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Visual Instillation of Sphenopalatine-block Intervention for ONgoing Migraine

NCT07764783 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-08-14

No results posted yet for this study

Summary

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.

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?

The 2-month study requires:

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

Conditions

Interventions

DRUG

Topical solution of 4% lidocaine

A rigid endoscopic technique utilizing a cotton pledget as a delivery vehicle of the topical lidocaine allows direct visualization of the target.

DRUG

Saline 0.9%

A rigid endoscopic technique utilizing cotton pledget as a delivery vehicle of the topical saline allows direct visualization of the target.

Sponsors & Collaborators

  • Association of Migraine Disorders

    lead OTHER

Principal Investigators

  • Jerry Schreibstein, MD · Ear, Nose, & Throat Surgeons of Western New England

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-09-30
Completion
2028-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07764783 on ClinicalTrials.gov