Chronic Daily Headache Clinical Trial
Official title:
A Comparison of the Efficacy of 5% Lidocaine Anesthetic to Provide SPGB Vs. Elavil for the Treatment of Transformed Migraine
NCT number | NCT02090998 |
Other study ID # | 2012002610 |
Secondary ID | |
Status | Terminated |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2014 |
Est. completion date | March 16, 2020 |
Verified date | May 2023 |
Source | Rutgers, The State University of New Jersey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 10 |
Est. completion date | March 16, 2020 |
Est. primary completion date | March 16, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ | New Brunswick | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Rutgers, The State University of New Jersey |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Duration of Inactivity Associated With Headaches | The time after events that effects patient activity level | Study Day 1 thorugh Study Day 30 | |
Primary | Number of Daily Headaches | The number of times per day that symptoms occur | Study Day 1 through Study Day 30 |
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