Treatment of Tinnitus With Migraine Medications
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04404439|
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : May 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus, Subjective Tinnitus||Drug: Nortriptyline + topiramate Drug: Verapamil + paroxetine Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|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)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Hamid R Djalilian, MDfirstname.lastname@example.org|
|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 email@example.com|
|Contact: Mehdi Abouzari, MD, PhD 714-509-6096 firstname.lastname@example.org|
|Principal Investigator: Hamid R Djalilian, MD|
|Sub-Investigator: Mehdi Abouzari, MD, PhD|
|Principal Investigator:||Hamid R Djalilian, MD||Univeristy of California, Irvine|