Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache

Withdrawn before enrolling · Phase 1

Conditions studied: Chronic Migraine, Cluster Headache, Trigeminal Neuralgia

In brief

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.

Key facts

Study ID

NCT04353505

Run by

Weill Medical College of Cornell University

People needed

0

Starts

2020-10-01

Expected to finish

2023-06-01

Last updated by the study team

2020-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Weill Cornell Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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