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Ringing relief? migraine drugs tested for tinnitus in new study

NCT ID NCT07655440

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

Many people with migraine also suffer from tinnitus, a persistent ringing in the ears. This trial will compare two types of migraine preventives—newer anti-CGRP drugs and older medications like antidepressants and blood pressure drugs—to see which better reduces tinnitus symptoms. 120 adults with both conditions will be randomly assigned to one of the two groups and followed for 24 weeks. The study is run by Stanford University and is not yet recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
migraine preventive medications (anti-CGRP drugs like galcanezumab, erenumab, eptinezumab, atogepant; and conventional drugs like amitriptyline, nortriptyline, propranolol, verapamil)
What this could lead to
If it works, this could point toward a new treatment option for tinnitus in people with migraine, potentially reducing the ringing in their ears.
What could go wrong
This is a Phase 4 trial with only 120 participants, so results may not apply to everyone. It is also possible that neither drug class helps tinnitus more than the other.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 years or older * Non-pulsatile, subjective tinnitus present for at least 6 months * Tinnitus Functional Index (TFI) score greater than 25 at screening, indicating at least mild-to-moderate tinnitus burden * Current or past history of migraine, vestibular migraine, or episodic headache disorder, diagnosed by a physician or meeting ICHD-3 criteria * Clinically appropriate candidate for migraine preventive therapy as determined by the treating clinician * Stable medication regimen for at least 3 months prior to enrollment (no new medications started or stopped within 3 months of screening) * Ability to provide written informed consent * Ability to complete self-report questionnaires in English or with certified interpreter assistance * Willingness to attend three in-person study visits over 24 weeks and complete daily symptom diaries Exclusion Criteria: * Pulsatile tinnitus or objective tinnitus (tinnitus audible to examiner) * Pregnancy, planned pregnancy during the study period, or breastfeeding * Participation in any other interventional tinnitus treatment research protocol during the study period * Currently receiving a CGRP-targeting medication (for participants being considered for the conventional arm) or a conventional migraine preventive medication listed in this protocol (for participants being considered for the CGRP arm) - to avoid within-arm ineligibility at randomization * Known contraindication to all medications within the assigned study arm * History of serious cardiovascular event (myocardial infarction, stroke, or unstable angina) within 6 months of enrollment * Severe hepatic or renal impairment that would contraindicate study medications * Active psychiatric disorder requiring medication adjustment within 3 months of enrollment * Known hypersensitivity or prior serious adverse reaction to a medication within the assigned study arm * Active malignancy or life expectancy less than 12 months * Inability to complete study procedures or follow-up visits in the judgment of the investigator

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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