal clinically important difference (MCID).
Measured: Baseline and 8 weeks
Perceived Stress Scale (PSS)
Change in perceived stress symptoms based on the Perceived Stress Scale (PSS), scored from 0 to 40. The PSS is a 10 question Likert-type scale with answers ranging from (0) "Never" to (4) "Very often". Four questions with positive statements are scored in reverse (0 = 4, 1 = 3, 2 = 2, 3 = 1, 4 = 0). Higher scores indicate greater stress. A negative change reflects improvement. Mean changes from baseline to Week 8 were analyzed using paired t-tests (per-protocol). A ≥11-point improvement was considered the minimal clinically important difference (MCID).
Measured: Baseline and 8 weeks
Pittsburgh Sleep Quality Index (SQI)
Change in sleep quality based on the Pittsburgh Sleep Quality Index (PSQI), scored from 0 to 21. Higher scores indicate poorer sleep quality. A negative change reflects improvement. Mean changes from baseline to Week 8 were analyzed using paired 2-tailed t-tests (per-protocol). Standard error was calculated using end-of-trial SD and sample size. A ≥3-point improvement was considered the minimal clinically important difference (MCID).
Measured: Baseline and 8 weeks
Generalized Anxiety Disorder (GAD-7)
Change in anxiety symptoms based on the Generalized Anxiety Disorder-7 (GAD-7) scale, scored from 0 to 21. Higher scores indicate greater anxiety. A negative change reflects improvement. Mean changes from baseline to Week 8 were analyzed using paired 2-tailed t-tests (per-protocol). Standard error was calculated using end-of-trial SD and sample size. A ≥4-point improvement was considered the minimal clinically important difference (MCID).
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start26 Sep 2019
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Tinnitus, SubjectiveStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Otolaryngology Medical Clinic,University of California, Irvine
- Responsible party
- Principal investigator, Hamid Djalilian, University of California, Irvine
- Investigators
- Hamid R Djalilian, MD, Principal investigator, Univeristy of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404439
- Sponsor's protocol ID
- 20184458
- Status last verified
- Mar 2026
- First submitted
- 17 May 2020
- Last updated
- 16 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Evans RW, Ishiyama G. Migraine with transient unilateral hearing loss and tinnitus. Headache. 2009 May;49(5):756-8. doi: 10.1111/j.1526-4610.2008.01075.x. No abstract available.
PubMed 19472451Sindhusake D, Golding M, Newall P, Rubin G, Jakobsen K, Mitchell P. Risk factors for tinnitus in a population of older adults: the blue mountains hearing study. Ear Hear. 2003 Dec;24(6):501-7. doi: 10.1097/01.AUD.0000100204.08771.3D.
PubMed 14663349Dobie RA. A review of randomized clinical trials in tinnitus. Laryngoscope. 1999 Aug;109(8):1202-11. doi: 10.1097/00005537-199908000-00004.
PubMed 10443820Langguth B, Hund V, Busch V, Jurgens TP, Lainez JM, Landgrebe M, Schecklmann M. Tinnitus and Headache. Biomed Res Int. 2015;2015:797416. doi: 10.1155/2015/797416. Epub 2015 Oct 25.
PubMed 26583133Langguth B, Hund V, Landgrebe M, Schecklmann M. Tinnitus Patients with Comorbid Headaches: The Influence of Headache Type and Laterality on Tinnitus Characteristics. Front Neurol. 2017 Aug 28;8:440. doi: 10.3389/fneur.2017.00440. eCollection 2017.
PubMed 28894434Guichard E, Montagni I, Tzourio C, Kurth T. Association Between Headaches and Tinnitus in Young Adults: Cross-Sectional Study. Headache. 2016 Jun;56(6):987-94. doi: 10.1111/head.12845. Epub 2016 May 20.
