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Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache

Primary Purpose

Chronic Migraine, Cluster Headache, Trigeminal Neuralgia

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ketorolac

Dexamethasone

About this trial

This is an interventional treatment trial for Chronic Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Weill Cornell Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intra-Arterial Delivery of Ketorolac and Dexamethasone

Arm Description

Outcomes

Primary Outcome Measures

Number of Procedure-Related Adverse Events

Secondary Outcome Measures

Change in Number of Days of Headache in Subjects with Chronic Migraine

Proportion of Chronic Migraine Patients that achieve at least 50% reduction in days of headache frequency

Proportion of patients with Cluster Headache that achieve 50% reduction in median number of attacks per day

Change in number of days of facial pain for subjects with trigeminal neuralgia

Proportion of patients with trigeminal neuralgia that achieve at least 50% reduction in days of facial pain frequency

Full Information

NCT ID

NCT04353505

First Posted

March 10, 2020

Last Updated

July 31, 2020

Sponsor

Weill Medical College of Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT04353505

Brief Title

Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache

Official Title

Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Withdrawn

Why Stopped

PI closed the study before any enrollment

Study Start Date

October 2020 (Anticipated)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Migraine, Cluster Headache, Trigeminal Neuralgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intra-Arterial Delivery of Ketorolac and Dexamethasone

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Ketorolac

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Procedure-Related Adverse Events

Time Frame

up to 1 hour post-procedure

Title

Number of Procedure-Related Adverse Events

Time Frame

5 hours post procedure

Title

Number of Procedure-Related Adverse Events

Time Frame

2 weeks post procedure

Secondary Outcome Measure Information:

Title

Change in Number of Days of Headache in Subjects with Chronic Migraine

Time Frame