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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date May 2023
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Arm one will receive Sphenopalatine Ganglion Nerve Block weekly for 4 weeks Arm two will receive Amitriptyline / Elavil daily for 30 Days


Recruitment information / eligibility

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

Study Design


Intervention

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

Locations

Country Name City State
United States Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ New Brunswick New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

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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