As the clinical program for headache medicine has expanded within Norton Neuroscience Institute and further clinical developments have been made in the field of treating headache disorders, our clinical research department has grown. We have participated in several trials that have ultimately led to the FDA approval of products, as well as products that are still investigational in nature.
We participated in the ACT1 trial that led to the FDA clearance of gammaCore for the acute treatment of pain associated with episodic cluster headache. Additionally, for the treatment of chronic cluster, we participated in the Pathway CH-2 trial sponsored by Autonomic Technologies Inc. to evaluate an implantable sphenopalatine ganglion stimulator. This trial recently has released positive results, but the device still is considered experimental. The involvement in these trials has helped expand treatments specific to cluster headache — a condition that has limited treatment options.
We have participated in trials for emerging migraine therapies, including ubrogepant for the acute treatment of migraine, as well as fremanezumab and eptinezumab for the preventive treatment of migraine. These treatments are in the investigational period, hopefully moving forward for use in clinical practice.
At the present time we have trials open, including a Patient-Centered Outcomes Research Institute (PCORI) study on the best way to manage medication-overuse headache. Additionally, trials are open for the use of fremanezumab for the treatment of persistent post traumatic headache, as well as ONZETRA Xsail (sumatriptan nasal powder) for the acute treatment of episodicmigraine adolescents.
Our expansion into clinical research confirms our commitment to be involved in the development of new treatment options for patients who suffer from headache disorders. Additionally, being involved in research allows us to be familiar with new treatment options before they are widely available for use in the general population.
Our research team is staffed by Diana Godwin, R.N., BSN, CCRC, and Deborah Lockridge, R.N., BSN, MSCN, CCRC. For information about enrolling a patient in one of our clinical trials, call (502) 899-6732.