PubMed 27197786Duckert LG, Rees TS. Treatment of tinnitus with intravenous lidocaine: a double-blind randomized trial. Otolaryngol Head Neck Surg. 1983 Oct;91(5):550-5. doi: 10.1177/019459988309100514.
PubMed 6417606Hallam RS, McKenna L, Shurlock L. Tinnitus impairs cognitive efficiency. Int J Audiol. 2004 Apr;43(4):218-26. doi: 10.1080/14992020400050030.
PubMed 15250126Muhlau M, Rauschecker JP, Oestreicher E, Gaser C, Rottinger M, Wohlschlager AM, Simon F, Etgen T, Conrad B, Sander D. Structural brain changes in tinnitus. Cereb Cortex. 2006 Sep;16(9):1283-8. doi: 10.1093/cercor/bhj070. Epub 2005 Nov 9.
PubMed 16280464Landgrebe M, Langguth B, Rosengarth K, Braun S, Koch A, Kleinjung T, May A, de Ridder D, Hajak G. Structural brain changes in tinnitus: grey matter decrease in auditory and non-auditory brain areas. Neuroimage. 2009 May 15;46(1):213-8. doi: 10.1016/j.neuroimage.2009.01.069. Epub 2009 Feb 12.
PubMed 19413945Price JL, Drevets WC. Neurocircuitry of mood disorders. Neuropsychopharmacology. 2010 Jan;35(1):192-216. doi: 10.1038/npp.2009.104.
PubMed 19693001Ploghaus A, Tracey I, Gati JS, Clare S, Menon RS, Matthews PM, Rawlins JN. Dissociating pain from its anticipation in the human brain. Science. 1999 Jun 18;284(5422):1979-81. doi: 10.1126/science.284.5422.1979.
PubMed 10373114Wager TD, Rilling JK, Smith EE, Sokolik A, Casey KL, Davidson RJ, Kosslyn SM, Rose RM, Cohen JD. Placebo-induced changes in FMRI in the anticipation and experience of pain. Science. 2004 Feb 20;303(5661):1162-7. doi: 10.1126/science.1093065.
PubMed 14976306Roberts LE, Eggermont JJ, Caspary DM, Shore SE, Melcher JR, Kaltenbach JA. Ringing ears: the neuroscience of tinnitus. J Neurosci. 2010 Nov 10;30(45):14972-9. doi: 10.1523/JNEUROSCI.4028-10.2010.
PubMed 21068300Minen MT, Camprodon J, Nehme R, Chemali Z. The neuropsychiatry of tinnitus: a circuit-based approach to the causes and treatments available. J Neurol Neurosurg Psychiatry. 2014 Oct;85(10):1138-44. doi: 10.1136/jnnp-2013-307339. Epub 2014 Apr 17.
PubMed 24744443
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Tinnitus With Migraine Medications: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04404439
- Acronym / sponsor ID
- 20184458
- Conditions
- Tinnitus, Subjective, Tinnitus
- Keywords
- tinnitus, medication, randomized, trial, migraine, clinical
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Otolaryngology Medical Clinic,University of California, Irvine
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Posted 16 Apr 2026
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. In addition, it contributes significant costs to the healthcare system. However, the mechanisms of tinnitus are poorly understood. and there is currently no FDA-approved medication to treat this condition. Current pharmacological treatment options address the stress, anxiety, and depression that are caused by tinnitus. There is an increased evidence of an epidemiological and mechanistic association between tinnitus and migraine. Therefore, in this study, we intended to evaluate the effectiveness of two combinations of migraine medications on patients with moderate to severe tinnitus by comparing them to placebo.
