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Treatment of Tinnitus With Migraine Medications

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ClinicalTrials.gov Identifier: NCT04404439
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : June 2, 2021
Information provided by (Responsible Party):
Hamid Djalilian, University of California, Irvine

Brief 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.

Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Tinnitus Drug: Nortriptyline + topiramate Drug: Verapamil + paroxetine Other: Placebo Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to a study group by chance (like a coin flip) rather than by a medical decision made by the researchers. There are three arms in the study (treatment group 1 which consists of nortriptyline + topiramate, treatment group 2 which consist of verapamil + paroxetine, and a placebo group), and participants enrolling in the trial will be randomly assigned in a 1:1:1 fashion to one of the arms. The participant will remain in the same arm for the duration of the study (8 weeks). There may be multiple participants in each arm who are undergoing the study at the same time (parallel model).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Tinnitus With Migraine Medications: A Randomized Clinical Trial
Actual Study Start Date : September 26, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine Tinnitus

Arm Intervention/treatment
Experimental: 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.
Drug: Nortriptyline + topiramate
Treatment group 1

Experimental: 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.
Drug: Verapamil + paroxetine
Treatment group 2

Placebo Comparator: Placebo
Placebo pill.
Other: Placebo
Placebo comparator

Primary Outcome Measures :
  1. Tinnitus Functional Index (TFI) [ Time Frame: 8 weeks ]
    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.

Secondary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: 8 weeks ]
    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.

  2. Patient Health Questionnaire (PHQ) [ Time Frame: 8 weeks ]
    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.

  3. Perceived Stress Scale (PSS) [ Time Frame: 8 weeks ]
    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.

  4. Sleep Quality Index (SQI) [ Time Frame: 8 weeks ]
    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.

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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404439

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Contact: Hamid R Djalilian, MD 800-263-9547 hdjalili@hs.uci.edu

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United States, California
University of California, Irvine Medical Center ENT Clinic (Pavilion 2) Recruiting
Orange, California, United States, 92868
Contact: Hamid R Djalilian, MD    800-263-9547    hdjalili@hs.uci.edu   
Contact: Mehdi Abouzari, MD, PhD    714-509-6096    mabouzar@hs.uci.edu   
Principal Investigator: Hamid R Djalilian, MD         
Sub-Investigator: Mehdi Abouzari, MD, PhD         
Sponsors and Collaborators
University of California, Irvine
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Principal Investigator: Hamid R Djalilian, MD Univeristy of California, Irvine

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Responsible Party: Hamid Djalilian, Professor, Neurotology and Skull Base Surgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT04404439    
Other Study ID Numbers: HS# 2018-4458
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hamid Djalilian, University of California, Irvine:
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Hypoglycemic Agents
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors