A Comparison of the Efficacy of 5% Lidocaine Anesthetic to Provide SPGB Vs. Elavil for the Treatment of Transformed Migraine
| Registry | NCT02090998 |
|---|---|
| Status | Terminated - no patients during covid pandemic |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 10 (Actual) |
| Sponsor | Rutgers, The State University of New Jersey (Other) |
| Conditions | Transformed Migraine, Chronic Daily Headache |
| Interventions | SPG Block with 5% Lidocaine gel, Amitriptyline (Procedure, drug) |
| Dates | start 2014-05-01, primary completion 2020-03-16, completion 2020-03-16, first posted 2014-03-19, last updated 2026-06-23 |
| Locations | 1 site in United States |
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All trials for Transformed Migraine All trials for Chronic Daily Headache All trials of SPG Block with 5% Lidocaine gel All trials of Amitriptyline
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| SPG Nerve Block with Lidocaine 5% gel | Active comparator | Procedure: SPG Block with 5% Lidocaine gel; Drug: Amitriptyline | 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 |
| Amitriptyline / Elavil | Active comparator | 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 |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 1. Male and female age 18-90 2. Subject have formal medical diagnosis of migraine headache 3. Subjects currently require treatment for headache 4. Subjects who have received optimal medical management from migraines including triptans (Imitrex, Amerge and Relpax) 5. Subjects who have recieved optimal medical management for migraines including anticonvulsants (Depakote, Lamictal, klonopin Exclusion Criteria: 1. Less than 18 years of age 2. Subjects will be excluded if they are already being treated with lidocaine (patch or other vehicle) for chronic pain 3. Untreated Heart Failure 4. Pregnancy 5. Individuals unwilling to comply with study procedures and follow-up
| Milestone | Amitriptyline / Elavil | SPG Nerve Block With Lidocaine 5% Gel |
|---|---|---|
| Started | 2 | 8 |
| Completed | 2 | 8 |
| Not completed | 0 | 0 |
Time frame: 3 months
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Amitriptyline / Elavil | 0/2 (0.0%) | 0/2 (0.0%) | 0/2 (0.0%) |
| SPG Nerve Block With Lidocaine 5% Gel | 0/8 (0.0%) | 0/8 (0.0%) | 0/8 (0.0%) |
| Facility | City | Country | Status |
|---|---|---|---|
| Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ | New Brunswick, New Jersey | United States |