Treatment of Tinnitus With Migraine Medications

Tinnitus Clinical Trial

Official title:

Treatment of Tinnitus With Migraine Medications: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04404439
• Other study ID #: HS# 2018-4458
• Status: Recruiting
• Phase: Phase 4
• Start date: September 26, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2023
• Source: University of California, Irvine
• Contact: Hamid R Djalilian, MD
• Phone: 800-263-9547
• Email: hdjalili[@]hs.uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. It is well-understood that many factors, such as poor education, lower income, or occupational, and recreational activity associated with high noise exposure, influences 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, we intend to use medications for patients with tinnitus in order to decrease the impact of tinnitus on their daily life and activities.

Description:

This study is 8 weeks in duration. There are three arms in the experiment: 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. 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. Both medication combinations and placebo may include dosage increases weekly if symptoms do not improve. 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). Symptomatic survey scores from each arm will be obtained before and after treatment and weekly. An unblinded neurotologist attending (Dr. Harrison Lin) will also become involved with patients' treatments as they start to report changes in symptoms in order to monitor their safety and provide advice on change in dosage if patients have questions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Migraine Disorders
• Tinnitus
• Tinnitus, Subjective

Intervention

Drug:
• Nortriptyline + topiramate
Treatment group 1
• Verapamil + paroxetine
Treatment group 2

Other:
• Placebo
Placebo comparator

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center ENT Clinic (Pavilion 2)	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (17)

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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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Secondary	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 an increased severity of tinnitus.	8 weeks
Secondary	Patient Health Questionnaire (PHQ)	Subjective improvement in depression symptoms based on patient health questionnaire (PHQ). The PHQ is scored from 0 to 27, with a higher score indicating increased depression severity.	8 weeks
Secondary	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.	8 weeks
Secondary	Sleep Quality Index (SQI)	Subjective improvement in sleep quality based on sleep quality index (SQI). The SQI is scored from 0 to 21, with higher scores indicating worse quality of sleep.	8 weeks