Trial Outcomes & Findings for Treatment of Tinnitus With Migraine Medications (NCT NCT04404439)

The study was conducted at the neurotology clinic of the UC Irvine Medical Center, was approved by the Institutional Review Board, and registered on ClinicalTrials.gov (NCT04404439). After consenting, participants were randomized among 3 parallel arms. participants were contacted by a blinded physician via telephone once per week during the trial and in-person visits were

Participants had to be compliant with the medication regimen and attend study visits. They underwent comprehensive otolaryngologic assessments, including an audiogram, and provided informed consent. In addition, patients underwent a magnetic Exclusion criteria included pregnancy, psychosis, neurological neoplasm, active ear disease affecting hearing, allergies or adverse reactions to study medications, concerning medical conditions like arrhythmia, and any contraindications to the study drugs.

Race and Ethnicity were not collected from any participant.

The TFI is a 25 item questionnaire rated on a 0 to 10 scale evaluating the negative impact of tinnitus across 8 domains: Intrusive, Sense of control, Cognitive, Sleep, Auditory, Relaxation, Quality of life, and Emotional. A 0 score indicates low to no impact where a 10 would indicate distress or great impact. The overall TFI score is calculated by dividing the sum of the responses (max possible 250) by the number of responses to get the mean, then multiplying the mean by 10 to obtain the overall TFI score. Overall TFI score can range from 0 to 100. Scores \> 31 indicate tinnitus is a moderate to significant problem. A reduction of 13 points in TFI is considered the Minimal Clinically Important Difference (MCID).

Change in depression symptoms based on the Patient Health Questionnaire-9 (PHQ-9), scored from 0 to 27. Higher scores indicate greater symptom severity. A negative change reflects improvement. Mean changes from baseline to Week 8 were analyzed using paired t-tests (per-protocol). A ≥5-point improvement was considered the minimal clinically important difference (MCID).

Change in perceived stress symptoms based on the Perceived Stress Scale (PSS), scored from 0 to 40. The PSS is a 10 question Likert-type scale with answers ranging from (0) "Never" to (4) "Very often". Four questions with positive statements are scored in reverse (0 = 4, 1 = 3, 2 = 2, 3 = 1, 4 = 0). Higher scores indicate greater stress. A negative change reflects improvement. Mean changes from baseline to Week 8 were analyzed using paired t-tests (per-protocol). A ≥11-point improvement was considered the minimal clinically important difference (MCID).

Change in sleep quality based on the Pittsburgh Sleep Quality Index (PSQI), scored from 0 to 21. Higher scores indicate poorer sleep quality. A negative change reflects improvement. Mean changes from baseline to Week 8 were analyzed using paired 2-tailed t-tests (per-protocol). Standard error was calculated using end-of-trial SD and sample size. A ≥3-point improvement was considered the minimal clinically important difference (MCID).

Change in anxiety symptoms based on the Generalized Anxiety Disorder-7 (GAD-7) scale, scored from 0 to 21. Higher scores indicate greater anxiety. A negative change reflects improvement. Mean changes from baseline to Week 8 were analyzed using paired 2-tailed t-tests (per-protocol). Standard error was calculated using end-of-trial SD and sample size. A ≥4-point improvement was considered the minimal clinically important difference (MCID).