Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Migraine; Cluster Headache; Trigeminal Neuralgia
• Intervention / Treatment: Drug: Ketorolac; Drug: Dexamethasone

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 (preferably) or the femoral artery (in case the radial approach is not feasible) using fluoroscopic guidance and standard interventional techniques, into the distal internal maxillary artery. This artery is a branch of the external carotid artery and supplies the territory of the sphenopalatine ganglion. The microcatheter will be advanced to the ostium of the distal small branches that supply the SPG (i.e. small arteries feeding the vasa nervosum). Once the microcatheter is in a good position, 15 mg Dexamethasone Sodium Phosphate and 15 mg of Ketorolac Tromethamine will be infused over 30 minutes.

The procedure will be performed with local anesthetic at the arterial puncture site. Conscious sedation will be used for anxious participants. After the procedure, the participant will be observed for 5 hours in ICU setting and then discharged to home.

The procedure will be performed unilaterally for participants with cluster headache and trigeminal neuralgia. The procedure could be performed bilaterally for participants with migraine.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intra-Arterial Delivery of Ketorolac and Dexamethasone	Drug: Ketorolac; Intra-arterial delivery of Ketorolac in the internal maxillary artery, once; Drug: Dexamethasone; Intra-arterial delivery of Dexamethasone in the internal maxillary artery, once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Procedure-Related Adverse Events	up to 1 hour post-procedure
Number of Procedure-Related Adverse Events	5 hours post procedure
Number of Procedure-Related Adverse Events	2 weeks post procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Number of Days of Headache in Subjects with Chronic Migraine	1 week, 2 weeks, 4 weeks, 6 weeks
Proportion of Chronic Migraine Patients that achieve at least 50% reduction in days of headache frequency	1 week, 2 weeks, 4 weeks, 6 weeks
Proportion of patients with Cluster Headache that achieve 50% reduction in median number of attacks per day	1 week, 2 weeks, 4 weeks, 6 weeks
Change in number of days of facial pain for subjects with trigeminal neuralgia	1 week, 2 weeks, 4 weeks, 6 weeks
Proportion of patients with trigeminal neuralgia that achieve at least 50% reduction in days of facial pain frequency	1 week, 2 weeks, 4 weeks, 6 weeks

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Athos Patsalides, MD, MPH, WCMC

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Headache Disorders, Primary; Headache Disorders; Facial Nerve Diseases; Trigeminal Autonomic Cephalalgias; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Headache; Cluster Headache; Trigeminal Neuralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Ketorolac
• Other Study ID Numbers: 19-11021096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No