Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
150 participants
INTERVENTIONAL
2019-09-26
2023-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Nortriptyline + topiramate
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.
Nortriptyline + topiramate
Treatment group 1
Verapamil + paroxetine
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.
Verapamil + paroxetine
Treatment group 2
Placebo
Placebo pill.
Placebo
Placebo comparator
Interventions
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Nortriptyline + topiramate
Treatment group 1
Verapamil + paroxetine
Treatment group 2
Placebo
Placebo comparator
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
25 Years
85 Years
ALL
No
Sponsors
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University of California, Irvine
OTHER
Responsible Party
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Hamid Djalilian
Professor, Neurotology and Skull Base Surgery
Principal Investigators
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Hamid R Djalilian, MD
Role: PRINCIPAL_INVESTIGATOR
Univeristy of California, Irvine
Locations
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University of California, Irvine Medical Center ENT Clinic (Pavilion 2)
Orange, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Landgrebe 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.
Price JL, Drevets WC. Neurocircuitry of mood disorders. Neuropsychopharmacology. 2010 Jan;35(1):192-216. doi: 10.1038/npp.2009.104.
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.
Sindhusake 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.
Dobie RA. A review of randomized clinical trials in tinnitus. Laryngoscope. 1999 Aug;109(8):1202-11. doi: 10.1097/00005537-199908000-00004.
Langguth 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.
Langguth 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.
Guichard 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.
Duckert 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.
Hallam RS, McKenna L, Shurlock L. Tinnitus impairs cognitive efficiency. Int J Audiol. 2004 Apr;43(4):218-26. doi: 10.1080/14992020400050030.
Muhlau 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.
Ploghaus 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.
Wager 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.
Roberts 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.
Minen 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.
Llinas RR, Ribary U, Jeanmonod D, Kronberg E, Mitra PP. Thalamocortical dysrhythmia: A neurological and neuropsychiatric syndrome characterized by magnetoencephalography. Proc Natl Acad Sci U S A. 1999 Dec 21;96(26):15222-7. doi: 10.1073/pnas.96.26.15222.
Muhlnickel W, Elbert T, Taub E, Flor H. Reorganization of auditory cortex in tinnitus. Proc Natl Acad Sci U S A. 1998 Aug 18;95(17):10340-3. doi: 10.1073/pnas.95.17.10340.
Other Identifiers
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HS# 2018-4458
Identifier Type: -
Identifier Source: org_study_id
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