Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines
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ClinicalTrials.gov Identifier: NCT02090998 |
Recruitment Status :
Enrolling by invitation
First Posted : March 19, 2014
Last Update Posted : September 5, 2018
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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
Condition or disease | Intervention/treatment | Phase |
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Transformed Migraine Chronic Daily Headache | Procedure: SPG Block with 5% Lidocaine gel Drug: Amitriptyline | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Comparison of the Efficacy of 5% Lidocaine Anesthetic to Provide SPGB Vs. Elavil for the Treatment of Transformed Migraine |
Study Start Date : | May 2014 |
Estimated Primary Completion Date : | July 2021 |
Estimated Study Completion Date : | July 2021 |

Arm | Intervention/treatment |
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Active Comparator: SPG Nerve Block with Lidocaine 5% 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
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Procedure: SPG Block with 5% Lidocaine gel
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 Drug: Amitriptyline The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days
Other Name: Elavil |
Active Comparator: Amitriptyline / Elavil
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
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Procedure: SPG Block with 5% Lidocaine gel
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 Drug: Amitriptyline The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days
Other Name: Elavil |
- Number of Daily Headaches [ Time Frame: Study Day 1 through Study Day 30 ]The number of times per day that symptoms occur
- Length of duration of headache [ Time Frame: Study Day 1 though Study Day 30 ]The length of time of each symptom
- Duration of inactivity associated with headaches [ Time Frame: Study Day 1 thorugh Study Day 30 ]The time after events that effects patient activity level

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090998
United States, New Jersey | |
Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ | |
New Brunswick, New Jersey, United States, 08901 |
Responsible Party: | William Grubb, M.D., Associate Prof., Rutgers, The State University of New Jersey |
ClinicalTrials.gov Identifier: | NCT02090998 |
Other Study ID Numbers: |
2012002610 |
First Posted: | March 19, 2014 Key Record Dates |
Last Update Posted: | September 5, 2018 |
Last Verified: | September 2018 |
Migraine Headache Menstrual Migraine Vascular Headache Temporal Lobe Seizure |
Migraine Disorders Headache Disorders Headache Headache Disorders, Primary Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Lidocaine Amitriptyline Amitriptyline, perphenazine drug combination Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors |