Transformed MigrainePhase 4NCT02090998
Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines
A Phase 4 study testing SPG Block with 5% Lidocaine gel and Amitriptyline in people with Transformed Migraine and Chronic Daily Headache, run by Rutgers, The State University of New Jersey at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transformed Migraine, Chronic Daily Headache
- What is being tested?
- SPG Block with 5% Lidocaine gel and Amitriptyline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 16 Mar 2020
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ
New Brunswick, New Jersey, 08901
About this study
Official title: 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
Read the detailed description
Arm one will receive Sphenopalatine Ganglion Nerve Block weekly for 4 weeks
Arm two will receive Amitriptyline / Elavil daily for 30 Days
- Conditions
- Transformed Migraine, Chronic Daily Headache
- Being tested
- SPG Block with 5% Lidocaine gel, Amitriptyline
- Keywords
- Migraine Headache, Menstrual Migraine, Vascular Headache, Temporal Lobe Seizure
- Medical subject headings
- Headache Disorders, Migraine Disorders, Vascular Headaches, Epilepsy, Temporal Lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPG Block with 5% Lidocaine gelProcedure or surgery
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
AmitriptylineDrug
Also called Elavil
The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days
| Study group | Role | What they receive |
|---|---|---|
| SPG Nerve Block with Lidocaine 5% gel | Active comparator | 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 Receives: Procedure: SPG Block with 5% Lidocaine gel; Drug: Amitriptyline |
| Amitriptyline / Elavil | Active comparator | 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 Receives: Procedure: SPG Block with 5% Lidocaine gel; Drug: Amitriptyline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Daily Headaches
The number of times per day that symptoms occur
Measured: Study Day 1 through Study Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startMay 2014
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Why it stopped: no patients during covid pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Transformed MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Grubb, M.D., Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090998
- Sponsor's protocol ID
- 2012002610
- Status last verified
- May 2023
- First submitted
- 17 Mar 2014
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No