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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Withdrawn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
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

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
Number of Procedure-Related Adverse Events
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

First Posted
March 10, 2020
Last Updated
July 31, 2020
Sponsor
Weill Medical College of Cornell University
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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
No
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
1 week, 2 weeks, 4 weeks, 6 weeks
Title
Proportion of Chronic Migraine Patients that achieve at least 50% reduction in days of headache frequency
Time Frame
1 week, 2 weeks, 4 weeks, 6 weeks
Title
Proportion of patients with Cluster Headache that achieve 50% reduction in median number of attacks per day
Time Frame
1 week, 2 weeks, 4 weeks, 6 weeks
Title
Change in number of days of facial pain for subjects with trigeminal neuralgia
Time Frame
1 week, 2 weeks, 4 weeks, 6 weeks
Title
Proportion of patients with trigeminal neuralgia that achieve at least 50% reduction in days of facial pain frequency
Time Frame
1 week, 2 weeks, 4 weeks, 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athos Patsalides, MD, MPH
Organizational Affiliation
WCMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache

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