Studies

Clinical Trials Program

Headache

electroCore’s global headache clinical trial program is presently one of the broadest in the world.

This includes a number of open label trials in both migraine and cluster headache.

At present, the company is now sponsoring four multi-centered randomized trials into cluster headache and migraine – two in Europe and two in the US.

In addition, work is presently underway to gain clinical experiences with the therapy in medication overuse headache (MOH), post-traumatic headache (PTH) and post traumatic stress disorder (PTSD).

US regulatory trials

In the US the FDA regulates VNS through the Medical Device Branch (CDRH) and pivotal trials to support this process are underway.

Canadian Regulatory Status
In Canada Health Canada regulates the availability of medical devices.  In Canada gammaCore is licensed as a Class II Medical Device indicated for the acute and/or prophylactic treatment of Cluster Headache and for the treatment of Migraines in adults.  gammaCore is intended to purchased and used by the patient.  Prior to purchasing gammaCore a patient must first have received a recommendation from his/her gammaCore Certified physician.

Headache studies include:

  • Case Series (3 months) Cluster Headache Acute and Prophylactic Use: 13 patients, data presented at European Headache and Migraine Trust integrated Conference (EHMTiC) in London, September 2012
  • Acute Migraine Treatment IDE Pilot Study: 30 patients, completed Q3:2012, data presented at American Academy of Neurology Meeting in San Diego, March 2013
  • Expanded Case Series Cluster Headache Acute and Prophylactic Use: 21 patients, 9 month data presented at International Headache Congress in Boston, June 2013. 12 month data was presented at International Neuromodulation Society meeting in Berlin, June 2013
  • EVENT Chronic Migraine IDE Pilot Study: 60 patients (randomized, sham controlled, multi-centre) study presented during the American Headache Society (AHS) Meeting, Los Angeles, june, 2014.  Randomized and Open Label data presented as:
    • Non-Invasive Vagus Nerve Stimulation for Chronic Migraine Prevention in a Prospective, Randomized, Sham–Controlled Pilot Study (the EVENT Study): Report from the Double blind Phase.
    • Chronic Migraine Prevention With Non-Invasive Vagus Nerve Stimulation in a Prospective Pilot Study (the EVENT Study): Report from the Open-label Phase.
  • PREVA Chronic Cluster Headache Acute and Prophylactic Use 90 patients (randomized to standard of care, multi-centre EU) study presented during the European Headache and Migraine Trust integrated Conference (EHMTiC), Copenhagen, September, 2014.  Randomized, Open Label and Quality of Life data presented as:
  • Non-Invasive Vagus Nerve Stimulation Using gammaCore for Prevention and Acute Treatment of Chronic Cluster Headache: Report from the Randomized Phase of the PREVA Study.
  • Non-Invasive Vagus Nerve Stimulation Using gammaCore for Prevention and Acute Treatment of Chronic Cluster Headache: Report from the Open-label Phase of the PREVA Study.
  • Quality of Life in Subjects Treated With Non-Invasive Vagus Nerve Stimulation Using gammaCore for the Prevention and Acute Treatment of Chronic Cluster Headache.
  • For details please visit www.ecorelibrary.com
  • Episodic and Chronic Cluster Headache Acute Use (Pivotal US IDE study): 150 patients, enrolling
  • Episodic and Chronic Cluster Headache Acute Use (randomized sham controlled, multi-centre, EU study): 100 patients, enrolling.
  • Rescue treatment of Medication Overuse Headaches (randomized, sham controlled, single centre study).

Other trials

Planned and ongoing trials in fields beyond headache include:

  • A randomized, sham controlled multi-centered trial in epilepsy in Australia.
  • A planned trial on irritable bowel syndrome and functional dyspepsia scheduled to begin in early 2014.
  • Health economic studies in primary care.

Preliminary discussions are being held on clinical observation reviews of the effects of gammaCore therapy among anxiety patients (including panic disorder and bulimia).