Randomised data show gammaCore significantly reduces cluster headache attack frequency

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At the biannual European Headache and Migraine Trust International Conference (EHMTIC) meeting in Copenhagen, more than 900 neurologists and other headache specialists came to hear about the latest advances in managing severe headache conditions, including electroCore’s gammaCore therapy. The attendees heard that a large scale randomised clinical trial of the gammaCore therapy in chronic cluster headache not only significantly reduced the number of cluster headache attacks beyond the best available standard of care, but also that patients experienced a greater reduction in number of attacks the longer they stayed on treatment.

Treatment with gammaCore also resulted in meaningful improvements in quality of life and a reduction in the use of traditional rescue medications such as injectable sumatriptan and oxygen. Cluster headache is a condition that affects approximately the same number of people as multiple sclerosis, and is considered by experts to be one of the most painful medical conditions known to medicine. GammaCore’s demonstrated effects represent a significant breakthrough in the care of patients with this debilitating condition.

More particularly, the Prevention and acute treatment of chronic cluster headache (PREVA) randomised and open label trial data were presented in three poster presentations and at a breakout symposium, highlighting the following key findings:

  • Patients receiving gammaCore plus standard of care achieved a 43.4% reduction in the number of weekly cluster headache attacks compared with 12.5% (p=0.002) in patients treated with the best available standard of care.
  • Treatment with gammaCore was more effective the longer patients remained on therapy.
  • The quality of life measurements measured by EQ-5-3L VAS and HIT-6 were meaningful for those on gammaCore.
  • Patients on gammaCore (in the randomised phase) reduced their use of sub cutaneous sumatriptan and oxygen by >60%.
  • Nearly 64% indicated that they would recommend the use of gammaCore to a family member or friend.
  • 56% of patients found treatment with gammaCore very easy to use.
  • Treatment with gammaCore was safe and can be used in combination with drug treatments.
  • Device related adverse events were primarily mild and transient.

Charly Gaul, director of the Migraine and Headache Clinic in Königstein, Germany, who was the principal investigator of the PREVA study, and presented the data from this study during the symposium, comments, “This study is one of the few well controlled, randomised studies of any preventative treatment for cluster headache. The ability of electroCore’s gammaCore therapy to significantly reduce the number of weekly cluster headaches in these chronic patients suggests it offers an important new option for this extremely painful and difficult to manage condition.”

The PREVA trial, which is part of the largest trial program ever carried out in cluster headache, was conducted at ten sites across Europe with 97 patients enrolled. Ninety-three were randomized to participate following the initial baseline data collection. Forty-five of the patients were randomly selected to use gammaCore plus their usual treatment and 48 to the best available standard of care. The baseline data collection period was two-weeks, followed by the four-week randomized phase. All the patients from both arms were asked to continue on active therapy for an additional four-week open label phase.

The dosing of the therapy used in the PREVA trial was three, 120-second stimulations, delivered at two time points during each day.

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