Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04404439 · ClinicalTrials.gov registry record · Phase 4
Treatment of Tinnitus With Migraine Medications
A Phase 4 study of Tinnitus and Tinnitus, Subjective, sponsored by University of California, Irvine.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT04404439: Recruiting Phase 4 study of Tinnitus and Tinnitus, Subjective, sponsored by University of California, Irvine.
NCT04404439 is a Phase 4 study of Tinnitus and Tinnitus, Subjective that is actively recruiting participants, run by University of California, Irvine. The registered enrollment target is 150 participants, below the 12,613-participant average among 24 other Tinnitus trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04404439, a Phase 4 study of Tinnitus and Tinnitus, Subjective, is actively recruiting participants, sponsored by University of California, Irvine.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Nortriptyline + topiramate
- DRUG Verapamil + paroxetine
Study Locations (1)
California
- University of California, Irvine Medical Center ENT Clinic (Pavilion 2) - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2019-09-26 |
| Est. Completion | 2023-12-30 |
| Phase | Phase 4 |
What NCT04404439 shows while recruiting
NCT04404439 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 12,613-participant average among 24 other Tinnitus trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Tinnitus appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04404439 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04404439 about?
NCT04404439 is a clinical study titled "Treatment of Tinnitus With Migraine Medications". 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 a...
What is the current status of trial NCT04404439?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2019-09-26. Estimated completion is 2023-12-30.
What conditions does trial NCT04404439 study?
This clinical trial studies the following conditions: Tinnitus, Tinnitus, Subjective.
What interventions are being tested in trial NCT04404439?
The interventions under investigation include: Placebo (OTHER), Nortriptyline + topiramate (DRUG), Verapamil + paroxetine (DRUG).
Who is sponsoring clinical trial NCT04404439?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04404439 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tinnitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04404439's enrollment target sits among peer trials
150 8th of 24 higher than 17 of 24 other Tinnitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tinnitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Management of Acute Tinnitus With Migraine Medications
ACTIVE NOT RECRUITING · Phase 4
-
Treatment for PTSD and Tinnitus
RECRUITING · NA
-
Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation
RECRUITING · NA
-
Somatosensory Tinnitus RCT
RECRUITING · NA
-
An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus
RECRUITING · Early Phase 1
-
Noninvasive Therapy for Tinnitus
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00412594 · 150 participants · Phase 2
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
- NCT01484730 · 150 participants
A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion
- NCT01985919 · 150 participants
Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples
- NCT02016248 · 150 participants · NA
SBRT Boost for Unfavorable Prostate Cancer'
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI