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

NCT02090998 | Terminated Phase 4 Results

• 1 other identifier: 2012002610
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Transformed Migraine; Chronic Daily Headache

Keywords

Migraine Headache; Menstrual Migraine; Vascular Headache; Temporal Lobe Seizure

Outcome Measures

Primary Outcomes (1)

• Number of Daily Headaches

  The number of times per day that symptoms occur

  Study Day 1 through Study Day 30

Other Outcomes (1)

• Duration of Inactivity Associated With Headaches

  Study Day 1 thorugh Study Day 30

Study Arms (2)

SPG Nerve Block with Lidocaine 5% gel

ACTIVE COMPARATOR

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

ACTIVE COMPARATOR

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

Interventions

SPG Block with 5% Lidocaine gel PROCEDURE

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

Amitriptyline / Elavil; SPG Nerve Block with Lidocaine 5% gel

Amitriptyline DRUG

The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days

Also known as: Elavil

Amitriptyline / Elavil; SPG Nerve Block with Lidocaine 5% gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female age 18-90
• Subject have formal medical diagnosis of migraine headache
• Subjects currently require treatment for headache
• Subjects who have received optimal medical management from migraines including triptans (Imitrex, Amerge and Relpax)
• Subjects who have recieved optimal medical management for migraines including anticonvulsants (Depakote, Lamictal, klonopin

You may not qualify if:

• Less than 18 years of age
• Subjects will be excluded if they are already being treated with lidocaine (patch or other vehicle) for chronic pain
• Untreated Heart Failure
• Pregnancy
• Individuals unwilling to comply with study procedures and follow-up

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Headache Disorders; Migraine Disorders; Vascular Headaches; Epilepsy, Temporal Lobe

Interventions

Amitriptyline

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Cerebrovascular Disorders; Headache Disorders, Secondary; Vascular Diseases; Cardiovascular Diseases; Epilepsies, Partial; Epilepsy; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: william grubb md
• Organization: Rutgers/RWJMS

grubbwr@rwjms.rutgers.edu

7322357827

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof.

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 19, 2014
• Study Start: May 1, 2014
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: July 16, 2024
• Results First Posted: December 29, 2021

Record last verified: 2023-05

Locations

US (1)