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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
Sponsor:
Information provided by (Responsible Party):
William Grubb, M.D., 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


Condition or disease Intervention/treatment Phase
Transformed Migraine Chronic Daily Headache Procedure: SPG Block with 5% Lidocaine gel Drug: Amitriptyline Phase 4

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
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
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
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




Primary Outcome Measures :
  1. Number of Daily Headaches [ Time Frame: Study Day 1 through Study Day 30 ]
    The number of times per day that symptoms occur


Secondary Outcome Measures :
  1. Length of duration of headache [ Time Frame: Study Day 1 though Study Day 30 ]
    The length of time of each symptom


Other Outcome Measures:
  1. 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
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

Information from the National Library of Medicine

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


Locations
United States, New Jersey
Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey

Responsible Party: William Grubb, M.D., Associate Prof., Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02090998     History of Changes
Other Study ID Numbers: 2012002610
First Posted: March 19, 2014    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

Keywords provided by William Grubb, M.D., Rutgers, The State University of New Jersey:
Migraine Headache
Menstrual Migraine
Vascular Headache
Temporal Lobe Seizure

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders
Headache Disorders, Primary
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Amitriptyline, perphenazine drug combination
Amitriptyline
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