Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines

• Status: Unknown status
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination; Lidocaine

Criteria

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