Status:
WITHDRAWN
Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Chronic Migraine
Cluster Headache
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of intra-arterial (IA) delivery of Dexamethasone and Ketorolac into the arteries supplying the sphenopalatine ganglion (SPG) - a collec...
Detailed Description
The investigators propose an outpatient, minimally invasive method to deliver Dexamethasone and Ketorolac to the SPG via the intra-arterial route. A microcatheter will be advanced via the radial (pref...
Eligibility Criteria
Inclusion
- Established diagnosis of one of the three following headache or facial pain disorders as defined by the ICHD-329 \[chronic migraine, cluster headache, trigeminal neuralgia\] and failure to respond to two or more preventive therapies
- A. Chronic migraine
- Failure to respond to two or more preventive therapies including Onabotulinumtoxin A, erenumab, fremanezumab, galcanezumab, topiramate, valproic acid, metoprolol, propranolol, timolol, atenolol, nadolol, amitriptyline, nortriptyline, venlafaxine, duloxetine.
- This will include status migrainosus.
- B. Cluster headache
- Failure to respond to Verapamil, AND one other preventive treatment including Prednisone, Dexamethasone, galcanezumab, lithium, valproic acid, topiramate, external vagus nerve stimulation
- C. Trigeminal neuralgia
- Failure to respond to two or more preventive therapies, including: Oxcarbazepine or carbamazepine, and One of the following: gabapentin, pregabalin, baclofen, lamotrigine, phenytoin
Exclusion
- Patients with malignant neoplasm of the pterygopalatine fossa
- Pregnancy, lactation
- Severe allergic reaction to Dexamethasone
- Severe allergic reaction to NSAID
- Renal failure
- Active systemic infection or fever
- Known cerebral vascular disease
- Drug or alcohol abuse
- Opioid dependency (stable doses ok)
- Triptans within 48 hours from the procedure
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04353505
Start Date
October 1 2020
End Date
June 1 2023
Last Update
August 4 2020
Active Locations (1)
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1
Weill Cornell Medicine
New York, New York, United States, 10021