A Phase 1 interventional study of Ketorolac and Dexamethasone in Chronic Migraine, Cluster Headache and Trigeminal Neuralgia, sponsored by Weill Medical College of Cornell University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-04.
Sponsored by Weill Medical College of Cornell University · Phase 1, Interventional, and Treatment
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.
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.
135 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.
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Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Drug: Ketorolac · Drug: Dexamethasone
Intra-arterial delivery of Ketorolac in the internal maxillary artery, once
Intra-arterial delivery of Dexamethasone in the internal maxillary artery, once.
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
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
Plan to share: No
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This study is withdrawn, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University