Clinical trial NCT06799169: Management of Acute Tinnitus With Migraine Medications
Official title: Management of Acute Tinnitus With Migraine Medications: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Tinnitus
Keywords: Tinnitus
Acute tinnitus
Atypical migraine
ringing in ears
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an 8-week, randomized, double-blind, single-center clinical trial, consisting of two arms: Group N-T, a nortriptyline (7.5mg) plus topiramate (10mg) group and group V-P, a verapamil (30mg) plus paroxetine (4mg) group. Both groups may involve dose escalation from the initial dosage during the study.
Primary purpose: TREATMENT

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. Despite too many research projects on finding the mechanism of tinnitus, its pathophysiology remains poorly understood. It is well understood that many factors, such as poor education, lower income, or occupational, and recreational activity associated with high noise exposure, influence 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, the investigators intend to use medications for patients with acute tinnitus to decrease the impact of tinnitus in their daily lives and activities. There are some studies on medications treating tinnitus; however, there are few randomized clinical trials to prove the efficacy of the treatment. The frequency and loudness of tinnitus will be measured before and after the course. Functional MRI of the brain will be obtained to view any changes that may occur before and after the treatment.

Detailed description: This study is 8-weeks in duration. There are two arms in the experiment: the first is nortriptyline (7.5 mg) plus topiramate (10 mg), the second is verapamil (240 mg) plus paroxetine (32 mg). 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 groups may receive dosage increases weekly if symptoms do not improve. Symptomatic survey scores from each arm will be obtained before and after treatment and weekly. An unblinded clinical researcher will also become involved with patients\&#39; 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.

Eligibility criteria: Inclusion Criteria:

* Patients with mild to moderate tinnitus.
* Male or female between the ages of 25 to 85 years.
* Subjects must be compliant with the medication and attend study visits.
* Must be able to read and write in the English language to provide consent.

Exclusion Criteria:

* Pregnancy will result in automatic exclusion from the study. Rule out of pregnancy will be done by urine pregnancy test to confirm the situation for all women who are of childbearing potential.
* Subjects with a history of an adverse reaction to medication being prescribed.
* Subjects suffering from a medical condition or have a history that may be concerning to the investigator's clinical opinion.
* All contraindications for the medications that prevent subjects from randomization will be considered as exclusion criteria.

Primary outcomes:
measure: Tinnitus Functional Index
timeFrame: 8 weeks
Secondary outcomes:
measure: Tinnitus Functional Index (TFI)
timeFrame: 8 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: 8 weeks
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 8 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 8 weeks
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: 8 weeks
measure: Visual Analog Scale (VAS)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center ENT Clinic (Pavilion 2)
state: California
Study officials:
affiliation: University of California, Irvine
name: Mehdi Abouzari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: