Overview

Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache

Status:
Withdrawn
Trial end date:
2023-06-01
Target enrollment:
0
Participant gender:
All
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 collection of neurons that plays an important role in headache disorders - in patients with refractory migraine, cluster headache and trigeminal neuralgia. All patients must fail standard treatments prior to enrollment in the trial.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Weill Medical College of Cornell University
Treatments:
Dexamethasone
Ketorolac
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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