A Phase 2 interventional study of Topical solution of 4% lidocaine and Saline 0.9% in Migraine, Facial Pain or Pressure and Headache, sponsored by Association of Migraine Disorders. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Association of Migraine Disorders · Phase 2, Interventional, and Treatment
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:
The 3-month study requires:
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 74 is close to the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Association of Migraine Disorders is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At least 2 of 3 positives (a, b, c) below on the ID Migraine Screener from the American Headache Society:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Topical solution of 4% lidocaine
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.
Drug: Saline 0.9%
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.
Drug: Topical solution of 4% lidocaine
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.
Drug: Saline 0.9%
A rigid endoscopic technique utilizing a cotton pledget as a delivery vehicle of the topical lidocaine allows direct visualization of the target.
A rigid endoscopic technique utilizing cotton pledget as a delivery vehicle of the topical saline allows direct visualization of the target.
Acute headache pain
Acute headache pain will be measured using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible), before (pre-treatment) and after the endoscopy procedure (post-treatment) at 15, 30, 60 min and 24 hours.
Time frame: Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment.
Acute facial pain or pressure
Acute facial pain or pressure will be measured using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible), before (pre-treatment) and after the endoscopy procedure (post-treatment) at 15, 30, 60 min and 24 hours.
Time frame: Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment.
Acute neck pain
Acute neck pain will be measured using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible), before (pre-treatment) and after the endoscopy procedure (post-treatment) at 15, 30, 60 min and 24 hours.
Time frame: Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment.
Headache days per month
Daily headache pain recorded in a mobile application. Recorded as binary (Yes/No) and rated using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible).
Time frame: Daily, following enrollment to right before the block treatment at 1 month and again from right after the treatment to 1 month after treatment. During nasal spray treatment (1 week) and 30 days following spray treatment.
Facial pain or pressure days per month
Daily facial pain or pressure recorded in a mobile application. Recorded as binary (Yes/No) and rated using a 0 to 10 Likert scale (0 representing No Pain or pressure, and 10 representing the worst pain or pressure possible).
Time frame: Daily, following enrollment to right before the block treatment at 1 month and again from right after the treatment to 1 month after treatment. During nasal spray treatment (1 week) and 30 days following spray treatment.
Neck pain days per month
Daily neck pain recorded in a mobile application. Recorded as binary (Yes/No) and rated using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible).
Time frame: Daily, following enrollment to right before the block treatment at 1 month and again from right after the treatment to 1 month after treatment. During nasal spray treatment (1 week) and 30 days following spray treatment.
Sinonasal Outcome Test- 22 (SNOT-22)
SNOT-22 is A validated 22-item questionnaire that measures the health-related quality of life (HRQoL) of patients with chronic rhinosinusitis (CRS). The SNOT-22 is scored by adding the individual values of 22 symptom and quality-of-life items. Each item is graded on a scale from 0 to 5, yielding a total cumulative score between 0 and 110, where higher numbers reflect more severe symptoms and a greater impact on health.
Time frame: Immediately before the treatment at 1 month and again 1 month after the endoscopy procedure, and again 1 month after the nasal spray treatment.
Migraine Disability Assessment (MIDAS)
MIDAS is a valid and reliable short questionnaire for assessment of headache related disability. Respondents will enter the total number of days affected in the last one month for: Work or school: Days missed. Work or school productivity: Days where productivity was reduced by half or more. Household work: Days missed. Household work productivity: Days where productivity was reduced by half or more. Family, social, or leisure activities: Days missed.
Time frame: Immediately before the treatment at 1 month and again 1 month after the endoscopy procedure, and again 1 month after the nasal spray treatment.
Additional headache symptoms
Additional headache symptoms recorded in a mobile application. Recorded as binary (Yes/No) and rated using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible).
Time frame: Daily, following enrollment to right before the block treatment at 1 month and again from right after the treatment to 1 month after treatment. During nasal spray treatment (1 week) and 30 days following spray treatment.
Rescue medications
Rescue medication needed, recorded in a mobile application. Recorded as binary (Yes/No).
Time frame: Daily, following enrollment to right before the block treatment at 1 month and again from right after the treatment to 1 month after treatment. During nasal spray treatment (1 week) and 30 days following spray treatment.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Sep 2028, 20 months later.
Of 73 phase 2 interventional studies under Migraine Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 20 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 9, 2026: start Sep 2026 → Jan 2027 and completion Sep 2028 → Jan 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Association of Migraine Disorders