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NCT06799169 · ClinicalTrials.gov registry record · Phase 4

Management of Acute Tinnitus With Migraine Medications

A Phase 4 study of Tinnitus, sponsored by University of California, Irvine.

Active
Registry status
Phase 4
Development phase
100
Enrollment target
1
Study location

NCT06799169: Active Phase 4 study of Tinnitus, sponsored by University of California, Irvine.

NCT06799169 is a Phase 4 study of Tinnitus that is active but no longer recruiting, run by University of California, Irvine. The registered enrollment target is 100 participants, below the 12,616-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.

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The verdict

NCT06799169, a Phase 4 study of Tinnitus, is active but no longer recruiting, sponsored by University of California, Irvine.

ACTIVE NOT RECRUITING
Registry status
Phase 4
Development phase
100 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. 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.

Primary Outcome

The primary outcome endpoint is a Tinnitus Functional Index (TFI) score which comprehensively evaluates the negative impact of tinnitus across 8 domains each focusing on specific dimensions: Intrusive, Sense of control, Cognitive, Sleep, Auditory, Relaxation, Quality of life, and Emotional. The overall score ranges from 0 to 100. Changes 13 points in TFI are the Minimal Clinically Important Difference (MCID). Subjective improvement from baseline in tinnitus symptoms as measured by Tinnitus Funct

Conditions Studied

Tinnitus

Interventions

  • DRUG Paroxetine
  • DRUG Topiramate
  • DRUG Nortriptyline
  • DRUG Verapamil

Study Locations (1)

California

  • University of California, Irvine Medical Center ENT Clinic (Pavilion 2) - Orange

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2025-06-01
Est. Completion 2026-12
Phase Phase 4
University of California, Irvine

368 total trials

What the registry record for NCT06799169 still lists

NCT06799169 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 12,616-participant average among 24 other Tinnitus trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Tinnitus appearing as the primary indexed condition, and to 4 interventions - of which Paroxetine is the first listed.

NCT06799169 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT06799169 about?

NCT06799169 is a clinical study titled "Management of Acute 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. Despite too many research projects on finding the mechanism of tinnitus, its pathophysiology remains poorly understood. It ...

What is the current status of trial NCT06799169?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2025-06-01. Estimated completion is 2026-12.

What conditions does trial NCT06799169 study?

This clinical trial studies the following conditions: Tinnitus.

What interventions are being tested in trial NCT06799169?

The interventions under investigation include: Paroxetine (DRUG), Topiramate (DRUG), Nortriptyline (DRUG), Verapamil (DRUG).

Who is sponsoring clinical trial NCT06799169?

This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06799169 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 NCT06799169's enrollment target sits among peer trials

100 11th of 24 higher than 13 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

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Related registry views

Source: ClinicalTrials.gov NCT06799169, the US trial registry maintained by the National Library of Medicine. NCT06799169 (mid enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.