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Not yet taking people in United StatesPhase 2

Numbing Medicine Tested Inside the Nose for Migraine Headaches

Tests numbing lidocaine inside the nose in adults with migraine headaches.

Key facts

Who runs it
Association of Migraine Disorders
Where
Springfield, United StatesSee the site
Trial code
Registry title
Visual Instillation of Sphenopalatine-block Intervention for ONgoing Migraine
Status
Not yet recruiting
Phase
Phase 2
People taking part
74 people, planned
Starts
Jan 2027
Expected to end
Jan 2029
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Topical solution of 4% lidocaine
  • Saline 0.9%
Record updated
9 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with migraine and headache or facial pain or pressure, with normal sinus findings, to test lidocaine numbing medicine applied inside the nose.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
At least 2 of 3 on the migraine screener (light sensitivity, inability to function, nausea). Pain or pressure around the sinuses, eyes or nose for at least 3 months. At least 10 days of headache or facial pain or pressure in a 30-day period. No abnormal sinus findings on imaging in the last 12 months.
Earlier treatment
Other preventive and interventional treatments can continue. No endoscopic sinus surgery in the 3 months before joining. No abortive medication, cannabis or psilocybin for 24 hours before the procedure visit.

Main reasons for not taking part

  • Allergy to lidocaine or other local anesthetics
  • Signs of active or chronic sinusitis, or nasal polyps, on imaging or endoscopy
  • Currently immunocompromised
  • Cocaine use in the last 30 days, or current use of a schedule II narcotic for migraine pain
  • Any investigational agent in the last 30 days, or plans to join another trial

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • 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:; Photophobia; Inability to function; 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

Who cannot take part

  • 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
  • Nasal endoscopy if performed prior to enrollment does not allow visualization of the middle turbinate on endoscopy bilaterally after application of a topical decongestant
  • Is currently using a schedule II narcotic for migraine pain
  • Has received any investigational agent within 30 days of enrollment
  • Plans to participate in a concurrent clinical trial
  • A history of anterior skull base neoplasia
  • Allergy to lidocaine or other local anesthetics (tertiary amine class 1b)
  • 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
  • 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
  • Current cocaine use or cocaine use within the last 30 days
  • Currently immunocompromised

Where in United States

  • Ear, Nose, & Throat Surgeons of Western New EnglandSpringfield, United StatesContact: Study CoordinatorNot yet recruiting

About the trial

What the trial wants to find out

The goal of this double-blinded, randomized placebo controlled clinical trial is to to see if using a numbing medicine (lidocaine) on certain areas inside the nose can help with headaches, neck pain, facial pain and pressure, and other symptoms. It also aims to understand the pathophysiology that causes these symptoms.

Read full original descriptionShow less

The main questions it aims to answer are:

1. Is applying numbing medication directly to the sphenopalatine ganglion (SPG) area, while watching through the scope to make sure it's in the right place, a workable and effective way to treat migraine headaches immediately and 24 hours? 2. Is applying numbing medication directly to the sphenopalatine ganglion (SPG) area, while watching through the scope to make sure it's in the right place, a workable and effective way to improve patient-reported outcomes? 3. Does daily lidocaine nasal spray improve patient-reported outcomes?

The 3-month study requires:

* One virtual visit (on the computer) * One visit to the office for placement of the numbing medicine under direct vision * One week of daily nasal spray treatment * Daily headache diary entries that take less than two minutes to complete

The 4 groups in the trial

  • Topical lidocaine endoscopically-guided intranasal nerve blockTreatment being tested

    Topical solution of 4% lidocaine on small cotton pledgets with be placed endoscopically at the posterior root of the middle turbinate and in the anterior ethmoid nerve region bilaterally for Sphenopalatine Ganglion Block (SPG) block with anterior ethmoid (AE) block.

    Treatment: Topical solution of 4% lidocaine

  • Placebo (saline) endoscopically-guided intranasal nerve blockPlacebo, for comparison

    Topical solution of saline on small cotton pledgets with be placed endoscopically at the posterior root of the middle turbinate and in the anterior ethmoid nerve region bilaterally for Sphenopalatine Ganglion Block (SPG) block with anterior ethmoid (AE) block.

    Treatment: Saline 0.9%

  • Nasal spray with lidocaineTreatment being tested

    This treatment arm will be 4% lidocaine solution in a metered bottle. The Pump size is 0.1 mL per spray dispenses 4 mg of lidocaine per spray - total of 16 mg (vol 0.4 mL). Participants will be instructed to use 2 sprays in each nostril per 24 hours.

    Treatment: Topical solution of 4% lidocaine

  • Nasal spray with Saline (Placebo)Placebo, for comparison

    This treatment arm will be saline solution in a metered bottle. The Pump size is 0.1 mL per spray dispenses 4 mg of saline per spray - total of 16 mg (vol 0.4 mL). Participants will be instructed to use 2 sprays in each nostril per 24 hours.

    Treatment: Saline 0.9%

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Visual Instillation of Sphenopalatine-block Intervention for ONgoing Migraine
Plain-language title
Numbing Medicine Tested Inside the Nose for Migraine HeadachesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
9 November 2026