Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache

NCT04353505 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 19-11021096
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Migraine; Cluster Headache; Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (1)

Intra-Arterial Delivery of Ketorolac and Dexamethasone

EXPERIMENTAL

Drug: Ketorolac; Drug: Dexamethasone

Interventions

Ketorolac DRUG

Intra-arterial delivery of Ketorolac in the internal maxillary artery, once

Intra-Arterial Delivery of Ketorolac and Dexamethasone

Dexamethasone DRUG

Intra-arterial delivery of Dexamethasone in the internal maxillary artery, once.

Intra-Arterial Delivery of Ketorolac and Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Cluster Headache; Trigeminal Neuralgia

Interventions

Ketorolac; Dexamethasone

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Athos Patsalides, MD, MPH

  WCMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: April 20, 2020
• Study Start: October 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)