Detailed description
This is an 8-week double-blind, randomized (1:1:1), placebo controlled clinical trial, including adult participants with moderate to severe tinnitus (Tinnitus Functional Index (TFI) >25). After consenting, the participants will be randomized into one of the three arms: the first is nortriptyline (7.5 mg) plus topiramate (10 mg), the second is verapamil (30 mg) plus paroxetine (4 mg), and the third is a placebo group (Microcrystalline Cellulose; PH105). The capsules are in same color and shape and will be supplied by the UCI medical center on-site pharmacy, each containing the initial dosage of medications. All 3 treatments groups might include dose escalation from initial dosage during the study. Nortriptyline may be increased by 7.5mg weekly (to a maximum of 60mg), topiramate by 10mg weekly (maximum 80mg), verapamil by 30mg weekly (maximum 240mg), and paroxetine by 4mg weekly (maximum 32mg). Participants will be contacted by a blinded physician via telephone once per week and in-person visits will be scheduled for week 0, 4, and 8. If during these weekly contacts, the participant reports less than 20% improvement in tinnitus compared to the baseline Visual Analog Scale (VAS) obtained at the beginning of the trial, the physician will instruct the participant to increase the dosage for that week. Conversely, if a participant reports more than or equal to 20% improvement as compared to the baseline VAS, the team member will advise the participant to maintain the same dosage of medication for 1 week until the next weekly check-in. Furthermore, at the clinical assessment visits, participants will complete a tablet-based assessment of tinnitus symptoms. The questionnaire results will be securely transferred to a REDCap database. A data safety monitor will address any reported side effects throughout the study.
The within-arm analyses will be based on per-protocol estimand and tested with paired 2-tailed t tests. The between-arm analyses will be based on a per-protocol estimand and tested with analysis of variance (ANOVA) analysis. In addition, an intention-to-treat analysis will be also conducted with identical methods and analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nortriptyline + Topiramate | Experimental | Drug: Nortriptyline + TopiramateNortriptyline (7.5 mg) plus topiramate (10 mg) 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. |
| Verapamil + Paroxetine | Experimental | Drug: Verapamil + ParoxetineVerapamil (30 mg) plus paroxetine (4 mg) 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. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo pill (Microcrystalline Cellulose; PH105) taken once daily. Dose may be increased as directed by care provider. |
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 moderate to severe tinnitus.
- Male or female between the ages of 25 to 85 years.
- Subject must be compliant with the medication and attend study visits.
- Must be able to read and write in the English language to provide consenting.
Key exclusion criteria (4 listed)
- Pregnancy will result in automatic exclusion from the study. Rule out of pregnancy will be done by a urine pregnancy test to confirm the situation for all women who are of child bearing potential.
- Subject with history of an adverse reaction to medication being prescribed.
- Subject suffers from a medical condition or has history that may be concerning to the investigators clinical opinion.
- All contraindications for the medications which 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 |
|---|---|---|
| Nortriptyline + TopiramateGroup NT | Drug | Nortriptyline + Topiramate |
| Verapamil + ParoxetineGroup VP | Drug | Verapamil + Paroxetine |
| PlaceboGroup P | Drug | Placebo |
Primary outcome
Tinnitus Functional Index (TFI)
Time frame: Baseline and 8 weeks (end of trial)
The TFI is a 25 item questionnaire rated on a 0 to 10 scale evaluating the negative impact of tinnitus across 8 domains: Intrusive, Sense of control, Cognitive, Sleep, Auditory, Relaxation, Quality of life, and Emotional. A 0 score indicates low to no impact where a 10 would indicate distress or great impact. The overall TFI score is calculated by dividing the sum of the responses (max possible 250) by the number of responses to get the mean, then multiplying the mean by 10 to obtain the overall TFI score. Overall TFI score can range from 0 to 100. Scores > 31 indicate tinnitus is a moderate to significant problem. A reduction of 13 points in TFI is considered the Minimal Clinically Important Difference (MCID).
4 secondary outcomes
Patient Health Questionnaire (PHQ)
Time frame: Baseline and 8 weeks
Perceived Stress Scale (PSS)
Time frame: Baseline and 8 weeks
Pittsburgh Sleep Quality Index (SQI)
Time frame: Baseline and 8 weeks
Generalized Anxiety Disorder (GAD-7)
Time frame: Baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19472451Evans RW, Ishiyama G. Migraine with transient unilateral hearing loss and tinnitus. Headache. 2009 May;49(5):756-8. doi: 10.1111/j.1526-4610.2008.01075.x. No abstract available.
