Nortriptyline + topiramate for Tinnitus
Phase-Based Progress Estimates
Effectiveness
Safety
Tinnitus+2 More
Nortriptyline + topiramate - DrugEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
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
- Tinnitus, Subjective
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 8 weeks
8 weeks
Patient Health Questionnaire (PHQ)
Perceived Stress Scale (PSS)
Sleep Quality Index (SQI)
Tinnitus Functional Index (TFI)
Visual Analog Scale (VAS)
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
3 Treatment Groups
Verapamil + paroxetine
1 of 3
Nortriptyline + topiramate
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group
150 Total Participants · 3 Treatment Groups
Primary Treatment: Nortriptyline + topiramate · Has Placebo Group · Phase 4
Verapamil + paroxetine
Drug
Experimental Group · 1 Intervention: Verapamil + paroxetine · Intervention Types: DrugNortriptyline + topiramate
Drug
Experimental Group · 1 Intervention: Nortriptyline + topiramate · Intervention Types: DrugPlacebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks
Who is running the clinical trial?
University of California, IrvineLead Sponsor
496 Previous Clinical Trials
1,878,163 Total Patients Enrolled
3 Trials studying Tinnitus
223 Patients Enrolled for Tinnitus
Hamid R Djalilian, MDPrincipal InvestigatorUniveristy of California, Irvine
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:The subject must take the medication as prescribed and attend all study visits.
You must be able to read and write in English in order to provide consent.
Patients who have tinnitus that is moderate to severe.
You must be at least 25 years old and no older than 85 to be a part of this study.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| Texas | 22.2% |
| California | 22.2% |
| Missouri | 11.1% |
| Other | 44.4% |
How old are they?
| 18 - 65 | 75.0% |
| 65+ | 25.0% |
What site did they apply to?
| University of California, Irvine Medical Center ENT Clinic (Pavilion 2) | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 25.0% |
| Met criteria | 75.0% |
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- University of California, Irvine Medical Center ENT Clinic (Pavilion 2): < 48 hours
Typically responds via
| 100.0% | |
References
- Sindhusake, Doungkamol, Maryanne Golding, Philip Newall, George Rubin, Kirsten Jakobsen, and Paul Mitchell. 2003. “Risk Factors for Tinnitus in a Population of Older Adults: The Blue Mountains Hearing Study”. Ear & Hearing. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.aud.0000100204.08771.3d.
- Dobie, Robert A.. 1999. “A Review of Randomized Clinical Trials in Tinnitus”. The Laryngoscope. Wiley. doi:10.1097/00005537-199908000-00004.
- Duckert, Larry G., and Thomas S. Rees. 1983. “Treatment of Tinnitus with Intravenous Lidocaine: A Double-blind Randomized Trial”. Otolaryngology–head and Neck Surgery. SAGE Publications. doi:10.1177/019459988309100514.
- Price, Joseph L, and Wayne C Drevets. 2009. “Neurocircuitry of Mood Disorders”. Neuropsychopharmacology. Springer Science and Business Media LLC. doi:10.1038/npp.2009.104.
- Ploghaus, Alexander, Irene Tracey, Joseph S. Gati, Stuart Clare, Ravi S. Menon, Paul M. Matthews, and J. Nicholas P. Rawlins. 1999. “Dissociating Pain from Its Anticipation in the Human Brain”. Science. American Association for the Advancement of Science (AAAS). doi:10.1126/science.284.5422.1979.
- Roberts, L. E., J. J. Eggermont, D. M. Caspary, S. E. Shore, J. R. Melcher, and J. A. Kaltenbach. 2010. “Ringing Ears: The Neuroscience of Tinnitus”. Journal of Neuroscience. Society for Neuroscience. doi:10.1523/jneurosci.4028-10.2010.
- Minen, Mia T, Joan Camprodon, Romy Nehme, and Zeina Chemali. 2014. “The Neuropsychiatry of Tinnitus: A Circuit-based Approach to the Causes and Treatments Available”. Journal of Neurology, Neurosurgery & Psychiatry. BMJ. doi:10.1136/jnnp-2013-307339.
- Mühlnickel, Werner, Thomas Elbert, Edward Taub, and Herta Flor. 1998. “Reorganization of Auditory Cortex in Tinnitus”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.95.17.10340.
- Guichard, Elie, Ilaria Montagni, Christophe Tzourio, and Tobias Kurth. 2016. “Association Between Headaches and Tinnitus in Young Adults: Cross-sectional Study”. Headache: The Journal of Head and Face Pain. Wiley. doi:10.1111/head.12845.
- Hallam, R. S., L. Mckenna, and L. Shurlock. 2004. “Tinnitus Impairs Cognitive Efficiency”. International Journal of Audiology. Informa UK Limited. doi:10.1080/14992020400050030.
- Mühlau, M., J. P. Rauschecker, E. Oestreicher, C. Gaser, M. Röttinger, A. M. Wohlschläger, F. Simon, T. Etgen, B. Conrad, and D. Sander. 2005. “Structural Brain Changes in Tinnitus”. Cerebral Cortex. Oxford University Press (OUP). doi:10.1093/cercor/bhj070.
- Landgrebe, Michael, Berthold Langguth, Katharina Rosengarth, Susanne Braun, Amelie Koch, Tobias Kleinjung, Arne May, Dirk de Ridder, and Goeran Hajak. 2009. “Structural Brain Changes in Tinnitus: Grey Matter Decrease in Auditory and Non-auditory Brain Areas”. Neuroimage. Elsevier BV. doi:10.1016/j.neuroimage.2009.01.069.
- Wager, Tor D., James K. Rilling, Edward E. Smith, Alex Sokolik, Kenneth L. Casey, Richard J. Davidson, Stephen M. Kosslyn, Robert M. Rose, and Jonathan D. Cohen. 2004. “Placebo-induced Changes in Fmri in the Anticipation and Experience of Pain”. Science. American Association for the Advancement of Science (AAAS). doi:10.1126/science.1093065.
- Evans, Randolph W., and Gail Ishiyama. 2009. “Migraine with Transient Unilateral Hearing Loss and Tinnitus”. Headache: The Journal of Head and Face Pain. Wiley. doi:10.1111/j.1526-4610.2008.01075.x.
- Langguth, Berthold, Verena Hund, Volker Busch, Tim P. Jürgens, Jose-Miguel Lainez, Michael Landgrebe, and Martin Schecklmann. 2015. “Tinnitus and Headache”. Biomed Research International. Hindawi Limited. doi:10.1155/2015/797416.
- Langguth, Berthold, Verena Hund, Michael Landgrebe, and Martin Schecklmann. 2017. “Tinnitus Patients with Comorbid Headaches: The Influence of Headache Type and Laterality on Tinnitus Characteristics”. Frontiers in Neurology. Frontiers Media SA. doi:10.3389/fneur.2017.00440.
- Llinás, Rodolfo R., Urs Ribary, Daniel Jeanmonod, Eugene Kronberg, and Partha P. Mitra. 1999. “Thalamocortical Dysrhythmia: A Neurological and Neuropsychiatric Syndrome Characterized by Magnetoencephalography”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.96.26.15222.
- Hamid Djalilian 2019. "Treatment of Tinnitus With Migraine Medications". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04404439.
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