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

Phase 4

Terminated

• Conditions: Transformed Migraine; Chronic Daily Headache
• Interventions: Procedure: SPG Block with 5% Lidocaine gel; Drug: Amitriptyline

• Registration Number: NCT02090998
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief 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

Detailed Description

Arm one will receive Sphenopalatine Ganglion Nerve Block weekly for 4 weeks

Arm two will receive Amitriptyline / Elavil daily for 30 Days

Study Timeline

• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-19
• Study Start: 2014-05
• Primary Completion: 2020-03-16
• Study Completion: 2020-03-16
• Results First Submitted: 2021-07-02
• Results First Submitted QC: 2021-11-30
• Results First Posted: 2021-12-29
• Status Verified: 2023-05
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amitriptyline / Elavil	SPG Block with 5% Lidocaine gel	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
SPG Nerve Block with Lidocaine 5% gel	SPG Block with 5% Lidocaine gel	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
SPG Nerve Block with Lidocaine 5% gel	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	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

Primary Outcome Measures

Name	Time	Method
Number of Daily Headaches	Study Day 1 through Study Day 30	The number of times per day that symptoms occur

Trial Locations

Locations (1)

Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ; 🇺🇸 New Brunswick, New Jersey, United States