Treatment of Tinnitus With Migraine Medications
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Tinnitus
- Tinnitus, Subjective
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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
Participation Requirements
- Age
- Between 25 years and 85 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04404439
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Hamid R Djalilian, MD Univeristy of California, Irvine
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