- Background: PubMed 14663349Sindhusake D, Golding M, Newall P, Rubin G, Jakobsen K, Mitchell P. Risk factors for tinnitus in a population of older adults: the blue mountains hearing study. Ear Hear. 2003 Dec;24(6):501-7. doi: 10.1097/01.AUD.0000100204.08771.3D.
- Background: PubMed 10443820Dobie RA. A review of randomized clinical trials in tinnitus. Laryngoscope. 1999 Aug;109(8):1202-11. doi: 10.1097/00005537-199908000-00004.
- Background: PubMed 26583133Langguth B, Hund V, Busch V, Jurgens TP, Lainez JM, Landgrebe M, Schecklmann M. Tinnitus and Headache. Biomed Res Int. 2015;2015:797416. doi: 10.1155/2015/797416. Epub 2015 Oct 25.
- Background: PubMed 28894434Langguth B, Hund V, Landgrebe M, Schecklmann M. Tinnitus Patients with Comorbid Headaches: The Influence of Headache Type and Laterality on Tinnitus Characteristics. Front Neurol. 2017 Aug 28;8:440. doi: 10.3389/fneur.2017.00440. eCollection 2017.
- Background: PubMed 27197786Guichard E, Montagni I, Tzourio C, Kurth T. Association Between Headaches and Tinnitus in Young Adults: Cross-Sectional Study. Headache. 2016 Jun;56(6):987-94. doi: 10.1111/head.12845. Epub 2016 May 20.
- Background: PubMed 6417606Duckert LG, Rees TS. Treatment of tinnitus with intravenous lidocaine: a double-blind randomized trial. Otolaryngol Head Neck Surg. 1983 Oct;91(5):550-5. doi: 10.1177/019459988309100514.
- Background: PubMed 15250126Hallam RS, McKenna L, Shurlock L. Tinnitus impairs cognitive efficiency. Int J Audiol. 2004 Apr;43(4):218-26. doi: 10.1080/14992020400050030.
- Background: PubMed 16280464Muhlau M, Rauschecker JP, Oestreicher E, Gaser C, Rottinger M, Wohlschlager AM, Simon F, Etgen T, Conrad B, Sander D. Structural brain changes in tinnitus. Cereb Cortex. 2006 Sep;16(9):1283-8. doi: 10.1093/cercor/bhj070. Epub 2005 Nov 9.
- Background: PubMed 19413945Landgrebe M, Langguth B, Rosengarth K, Braun S, Koch A, Kleinjung T, May A, de Ridder D, Hajak G. Structural brain changes in tinnitus: grey matter decrease in auditory and non-auditory brain areas. Neuroimage. 2009 May 15;46(1):213-8. doi: 10.1016/j.neuroimage.2009.01.069. Epub 2009 Feb 12.
- Background: PubMed 19693001Price JL, Drevets WC. Neurocircuitry of mood disorders. Neuropsychopharmacology. 2010 Jan;35(1):192-216. doi: 10.1038/npp.2009.104.
- Background: PubMed 10373114Ploghaus A, Tracey I, Gati JS, Clare S, Menon RS, Matthews PM, Rawlins JN. Dissociating pain from its anticipation in the human brain. Science. 1999 Jun 18;284(5422):1979-81. doi: 10.1126/science.284.5422.1979.
- Individual participant dataSharing planned: Undecided
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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.
Hamid R Djalilian, MD principal investigator
Univeristy 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 Verapamil + Paroxetine in people with Tinnitus, Subjective and 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: finished, as of the sponsor's last update on 16 Apr 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 16 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (TFI) (time frame: Baseline and 8 weeks (end of trial)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04404439, which also lists 17 linked publications.
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 16 Apr 2026.