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Can a numbing nose treatment stop migraine pain in its tracks?

NCT ID NCT07764783

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This trial tests whether applying a numbing medicine (lidocaine) to a nerve cluster inside the nose can quickly relieve migraine headaches, facial pain, and neck pain. Adults who have frequent headaches and facial pressure will receive either lidocaine or a saltwater placebo during a short scope-guided procedure. Researchers will track pain levels for 24 hours and monitor headache days over two months to see if the treatment helps.

What this could mean

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

Active substance
A numbing medicine (lidocaine) applied directly to a nerve cluster inside the nose using a scope
What this could lead to
If it works, this could offer a quick, drug-free way to stop migraine pain and related facial or neck pain without needing daily pills.
What could go wrong
This is a small, early-stage trial, so results may not apply to everyone. The procedure involves placing medicine in the nose, which could cause discomfort or side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 74 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

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: * Aged 18 years or older * Any race * Any gender * At least 2 of 3 positives (a, b, c) below on the ID Migraine Screener from the American Headache Society: 1. Photophobia 2. Inability to function 3. Nausea * At least 3 months of patient-reported episodic or persistent discomfort, pain, or pressure in the anatomic distribution of the paranasal sinuses, orbits, or nasal cavities. * The patient experiences at least 10 days of headaches and/or FPP within a 30-day period, during the run-in phase. * No evidence of abnormal sinus findings on imaging \[paranasal sinus CT, including cone beam imaging, or MRI (MRI images must include all paranasal sinuses) obtained when symptomatic in the last 12 months prior to presentation. Normal imaging findings included isolated mucus retention cysts 2 cm or less in size and minimal non-circumferential (isolated areas) mucosal thickening (3mm or less). * Normal endoscopy if performed prior to enrollment, defined as the absence of purulent (opaque - white or other discolored - secretions) at the middle meatus or sphenoethmoid recess or nasal polyp disease. * Daily access to a cell phone that can function with the study mobile application * For women of child bearing potential: not pregnant and using a method of contraception during the duration of the study. * The patient can be taking interventional and preventive medications and other treatments before and during the study period, including new medications which will be tracked. The clinical coordinator will ask the patient to refrain from taking any abortive medication, cannabis, and psilocybin 24 hours prior to the procedure visit. Exclusion criteria: * Prior endoscopic sinus surgery within the 3 months prior to enrollment. * Nasal endoscopy if performed prior to enrollment shows severe signs of mucosal infection, (mucopurulent drainage) or nasal polyposis. * A history of anterior skull base neoplasia. * Nasal endoscopy if performed prior to enrollment does not allow visualization of the middle turbinate on endoscopy bilaterally after application of a topical decongestant. * Signs of active or chronic sinusitis on CT (\>3mm mucosal thickening or air fluid level in any paranasal sinus.) * The patient cannot tolerate the use of topical anesthetics or intranasal endoscopy without sedation or general anesthesia * Unable to see the middle meatus with either a nasal speculum or an endoscope * Allergy to lidocaine or other local anesthetics (tertiary amine class 1b). * Is currently using a schedule II narcotic for migraine pain. * Current cocaine use or cocaine use within the last 30 days. * Currently immunocompromised * History or evidence of any other unstable or clinically significant medical condition that in the opinion of the sponsor-investigator/ Principal Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. * Has received any investigational agent within 30 days of enrollment. * Plans to participate in a concurrent clinical trial.

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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

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ear, Nose, & Throat Surgeons of Western New England

    Springfield, Massachusetts, 01107, United States

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