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Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines

Primary Purpose

Transformed Migraine, Chronic Daily Headache

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
SPG Block with 5% Lidocaine gel
Amitriptyline
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Transformed Migraine focused on measuring Migraine Headache, Menstrual Migraine, Vascular Headache, Temporal Lobe Seizure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SPG Nerve Block with Lidocaine 5% gel

Amitriptyline / Elavil

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Daily Headaches
The number of times per day that symptoms occur

Secondary Outcome Measures

Full Information

First Posted
March 17, 2014
Last Updated
May 3, 2023
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT02090998
Brief Title
Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines
Official Title
A Comparison of the Efficacy of 5% Lidocaine Anesthetic to Provide SPGB Vs. Elavil for the Treatment of Transformed Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
no patients during covid pandemic
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
March 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transformed Migraine, Chronic Daily Headache
Keywords
Migraine Headache, Menstrual Migraine, Vascular Headache, Temporal Lobe Seizure

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPG Nerve Block with Lidocaine 5% gel
Arm Type
Active Comparator
Arm Description
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
Arm Title
Amitriptyline / Elavil
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
SPG Block with 5% Lidocaine gel
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Amitriptyline
Other Intervention Name(s)
Elavil
Intervention Description
The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days
Primary Outcome Measure Information:
Title
Number of Daily Headaches
Description
The number of times per day that symptoms occur
Time Frame
Study Day 1 through Study Day 30
Other Pre-specified Outcome Measures:
Title
Duration of Inactivity Associated With Headaches
Description
The time after events that effects patient activity level
Time Frame
Study Day 1 thorugh Study Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines

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