- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02090998
Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines
A Comparison of the Efficacy of 5% Lidocaine Anesthetic to Provide SPGB Vs. Elavil for the Treatment of Transformed Migraine
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days
Other Names:
|
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
|
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
The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Daily Headaches
Time Frame: Study Day 1 through Study Day 30
|
The number of times per day that symptoms occur
|
Study Day 1 through Study Day 30
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Inactivity Associated With Headaches
Time Frame: Study Day 1 thorugh Study Day 30
|
The time after events that effects patient activity level
|
Study Day 1 thorugh Study Day 30
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Headache Disorders, Primary
- Migraine Disorders
- Headache
- Headache Disorders
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Adrenergic Uptake Inhibitors
- Lidocaine
- Amitriptyline
Other Study ID Numbers
- 2012002610
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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