A Phase 4 interventional study of SPG Block with 5% Lidocaine gel and Amitriptyline in Transformed Migraine and Chronic Daily Headache, sponsored by Rutgers, The State University of New Jersey. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Rutgers, The State University of New Jersey · Phase 4, Interventional, and Prevention
This study will compare a local anesthetic technique that has been used to treat subjects suffering from transformed migraines (chronic migraines) versus medical management with traditional antidepressant Amitriptyline / Elavil.
Subjects will be randomized into one of two treatment groups to compare the safety and efficacy of the therapies. Subjects will recieve either sphenopalatine ganglion nerve block with 5% lidocaine gel into the nasopharynx or medical management with traditional antidepressants, Elavil, to produce a reduction in the frequency and severity of the headache.
We propose that there will be a difference in the outcomes when comparing the two methods of treating transformed migraines and that one research arm will result in more patient satisfaction and greater efficacy in the treatment of subjects
Arm one will receive Sphenopalatine Ganglion Nerve Block weekly for 4 weeks
Arm two will receive Amitriptyline / Elavil daily for 30 Days
Exclusion Criteria:
Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated
Procedure: SPG Block with 5% Lidocaine gel · Drug: Amitriptyline
Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated
Procedure: SPG Block with 5% Lidocaine gel · Drug: Amitriptyline
cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia
The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days
Also known as: Elavil
Number of Daily Headaches
The number of times per day that symptoms occur
Time frame: Study Day 1 through Study Day 30
Duration of Inactivity Associated With Headaches
The time after events that effects patient activity level
Time frame: Study Day 1 thorugh Study Day 30
| Milestone | Amitriptyline / Elavil | SPG Nerve Block With Lidocaine 5% Gel |
|---|---|---|
| Started | 2 | 8 |
| Completed | 2 | 8 |
| Not completed | 0 | 0 |
The number of times per day that symptoms occur
| Number of Daily Headaches | Amitriptyline / Elavil | SPG Nerve Block With Lidocaine 5% Gel |
|---|---|---|
| Number of Daily Headaches | 20.5 ± 0.5 | 13.4 ± 10.4 |
The time after events that effects patient activity level
Results for this outcome have not been posted.
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Amitriptyline / Elavil | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| SPG Nerve Block With Lidocaine 5% Gel | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | Amitriptyline / Elavil | SPG Nerve Block With Lidocaine 5% Gel | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 8 | 10 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Amitriptyline / Elavil | SPG Nerve Block With Lidocaine 5% Gel | Total |
|---|---|---|---|
| Mean | 46 (45 to 48) | 59 (39 to 84) | 56 (39 to 84) |
| Sex: Female, Male(Participants) | Amitriptyline / Elavil | SPG Nerve Block With Lidocaine 5% Gel | Total |
|---|---|---|---|
| Female | 2 | 5 | 7 |
| Male | 0 | 3 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Amitriptyline / Elavil | SPG Nerve Block With Lidocaine 5% Gel | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 8 | 10 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Amitriptyline / Elavil | SPG Nerve Block With Lidocaine 5% Gel | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 8 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Amitriptyline / Elavil | SPG Nerve Block With Lidocaine 5% Gel | Total |
|---|---|---|---|
| United States | 2 | 8 | 10 |
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Rutgers, The State University of New Jersey