Chronic MigrainePhase 1NCT04353505
Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache
A Phase 1 study testing Ketorolac and Dexamethasone in people with Chronic Migraine and Cluster Headache, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Migraine, Cluster Headache, Trigeminal Neuralgia
- What is being tested?
- Ketorolac and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2020to Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
- Cluster headache
- Failure to respond to Verapamil, AND one other preventive treatment including Prednisone, Dexamethasone, galcanezumab, lithium, valproic acid, topiramate, external vagus nerve stimulation
- 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
Who cannot join
- 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
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- Known cerebral vascular disease
- Drug or alcohol abuse
- Opioid dependency (stable doses ok)
- Triptans within 48 hours from the procedure
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Migraine, Cluster Headache, Trigeminal Neuralgia
- Being tested
- Ketorolac, Dexamethasone
- Medical subject headings
- Cluster Headache, Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Intra-arterial delivery of Ketorolac in the internal maxillary artery, once
DexamethasoneDrug
Intra-arterial delivery of Dexamethasone in the internal maxillary artery, once.
| Study group | Role | What they receive |
|---|---|---|
| Intra-Arterial Delivery of Ketorolac and Dexamethasone | Experimental | Not described Receives: Drug: Ketorolac; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Procedure-Related Adverse Events
Measured: up to 1 hour post-procedure
Number of Procedure-Related Adverse Events
Measured: 5 hours post procedure
Number of Procedure-Related Adverse Events
Measured: 2 weeks post procedure
Secondary outcomes (5)
Change in Number of Days of Headache in Subjects with Chronic Migraine
Measured: 1 week, 2 weeks, 4 weeks, 6 weeks
Proportion of Chronic Migraine Patients that achieve at least 50% reduction in days of headache frequency
Measured: 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
Measured: 1 week, 2 weeks, 4 weeks, 6 weeks
Change in number of days of facial pain for subjects with trigeminal neuralgia
Measured: 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
Measured: 1 week, 2 weeks, 4 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study startOct 2020 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: PI closed the study before any enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Athos Patsalides, MD, MPH, Principal investigator, WCMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353505
- Sponsor's protocol ID
- 19-11021096
- Status last verified
- Jul 2020
- First submitted
- 10 Mar 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache
- ClinicalTrials.gov ID
- NCT04353505
- Acronym / sponsor ID
- 19-11021096
- Conditions
- Chronic Migraine, Cluster Headache, Trigeminal Neuralgia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI closed the study before any enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-Arterial Delivery of Ketorolac and Dexamethasone | Experimental | Drug: Ketorolac, Drug: Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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.
- Cluster headache
Key exclusion criteria (10 listed)
- Patients with malignant neoplasm of the pterygopalatine fossa
- Pregnancy, lactation
- Severe allergic reaction to Dexamethasone
- Severe allergic reaction to NSAID
- Renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetorolacIntra-arterial delivery of Ketorolac in the internal maxillary artery, once | Drug | Intra-Arterial Delivery of Ketorolac and Dexamethasone |
| DexamethasoneIntra-arterial delivery of Dexamethasone in the internal maxillary artery, once. | Drug | Intra-Arterial Delivery of Ketorolac and Dexamethasone |
Primary outcome
Number of Procedure-Related Adverse Events
Time frame: up to 1 hour post-procedure
Number of Procedure-Related Adverse Events
Time frame: 5 hours post procedure
Number of Procedure-Related Adverse Events
Time frame: 2 weeks post procedure
5 secondary outcomes
Change in Number of Days of Headache in Subjects with Chronic Migraine
Time frame: 1 week, 2 weeks, 4 weeks, 6 weeks
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
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
Change in number of days of facial pain for subjects with trigeminal neuralgia
Time frame: 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
Time frame: 1 week, 2 weeks, 4 weeks, 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athos Patsalides, MD, MPH principal investigator
WCMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketorolac and Dexamethasone in people with Chronic Migraine and Cluster Headache, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Procedure-Related Adverse Events (time frame: up to 1 hour post-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020; AzTrials last refreshed its copy on 8 Nov 2026.