Intra-arterial Sphenopalatine Ganglion Block for Patients... | NCT04353505

Studies
Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache

NCT04353505

Sponsor

Weill Medical College of Cornell University

Status

Withdrawn

Last Update Posted

Aug 4, 2020Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Chronic Migraine
Cluster Headache
Trigeminal Neuralgia

Interventions

Ketorolac
Dexamethasone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI closed the study before any enrollment

Expanded Access Info

Start Date

Oct 2020Estimated

Primary Completion Date

Jun 2022Estimated

Completion Date

Jun 2023Estimated

First Submitted Date

Mar 10, 2020

First Submission Date that Met QC Criteria

Apr 17, 2020

First Posted Date

Apr 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2020

Last Update Posted Date

Aug 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Intra-Arterial Delivery of Ketorolac and Dexamethasone	Experimental		Drug: Ketorolac Drug: Dexamethasone

Name	Type	Description	Arm Group Labels	Other Names
Ketorolac	Drug	Intra-arterial delivery of Ketorolac in the internal maxillary artery, once	Intra-Arterial Delivery of Ketorolac and Dexamethasone

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D051303	Trigeminal Autonomic Cephalalgias
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases

ID	Term
D007213	Indomethacin
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring